diabetes detected by screening in people with screen-detected diabetes in primary care. The ADDITION diabetes patients risk profile, thus …

Motivational interviewing in intensive treatment of Type 2 diabetes detected by screening in general practice
Overall effect of a course in Motivational interviewing

PhD thesis Sune Leisgaard Mørck Rubak

Department and Research Unit of General Practice Faculty of Health Sciences University of Aarhus Denmark 2005

PhD thesis Motivational interviewing in intensive treatment of Type 2 diabetes in general practice Overall effect of a course in Motivational interviewing Sune Rubak 1st edition, 2005 Print: Fællestrykkeriet for Sundhedsvidenskab, University of Aarhus ISBN This PhD thesis has been accepted for the defence of the medical PhD by the Faculty of Health Science, University of Aarhus and was defended on February 22th, 2005 Supervisors: Professor, MD, GP, PhD Bo Christensen, Director of Department of General Practice, University of Aarhus, Denmark Associate Professor, MD, PhD Annelli Sandbæk, Department of General Practice, University of Aarhus, Denmark Professor, MD, GP, DMSc Torsten Lauritzen, Department of General Practice, University of Aarhus, Denmark Opponents: Professor, Consultant, MD, DMSc Povl Munk-Jørgensen, Director of Research Unit of Psychiatric Department,
Aalborg Hospital, University of Aarhus, Denmark Chair Associate Professor, Consultant, MD, DMSc Birger Thorsteinsson, Department of Medicine F, Hillerød Hospital, Denmark Professor, MD, GP, DMSc Flemming Bro, Director of Department of General Practice, University of Southern Denmark, Denmark Steno Diabetes Center, Gentofte Department and Research Unit of General Practice University of Aarhus Vennelyst Boulevard 6 DK-8000 Aarhus C Denmark Email: sunerubak@dadlnetdk or sr@almaudk wwwalmaudk All rights reserved No parts of this publication may be reproduced, stored in retrieval systems, or transmitted in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without indication of source

Preface

Outline of this PhD thesis and the PhD project
This thesis is based on the ADDITION-study, the Anglo-Danish-Ducth study of intensive treatment in people with screen-detected diabetes in primary care The ADDITION-study was developed and implemented in cooperation between the Department of General Practice and the Steno Diabetes Centre The ADDITION-study investigates the effects of screening and intensive treatment including poly-pharmacological treatment and
behavioural change, on patients with Type 2 diabetes The ADDITION-study is an ongoing study encompassing three countries, The Netherlands, England and Denmark In Denmark, the study is represented in five counties, Aarhus, Copenhagen, Ringkoebing, Ribe and South Jutland counties In this thesis, the effect of Motivational interviewing was evaluated in a cluster-randomised controlled trial carried out in the counties of Aarhus and Copenhagen, Denmark, 2001 This PhD thesis is a part of the ADDITIONstudy It specifically explores the effect after one year of Motivational interviewing on newly diagnosed Type 2 diabetes patients detected by screening This thesis focuses on whether GPs using Motivational interviewing can increase adherence to and effect of intensive treatment of Type 2 diabetes patients risk profile, thus reaching treatment goals The concept of Motivational interviewing is introduced in Chapter 1, which also offers a summary of the use of this concept in research and practice and a presentation of the rationale why Motivational interviewing was chosen as the means of intervention The aim of the PhD study is presented at the end of Chapter 1 Chapter 2 features a review of
previous research on Motivational interviewing and its implications for practice and a meta-analysis on its effect In Chapter 3 the effects of a training course in Motivational interviewing for general practitioners GPs are presented The chapter addresses the questions whether the GPs aquired the methods of Motivational interviewing and if they used Motivational interviewing in their daily work The next step focused on the effect of Motivational interviewing on patients lifestyle and behavioural change Chapter 4 hence addresses the questions whether the GPs use of Motivational interviewing changed the patients contemplation of changing behaviour and if they did, indeed, change lifestyle behaviour Finally, the effects of Motivational interviewing on patients risk profile and adherence to intensive treatment are outlined in Chapter 5 Chapters 6 to 9 offer a comprehensive and more general discussion of the methods used and the results presented in the articles, adding perspective to the research questions posed Finally, Chapters 10 and 11 present English and Danish summaries References used throughout the thesis are listed in citation order Appendices provide an outline of the study
flowcharts, the educational programme of Motivational interviewing and the questionnaires and case record forms in Danish Appendix A-D

This PhD thesis is based on the following articles:
I Rubak S, Christensen B, Sandbaek A, Lauritzen T Motivational interviewing, a systematic review and a meta-analysis British Journal of General Practice Accepted 2004 Rubak S, Sandbaek A, Lauritzen T, Borch-Johnsen K, Christensen B How does an education and training course in Motivational interviewing influence general practitioners professional behaviour ADDITION Denmark British Journal of General Practice Submitted 2004 Rubak S, Sandbaek A, Lauritzen T, Borch-Johnsen K, Christensen B Effect of Motivational interviewing on beliefs and behaviour among patients with Type 2 diabetes detected by screening ADDITION Denmark Prepared for publication 2004 Rubak S, Sandbaek A, Lauritzen T, Borch-Johnsen K, Christensen B No effect of Motivational interview on risk profile in patients with Type 2 diabetes detected by screening A one-year follow-up of a RCT ADDITION Denmark Prepared for publication 2004

III

Motivation
After my graduation from the University of Aarhus in 1998, I began my
postgraduate career as a house officer At this time I came into contact with the Department of General Practice while doing a small research project During this project, I felt that the department had pleasant, productive and appealing atmosphere However, I started as a senior house officer at the Department of Paediatrics, Skejby Hospital, where I was much inspired by the clinical work with children I found myself standing with one leg in two worlds, General Practice or Paediatrics This dilemma was put into perspective by my family situation as a husband and father of two children, Johan and Astrid The challenge was to combine this wonderful family life with a productive and meaningful, clinical career and a PhD presented itself as a natural solution The Department of General Practice proposed a project on Motivational interviewing I had a meeting with Professor Carl-Erik Mabeck, my mentor in Motivational interviewing, and was intrigued by the possibilities of Motivational interviewing and the lack of research in this field This was a method which, if it proved effective, could be used in both General Practice and in Paediatrics After having caught up on the subject of
Motivational interviewing, I decided that this was the right area for me to do further research in and began my PhD project

Acknowledgements
The study would never have succeeded had it not been for the tremendous support I have received from my colleagues, from research funds and from my family My colleagues in general practice in the County of Aarhus and the County of Copenhagen have involved themselves strongly in the project and accepted to be randomized and then undertaken all the hard work of attending courses, implementing the methods and recruiting the patients to the project I am truly grateful for their participation and support for this project I would also like to thank the practice staff and all the patients who spent much time filling in the questionnaires and case record forms I am indebted to my supervisors, Professor Bo Christensen for being there all the time during the study, Associate Professor Annelli Sandbæk for having paid close attention and for having the feel of the project in its different phases, Professor Torsten Lauritzen and Professor Knut BorchJohnsen for their work launching and supporting the ADDITION-study Finally, I am greatly indebted to my
mentor Professor Carl-Erik Mabeck for sharing his profound knowledge on Motivational interviewing, his guidance and willingness to provide the right amount of inspiration and motivation when needed I owe my sincere thanks to the flourishing research atmosphere at the Department and Research Unit of General Practice My research colleagues have been helpful in constructive discussions, in practical matters of all kinds I would also like to thank Hans Christian Kjeldsen and Kaare Mai for good company, our discussions in the office on everything else than research The help provided by all the partners in the PhD project, the ADDITION-study, from the County Health Service, the Department of Health Insurance and all the laboratories on the hospitals has been exceptional, as has their aid in data retrieval and assistance in sorting out problems encountered during the study The choice and use of statistical methods for data analysis was, of course, an interesting challenge, and I owe my special thanks to the Department of Biostatistics, Associate Professor, PhD Morten Frydenberg, who has been most helpful and patient with my queries and questions

I appreciate all the help that I
received from the secretaries, Eva Therkildsen and Helle Hjort Pedersen at the Department of General Practice, Karen Wolsing, Ynna Margot Nielsen and Inge Krogh at the ADDITION-study, Elsebeth Schreiber at the Specific Training for General Practice and Birthe Brauneiser and Eva Højmark Pedersen at the Research Unit of General Practice I am greatly thankful for the assistance provided by Bjarne Benner Svendsen, Lars Venge Olesen and Tonni Juul Hansen in relation to designing questionnaires, handling the retrieval of data and the database, solving all technical problems at hand and keeping virus, worms and other creatures out of my computer I acknowledge the linguistic help of Professor Morten Pilegaard in revising the text I owe a dept of gratitude to the Department of General Practice for housing me and for helping me administer the project economy Considerable financial support was essential for the implementation of the study The PhD study is funded by The Danish National Research Foundation for General Practice, the Danish Medical Association Research Fund, the Diabetes Associations foundation for Scientific Research Furthermore the PhD study could not have been carried through
without financial support given to the ADDITION study DK by: The National health service in the counties of Copenhagen, Aarhus, Ringkøbing, Ribe, South Jutland, all in Denmark The Danish National Research Foundation for General Practice, Danish Centre for Evaluation and Health Technology Assessment, The Aarhus University Research Foundation, Novo Nordic Foundation Unrestricted grants from Novo Nordic AS, Novo Nordic Scandinavia AS, ASTRA Denmark, Pfizer Denmark, GlaxoSmithKline Pharma Denmark, SERVIER Denmark A/S, HemoCue Denmark A/S Finally, I am greatly indebted to my family My father has provided eminent support during the study My father has the ability to grasp all aspects of a problem, keep an overview, and yet still focus on how to solve each of the specific problems My mother and sister have kept me going with their loving support and positive attitude My children give me their unconditioned love and make me believe everything is possible in this world My wife, Dorte, has inspired me in many parts of the project phases and I have enjoyed her ultimate confidence in my capabilities I can only hope that I will be able to return this some day Sune Rubak Aarhus, February
2005

Abbreviations
BMI CI CPRno DIRQ DBP DSCAQ F-H F-M GP HbA1c HCCQ HDL C-group Body Mass Index Confidence Interval Civil Personal Registration number Diabetes Illness Representation Questionnaire Diastolic Blood Pressure mmHg Diabetes Self-Care Activities Questionnaire Number of days pr week with hard physical activity example: heavy lifting, aerobics, playing single tennis Number of days pr week with moderate physical activity example: bicycling in moderate tempo, playing double in tennis General Practitioner Haemoglobin A 1c GHb Health Care Climates Questionnaire High Density Lipoproteins mmol/l Control group in the PhD study of general practitioners receiving no formal education or training in Motivational interviewing C-group is used in the chapters 1, 6-10 of this PhD thesis, otherwise abbreviations for study groups have been specified in each of the remaining chapters 2-5 The Intra-Cluster Correlation Coefficient Ischemic Heart Disease Illness Perception Questionnaire Low Density Lipoproteins mmol/l Intervention group in the PhD study of general practitioners trained in Motivational interviewing I-group is used in the chapters 1, 6-10 of this PhD thesis, otherwise
abbreviations for study groups have been specified in each of the remaining chapters 2-5 Oral Glucose Tolerance Test Odds Ratio Personal Models of Diabetes Interview Questionnaire Randomised Controlled Trial Standard Deviation Systolic Blood Pressure mmHg Sum scoring from questionnaire Blood total Cholesterol mmol/l Triglycerid mmol/l Treatment Self-Regulation Questionnaire Type 2 Diabetes Mellitus

ICC IHD IPQ LDL I-group

OGTT OR PMDIQ RCT SD SBP Sum-qst T-Chol Tgly TSRQ T2D

CONTENTS
CHAPTER 1 1 GENERAL INTRODUCTION 2 THE CONCEPT OF MOTIVATIONAL INTERVIEWING 2 DESCRIPTION OF THE CONCEPT OF MOTIVATIONAL INTERVIEWING 2 USE OF MOTIVATIONAL INTERVIEWING IN RESEARCH AND PRACTICE 3 THE ADDITION-STUDY 4 AIM OF PHD THESIS 4 CHAPTER 25 MOTIVATIONAL INTERVIEWING: A SYSTEMATIC REVIEW AND META-ANALYSIS 5 ABSTRACT 6 INTRODUCTION 7 METHODS 8 SEARCH STRATEGY 8 SELECTION 10 QUALITATIVE DATA SYNTHESIS 10 VALIDITY ASSESSMENT, DATA EXTRACTION 11 QUANTITATIVE DATA SYNTHESIS 11 STUDY CHARACTERISTICS 11 RESULTS 11 TRIAL FLOW 11 VALIDITY ASSESSMENT, DATA EXTRACTION 12 QUANTITATIVE DATA SYNTHESIS 14 QUALITATIVE DATA SYNTHESIS 17 STUDY CHARACTERISTICS 17 DISCUSSION 17 MAIN FINDINGS 17 STRENGTH AND
LIMITATIONS 18 DETAILED FINDINGS 18 IMPLICATIONS FOR FUTURE RESEARCH 19 IMPLICATIONS FOR PRACTICE 19 CONCLUSION 19 CHAPTER 321 HOW DOES AN EDUCATION AND TRAINING COURSE IN MOTIVATIONAL INTERVIEWING INFLUENCE GENERAL PRACTITIONERS PROFESSIONAL BEHAVIOUR ADDITION DENMARK 21 ABSTRACT 22 INTRODUCTION 23 METHODS 24 STUDY GROUP 24 METHOD OF INTERVENTION 26 MEASUREMENTS 26 STATISTICAL METHOD 28 RESULTS 28 STUDY SAMPLE CHARACTERISTICS 28

VII

STUDY DATA AND ANALYSES 28 DISCUSSION 31 MAIN FINDINGS 31 STRENGTH AND LIMITATIONS 31 DETAILED FINDINGS 32 IMPLICATIONS FOR FUTURE RESEARCH 32 CONCLUSION 33

CHAPTER 435 EFFECT OF MOTIVATIONAL INTERVIEWING ON BELIEFS AND BEHAVIOUR AMONG PATIENTS WITH TYPE 2 DIABETES DETECTED BY SCREENING ADDITION DENMARK 35 ABSTRACT 36 INTRODUCTION 37 METHODS 38 STUDY GROUP 38 METHOD OF INTERVENTION 40 MEASUREMENTS 40 STATISTICAL METHOD 41 RESULTS 42 DISCUSSION 45 MAIN FINDINGS 45 STRENGTH AND LIMITATIONS 45 DETAILED FINDINGS 46 IMPLICATIONS FOR FUTURE RESEARCH 46 CONCLUSION 47 CHAPTER 549 NO EFFECT OF MOTIVATIONAL INTERVIEW ON RISK PROFILE IN PATIENTS WITH TYPE 2 DIABETES DETECTED BY SCREENING A ONE YEAR FOLLOW-UP OF A RCT ADDITION DENMARK 49 ABSTRACT 50
INTRODUCTION 51 METHOD 51 STUDY GROUP 51 METHOD OF INTERVENTION 53 MEASUREMENTS 53 RISK PROFILE 53 HEALTH CARE SERVICES 54 SELF-REPORTED DATA 54 STATISTICAL METHOD 54 RESULTS 54 DISCUSSION 57 MAIN FINDINGS 57 STRENGTH AND LIMITATIONS 57 DETAILED FINDINGS 58 IMPLICATIONS FOR FUTURE RESEARCH AND PRACTICE 58 CONCLUSION 59

VIII

CHAPTER 661 GENERAL DISCUSSION OF METHODS 61 INTRODUCTION 62 SETTING OF THE STUDY 62 DESIGN 62 CLUSTER RANDOMISED CONTROLLED TRIAL 63 BIAS 63 BLINDING 63 STUDY EVALUATION 64 INTERVENTION 64 MONITORING THE INTERVENTION 64 ADHERENCE TO MOTIVATIONAL INTERVIEWING 65 CHANGING AND SUSTAINING LONG-TERM CHANGE OF PROFESSIONAL BEHAVIOUR 65 MEASURING METHODS 66 GENERAL PRACTITIONER QUESTIONNAIRE 66 PATIENT QUESTIONNAIRE 66 CASE RECORD FORMS 68 BLOOD SAMPLE DATA 68 NATIONAL HEALTH SERVICE REGISTRY DATA 68 STATISTICAL METHODS 69 POTENTIAL GENERALISATION OF OUTCOME 71 CHAPTER 773 GENERAL DISCUSSION OF RESULTS 73 INTRODUCTION 74 DISCUSSION OF RESULTS 74 CONDITION FOR OBTAINING AN EFFECT OF THE TRAINING COURSE IN MOTIVATIONAL INTERVIEWING 74 EFFECT OF MOTIVATIONAL INTERVIEWING ON GENERAL PRACTITIONERS 75 EFFECT OF MOTIVATIONAL INTERVIEWING ON PATIENT BEHAVIOUR CHANGE AND
PATIENT RISK PROFILE 75 CHAPTER 877 CONCLUSION 78 CHAPTER 979 PERSPECTIVES AND IMPLICATIONS FOR FUTURE RESEARCH AND PRACTICE 80 PERSPECTIVES 80 IMPLICATIONS FOR FUTURE RESEARCH 80 IMPLICATIONS FOR PRACTICE 80 CHAPTER 1081 ENGLISH SUMMARY 82 GENERAL INTRODUCTION 82 AIM OF PHD THESIS 82 MOTIVATIONAL INTERVIEWING, A SYSTEMATIC REVIEW AND A META-ANALYSIS ARTICLE 183 HOW DOES AN EDUCATION AND TRAINING COURSE IN MOTIVATIONAL INTERVIEWING INFLUENCE GENERAL PRACTITIONERS PROFESSIONAL BEHAVIOUR ARTICLE 283

EFFECT OF MOTIVATIONAL INTERVIEWING ON BELIEFS AND BEHAVIOUR AMONG PEOPLE WITH TYPE 2 DIABETES DETECTED BY SCREENING ARTICLE 3 83 NO EFFECT OF THE MOTIVATIONAL INTERVIEW ON RISK PROFILE IN PEOPLE WITH TYPE 2 DIABETES DETECTED BY SCREENING A ONE YEAR FOLLOW-UP OF A RCT ARTICLE 484 GENERAL DISCUSSION OF METHODS 84 GENERAL DISCUSSION OF RESULTS 84 CONCLUSION 84 PERSPECTIVES AND IMPLICATIONS FOR FUTURE RESEARCH AND PRACTICE 84

CHAPTER 1185 DANSK RESUMÉ 85 INTRODUKTION 86 FORMÅL MED PHD AFHANDLINGEN 86 DEN MOTIVERENDE SAMTALE, ET SYSTEMATISK REVIEW OG EN META-ANALYSE ARTIKEL 187 HVORDAN PÅVIRKER ET KURSUS I DEN MOTIVERENDE SAMTALE PRAKTISERENDE LÆGERS PROFESSIONELLE ADFÆRD ARTIKEL 2 87
EFFEKTEN AF DEN MOTIVERENDE SAMTALE PÅ SCREENEDE TYPE 2 DIABETES PATIENTERS OVERBEVISNING OG ADFÆRD ARTIKEL 3 87 INGEN EFFEKT AF DEN MOTIVERENDE SAMTALE PÅ SCREENEDE TYPE 2 DIABETES PATIENTERS RISIKO PROFIL EN 1-ÅRS OPFØLGNING AF ET RANDOMISERET KONTROLLERET FORSØG ARTIKEL 4 88 GENEREL DISKUSSION AF METODERNE 88 GENEREL DISKUSSION AF RESULTATER 88 KONKLUSION 88 PERSPEKTIVER OG STUDIETS KONSEKVENSER FOR FREMTIDIG FORSKNING OG PRAKSIS 88 REFERENCES89 APPENDICES103 APPENDIX A FLOWCHART OF THE ADDITION STUDY, OF THE PHD STUDY, AND TABLE 1 APPENDIX B EDUCATIONAL PROGRAMME OF MOTIVATIONAL INTERVIEWING APPENDIX C QUESTIONNAIRES IN DANISH USED IN THE STUDY APPENDIX D CASE RECORD FORMS IN DANISH USED IN THE STUDY

Chapter 1
General introduction

The concept of Motivational interviewing In this thesis Motivational interviewing as a concept is based on the definition of Miller and Rollnick presented in their book Motivational interviewing, preparing people to change addictive behaviour, 2002 1;2 Miller and Rollnick defined Motivational interviewing as a directive, client-centred counselling style for eliciting behaviour change by helping clients to explore and resolve ambivalence The
concept of Motivational interviewing evolved from experience with the treatment of alcoholism and was described by Miller in 1983 3 This early experience developed into a coherent theory and detailed description of clinical procedures was provided in Miller and Rollnick 1991 1, a work which was recently revised 2002 2 Miller and Rollnicks theory also draws inspiration from Carl Rogers work on non-directive counselling and behavioural change theory described in 1951 4 Previous research and the use of the term or concept Motivational interviewing has made it a more comprehensive concept that also often includes aspects from other psychological models of behaviour change and different approaches to the patient-doctor relationship These new conceptual elements border on Motivational interviewing, and some even rest on the same theoretical foundation However, in important respects, they are not coherent with the core concept of Motivational interviewing formulated by Miller and Rollnick Description of the concept of Motivational interviewing Motivational interviewing is based on a characteristic counselling style including different techniques used in the patient-doctor relationship The
examination and resolution of ambivalence is the central purpose in non-directive counselling However, the counsellor is intentionally directive in pursuing this goal Motivational interviewing is a particularly way of helping clients recognize problems and change their behaviour accordingly It is considered particularly useful with patients who are reluctant to change or ambivalent about changing their behaviour The strategies of Motivational interviewing are more persuasive than coercive, more supportive than argumentative, and the overall goal is to increase the clients intrinsic motivation so that change arises from within rather than being imposed from without 2 The spirit and characteristics of Motivational interviewing is captured in the following key points 2 1 Motivation to change is elicited from the client, and not imposed from without Other motivational approaches have emphasised coercion, persuasion, constructive confrontation Such strategies may have their place in evoking change, but they are quite different in spirit from Motivational interviewing which relies upon identifying and mobilising the clients intrinsic values and goals to stimulate behaviour change 2
Ambivalence takes the form of a conflict between two courses of action eg indulgence versus restraint, each of which has perceived benefits and costs associated with it The counsellors task is to facilitate expression of both sides of the ambivalence impasse, and guide the client toward an acceptable resolution that triggers change The specific strategies of Motivational interviewing are designed to elicit, clarify, and resolve ambivalence in a client-centred and respectful counselling atmosphere

3 The counselling style is generally a quiet and eliciting one More aggressive strategies, sometimes guided by a desire to confront client denial, easily slip into pushing clients to make changes for which they are not ready, and therefore will not accommodate afterwards 4 Readiness to change is not a client trait, but a fluctuating product of interpersonal interaction Resistance and denial are seen not as client traits, but as feedback regarding counsellor behaviour Client resistance is often a signal that the counsellor is assuming greater readiness to change than is the case, and it is a cue that the counsellor needs to modify motivational strategies 5 Eliciting and reinforcing the
clients in their motivational behaviour towards problem recognition, concerns, desire, intention, responsibility and ability to change The clients belief in the ability to carry out and succeed achieving a specific goal is essential 6 The therapeutic relationship is more like a partnership or companionship than expert/recipient roles The counsellor respects the clients autonomy and freedom of choice and consequences regarding his or her own behaviour 7 Motivational interviewing is not merely a set of techniques that are applied in treatment of clients It is an interpersonal style, not restricted to formal counselling settings It is a subtle balance of directive and client-centred components shaped by a guiding philosophy and understanding of what triggers change Use of Motivational interviewing in research and practice Motivational interviewing is a counselling style and a method that is both rather well documented and scientifically tested, and it is viewed as a useful intervention strategy for changing behaviour5 It has been used and evaluated internationally especially in the last decade, in relation to the following main areas: 1 addiction alcohol abuse and drug addiction, 2
change in lifestyle smoking cessation, weight-loss, physical activity, asthma and diabetes treatment, and 3 adherence to treatment and to control, encounters of follow-up, counselling meetings Motivational interviewing has been deployed by various health care providers, including psychologist, doctors, nurses, dieticians and midwifes However, current studies have focused on its effect in hospital settings with no or little attention to how the methods could be implemented and applied afterward in the daily clinical work especially in general practice A few studies have been conducted in a clinical setting allowing to continue the process of using Motivational interviewing in daily clinical work after project termination 6-10 This thesis explores the effect of Motivational interviewing in general practice Motivational interviewing has only recently been introduced in Denmark, but its use has been rising over the past years and it has been deployed in different scientific and clinical settings Thus, in 2000 the Danish College of General Practitioners issued an introduction booklet on Motivational interviewing 11, which was mailed to all members of the Danish Medical Association
Furthermore, a Danish book on the subject written by Professor Carl Erik Mabeck was issued in more than 10000 copies 12 and more than 30 residential courses in Motivational interviewing have been conducted by Professor Carl Erik Mabeck since These courses attracted mainly nurses, however, a number of GPs also attended the courses with a view to use the methods in general practice Thus, a significant effort has been made in order to enhance the use of Motivational interviewing in Denmark However, no research on the effect of this effort has so far been attempted

The ADDITION-study The ADDITION-study, Anglo-Danish-Ducth study of intensive treatment in people with screendetected diabetes in primary care was developed and implemented in cooperation between the Department of General Practice and the Steno Diabetes Centre The ADDITION-study investigates the effects of screening and intensive treatment, including poly-pharmacological treatment and behaviour change, in patients with Type 2 diabetes in general practice as shown in Figure 1, Appendix A 13 The ADDITION-study includes Type 2 diabetes patients detected by screening treated by a target-driven approach to intensive treatment
including behavioural change and it has a follow-up period of 5 years It is a large-scale study in general practice of a highly prevalent disease The ADDITION-study is an ongoing study encompassing three countries, The Netherlands, England and Denmark In Denmark, the study is represented in five counties, Aarhus, Copenhagen, Ringkoebing, Ribe and South Jutland counties In this thesis effect of Motivational interviewing was evaluated in a cluster-randomised controlled trial carried out in the counties of Aarhus and Copenhagen, Denmark, 2001 This PhD thesis is a part of the ADDITION-study It specifically explores the effect after one year of Motivational interviewing on newly diagnosed Type 2 diabetes patients detected by screening This thesis focuses on whether GPs using Motivational interviewing can increase adherence to and effect of intensive treatment of Type 2 diabetes patients risk profile, thus reaching treatment goals Aim of PhD thesis The overall aim of this PhD thesis was to evaluate the effect of a course in Motivational interviewing on intensive treatment of Type 2 diabetes patients detected by screening in general practice Furthermore, the PhD study aimed at evaluating:
1 The effectiveness of Motivational Interviewing as an intervention tool in previous randomised controlled clinical trials RCT and to identify factors shaping outcomes in the areas reviewed 2 In which way a 1-day course in Motivational interviewing and subsequent follow-up meetings influenced the GPs professional behaviour 3 If the GPs having participated in a course in Motivational interviewing found the method applicable and useful in general practice 4 If Motivational Interviewing in general practice can improve patients a contemplation and readiness to change behaviour, b their actual change in patient behaviour, and c their beliefs about Type 2 diabetes treatment 5 If a course in Motivational interviewing for GPs can improve the risk profile of Type 2 diabetes patients detected by screening

Chapter 2
Motivational interviewing: a systematic review and meta-analysis
Rubak S, Sandbaek A, Lauritzen T, Christensen B British Journal of General Practice Accepted 2004

Abstract
Background: Motivational Interviewing is a well-known, scientifically tested method of client counselling developed by Miller and Rollnick and viewed as a useful intervention strategy in treatment of
lifestyle behaviour and disease Study design: A systematic review and a meta-analysis of randomized controlled trials RTCs using Motivational Interviewing as intervention The aim is to evaluate the effectiveness of Motivational Interviewing in different areas of disease and to identify factors shaping outcomes Methods: A systematic literature search in 16 databases produced after selection criteria 72 RCTs, the first published in 1991 A quality assessment was made with a validated scale A meta-analysis was performed as a generic inverse variance meta-analysis Results: Meta-analysis showed significant effect 95 CI of Motivational Interviewing for combined effect estimates for Body Mass Index BMI, total serum-cholesterol, systolic blood pressure, blood alcohol concentration, standard ethanol content, while combined effect estimates for cigarettes per day and for HbA1c were non-significant Motivational Interviewing had significant and clinically relevant effect in app 3 out of 4 studies with equal effect on biological 72 and psychological diseases 75 Psychologists and medical doctors obtained an effect in app 80 of the studies, while other health care providers obtained an effect in
46 of the studies When using Motivational Interviewing in brief encounters of 15 min, 64 of the studies showed effect More than one encounter with the patient ensures effect of Motivational Interviewing Conclusion: We conclude that Motivational Interviewing in a scientific setting outperforms traditional advice giving in the treatment of a broad range of behavioural problems and diseases We now need large scale studies to prove, that Motivational Interviewing can be implemented into daily clinical work in primary and secondary health care

Introduction
The concept of Motivational Interviewing evolved from experience with treatment of alcoholism, and was first described by Miller in 1983 3 This basic experience was developed into a coherent theory and detailed description of clinical procedures is provided by Miller and Rollnick 1991 1, who defined Motivational Interviewing as a directive, client-centred counselling style for eliciting behaviour change by helping clients to explore and resolve ambivalence Miller and Rollnicks theory also draws inspiration from Carl Rogers work on non-directive counselling described in 1953 4 The examination and resolution of ambivalence is the
central purpose in nondirective counselling, and the counsellor is intentionally directive in pursuing this goal Motivational Interviewing is a particular way of helping clients recognize and do something about their present or potential problems It is viewed as particularly useful with clients who are reluctant to change or ambivalent about changing their behaviour The strategies of Motivational Interviewing are more persuasive than coercive, more supportive than argumentative, and the overall goal is to increase the clients intrinsic motivation so that change arises from within rather than being imposed from without2 The spirit of Motivational Interviewing is captured in the key points in Appendix 1 2
Appendix 1 Miller Rollnick: Characteristics of the motivational interviewing 1 Motivational Interviewing relies upon identifying and mobilizing the clients intrinsic values and goals to stimulate behaviour change 2 Motivation to change is elicited from the client and not imposed from without 3 Motivational Interviewing are designed to elicit, clarify, and resolve ambivalence to perceive benefits and costs associated with it 4 Readiness to change is not a client trait, but a
fluctuating product of interpersonal interaction 5 Resistance and denial is often a signal to modify motivational strategies 6 Eliciting and reinforcing the clients belief in ability to carry out and succeed in achieving a specific goal is essential 7 The therapeutic relationship is a partnership with respect of client autonomy 8 Motivational Interviewing is both a set of techniques and counselling style 9 Motivational Interviewing is directive and client-centred counselling understanding and eliciting behaviour change

Motivational Interviewing is broadly applicable in the management of diseases which to some extent is associated with behaviour 6-77 It has been used and evaluated in relation to alcohol abuse, addiction to drugs, smoking cessation, weight-loss, adherence to treatment and follow-up, increase of physical activity, asthma treatment and diabetes treatment, Motivational Interviewing has been deployed by various health care providers, including, among others, psychologist, doctors, nurses and midwifes6;8;30;38;54;62 This review provides an overview of the areas in which Motivational Interviewing has been applied The aim of this review is to evaluate the effectiveness of
Motivational Interviewing as an intervention tool in randomised controlled clinical trials RCT and to identify factors shaping outcomes in the areas reviewed

Methods
Search strategy The following electronic libraries were searched according to the Cochrane Collaborations search strategy for randomised controlled trials for each database: the Cochrane Central Register of Controlled Trials on the Cochrane Library issue 4, 2002; MEDLINE 1966 to January, 2004; EMBASE 1974 to January, 2004; and PsychINFO, including PsychLIT 1967 to January, 2004, Cancerlit 1966 to January, 2004, Science Direct/ISI, including scisearch and social scisearch 1972 to January, 2004, Sociological abstracts 1963 to January, 2004, social services abstracts 1980 to January, 2004, EBSCO net research databases 1980 to January, 2004, CSA/Econ lit index 1969 to January, 2004, Biological science 1982 to January, 2004, Biological abstracts 1969 to January, 2004, AIDS and cancer research abstracts 1982 to January, 2004, AskERIC 1966 to January, 2004, BIOSIS PREVIEWS 1969 to January, 2004, ABI-/INFORM 1971 to January, 2004 The following search terms were used for MEDLINE and adapted for each other database:
motivational interviewing, motivational behaviour, behaviour/motivational interviewing, Behaviour change, Motivational change and Behaviour change/motivational interviewing The proceedings of conferences during 1997 to 2004 on diabetes American Diabetes Association, Diabetes UK [formerly British Diabetic Association], European Association for the Study of Diabetes, International Diabetes Federation were searched under psychological, educational, or behavioural headings for reports of any trials using motivational interviewing The reference lists of included studies and reviews were searched for additional studies If an included trial did not supply sufficient data needed for the meta-analysis, we tried to obtain data approaching the authors and the same time asking for data from unpublished trials The search process was performed by first author Figure 1 shows the progress of RCTs through the review

Figure 1 Flowchart of progress of RTCs in the review

Potentially relevant studies based on key-word search in 16 databases N 15516

Studies excluded because of not being RCT N 15174

RCTs retrieved for more detailed evaluation N 342

Studies excluded because of overlap of
publications between databases N 188

Potentially appropriate RCTs to be included in the review N 154

Studies excluded because of intervention not being based on Miller Rollnick N 88

RCTs included in the review N 72

RCTs included in the review with direct effect measures N 42

RCTs included in the review with direct objective measures and statistical data entering the Meta-analysis N 19

Selection In Figure 2, a Funnel plot is presented 82 RCTs included in the review were using Motivational Interviewing defined according to Miller Rollnick as intervention 2 regardless of the context of client counselling Excluded were RCTs in which there were no or minimal description of the methods of Motivational Interviewing and the modes of delivery We only included studies where traditional advice giving used to help and advice clients served as control Traditional advice giving is used as an expression for doctorcentred approach, ie the GP define the patients problem from a biomedical perspective and does not at all include the patient perspective on the matter, thus giving advice accordingly 12;83 Figur 2 Funnelplot of RCTs using motivational interviewing as
intervention
1000

800

600

400

Sample size n

200

0 -2 -1 0 1 2 3

LogEffect-estimat
A Funnel plot is a simple scatter plot of the treatment effects estimated from individual studies on the x axis against some measure of each studys simple size on the y axis A logarithmic scale ensures that effects of the same magnitude but opposite directions are equidistant In the absence of bias the Funnel plot should resemble a symmetrical inverted funnel or a triangle

Qualitative data synthesis Quality assessment of each of the resulting 72 RCT was assessed by the first author Quality assessment was made with a validated scale 84;85 and individual components known to affect estimates of intervention efficacy 86 The scale consisted of three items pertaining description of randomisation, masking, dropouts and withdrawals in the report of an RCT The scale ranged from 0 to 5, with higher score indicating better reporting The individual components assessed the adequacy of reporting of randomisation, allocation concealment and double-blinding High-quality trials scored minimum of 2 out of 5 86

Validity assessment, Data extraction The abstracts of studies identified by electronic searches
was assessed by first author and extracted onto a data extraction form Confirmation of outcome measures and clinically relevant goals was assessed by all the authors All studies were examined to assess the clinical relevance of their goals and outcome measures to client treatment, for example HbA1c as outcome-measure and study goal as a 1 reduction in HbA1c Table 1 only published in the electronic version of the paper, shows the studies with objective outcome measures and the assessment of clinical relevance and statistical significant effect Furthermore, for a study to be classified as showing effect, the recorded effect had to be statistically significant When a study is classified as demonstrating effect, it therefore enjoys both a statistically significant effect and a clinically relevant effect to client treatment Quantitative data synthesis Statistical data analysis was conducted in SPSS version 110 A descriptive summary of the information extracted from included trials was made The meta-analysis was carried out using Excell 2003 and STATA version 8 The Meta-analysis conforms to the Cochrane Reviewers Handbook 82 The meta-analysis is performed as a generic inverse variance
meta-analysis, in which we assume homogeneity between study estimates The assumption of homogeneity is based on the confidence intervals for the study estimates having large overlap, which indicates homogeneity 82 The meta-analysis calculates combined estimates of effect with standard error and 95 confidence interval The meta-analysis is based on the RCTs which included effect measures on patient outcome and submitted statistical data Study characteristics The following variables were extracted for analysis: 1 Characteristics of the intervention: - Ways of delivery in office, out of patient clinic, at home, by telephone, etc - Duration of intervention time used in one counsellor-client encounter - Number of intervention encounters counselling encounter - Practising counsellor psychologist, doctor, nurse, midwife, etc 2 Design of study study group and follow-up: - Number of participants - Follow-up period - Inclusion criteria population, selection, etc 3 Area of intervention: - Adherence to treatment of diseases - Adherence to life style changes 2 Outcome measures: - Direct indicators health outcome, eg B-glucose, B-cholesterol, utilization of health care services, eg length of
hospital stay, etc - Indirect indicators subjective report, self-assessment, questionnaires

Results
Trial flow The systematic review using RCTs progressed as shown in flowchart, Figure 1

Validity assessment, Data extraction Table 1 only published in the electronic version of the paper, shows studies with objective outcome measures, clinical relevance, statistically significance and published statistical data
Reference no 14 15 17 18 19 20 21 22 6 23 24 25 27 29 30 32 34 35 Objective outcome measure Is the effect of the outcome measure evaluated as clinical relevant Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Do the article conclude the effect statistically significant, 95CI Yes Yes Yes No Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes Yes No Yes Do the article show sufficient statistical data ie mean, SD, SE Yes No No No Yes Yes No No Yes No No No Yes No No Yes No Yes

B-glc/HbA1c: Interventionsgr fall: 11,75-11,02 controlgr Fall: 10,82-10,78 B-gammaGT mean 190 fall to 30 in groups HIV pos/neg do behaviour correlate to status as HIV positive og HIV negative HIV pos/neg do behaviour correlate to status as HIV positive og HIV negative Peak BAC blood
alcohol concentration 140 fall to 90 Nicotine test 10 ng/ml smoking or not B-cholesterol fall 3,5mg/dL B-alkohol mg/dL, 168 fall to 149 B-chol fall 9,5-8,6 mg/dL, diet-cholesterol fall 183-157 mg/1000kcal Length of stay, 47 to 21 fall in hospitalized days for psychiatric patients Moderate physical activity using a minimum of 57,5kcal/min, BMI fall U-cocain-test post/neg drug addiction or not U-cocain-test post/neg drug addiction or not Number of encounters sustained with the patient as a measure of adherence Nicotine test 10 ng/ml smoking or not U-cocain-test post/neg drug addiction or not Number of encounters sustained with the patient as a measure of adherence Fall BMI:27-26, Total cholesterol:7-6, Energy intake 1900kcal/day -1650 kcal/day, fat intake: 70 g/day-17g/day

Table 1 continued Reference Objective outcome measure no 37 38 HbA1c fall 10,8-9,8, weight loss 6 kg, BMI fall 34,7-30 Systolic BP 140-134, diastolic BP 80-75, weight loss 2 kg, alcohol intake fall 170g/day BAC, SEC BAC, SEC BMI: -0,5, weight: -0,5kg, systolic BP fall -3 units, HbA1c 9,8-8,8 Weight loss -2,5 kg, totalchol-fall 0,1mM3,8mg/dL, LDL fall 0,1mM, FFA fall 0,15mM, BMI fall 1,5 kg/m2
Number of admissions for drug addicts SEC SEC standard ethanol content fall 23-12, Peak BAC blood alcohol conc fall 75-56 Fall in metadon dosis in mg Number of admissions for drug addicts Number of admissions for drug addicts Weight-loss, BMI Fall in peak BAC blood alcohol conc SEC Cost-benefit-analysis, admissions, referrals, out of clinic patients HbA1c fall 7,4-6,9, BMI fall -0,5 Compliance towards taking HIV medication Drinks per drinking day CO-test BAC Drug addiction symptoms BAC, SEC Length of hospital stay, treatment participation

Is the effect of the outcome measure evaluated as clinical relevant Yes Yes

Do the article conclude the effect statistically significant, 95CI Yes Yes

Do the article show sufficient statistical data ie mean, SD, SE Yes Yes

41 42 43 45

Yes Yes Yes Yes

Yes Yes No Yes

Yes Yes Yes Yes

46 47 48 50 8 51 52 55 57 9 65 70 71 72 77 78 80 81

Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes Yes No Yes Yes

Yes Yes Yes Yes Yes Yes No Yes Yes Yes Yes No No Yes Yes No Yes No

No Yes Yes No No No Yes No Yes No Yes No No No No No Yes No

Quantitative data synthesis A systematic literature search produced 72 RCT studies, the first published
in 1991, assessing the effectiveness of Motivational Interviewing in client counselling A summary of the results are shown in Table 2 Table 2 Study data N72
Effect Ways of delivery and duration of encounter Minuts, N70 Individual interview, 10-20 Individual interview, 30-45 Individual interview, 60 Individual interview, 60-120 Group Telephone Number of encounters, N71 1 2 3 4 5 5 Counsellor profession, N76 Psychologist Doctor Other health care provider nurse, midwife, dietician Intervention period Month , N71 3 3-5 6-11 12 12-24 24 Measuring method, N116 Direct biological/clinical measures eg HbA1c Direct utilization of health care services eg no of encounters at GP Indirect measures eg questionnaire Area of intervention N72 Diabetes /asthma Smoking cessation Weight-loss / physical activity Alcohol abuse Psychiatrics / Addiction Yes 7 12 26 4 3 0 Yes 10 12 5 8 3 13 Yes 33 19 5 Yes 4 8 10 16 5 5 Yes 25 8 53 Yes 2 8 8 23 12 No 4 5 6 2 0 1 No 15 0 1 2 0 2 No 9 4 6 No 11 3 3 3 3 0 No 8 3 19 No 1 4 2 5 7

Ways of delivery and duration of intervention N70, 2 studies only described the intervention as an individual interview without describing an accurate length of the interview Number of
counselling encounters N71, one study only described the intervention as an individual interview without describing the number of counselling encounters Practising counsellor health care provider, profession N76, 5 studies involved encounters with several counsellors of different educational background, which is why the total number exceeds the total number of studies Intervention Follow-up period N71, one study did not describe the follow-up period Measuring method N116, In some studies both direct and indirect measures were used, which is why the total number exceeds the total number of studies

A Funnel-plot, in Figure 2, indicates that publication bias is non-significant 82 The meta-analysis show significant effect 95 CI of motivational interviewing for combined effect estimates for Body Mass Index BMI, total serum-cholesterol, systolic blood pressure, blood alcohol concentration, standard ethanol content, while combined effect estimates for cigarettes per day and for HbA1c are non-significant Table 3 Table 3 Meta-analysis, the motivational interviewing effect
Effect measure BMI HbA1c T-Chol SBT Cig/day BAC SEC n 1140 243 1358 316 190 278 648 Combined effect estimate 0,72
0,43 0,27 4,22 1,32 72,92 14,64 P-Value 95 CI 0,0001 0,33:1,11 0,155 -0,16:1,01 0,0001 0,20:0,34 0,038 0,23:8,99 0,099 -0,25:2,88 0,0001 46,80:99,04 0,0001 13,73:15,55

Combined estimate is statistical significant within 95CI CI Confidence interval, SD Standard deviation, SE Standard error BMI - body mass index, HbA1c GHb, BAC blood alcohol concentration mg, T-Chol total serumcholesterol mmol/l, SEC standard ethanol content standard units, Cigg/day cigarettes per day, SBT systolic blood pressure mmHg

The full version of Table 3 shown below was only published in the electronic version of the journal Table 3 Meta-analysis, the effect of motivational interviewing
Effect Measure/Reference no BMI/35 BMI/37 BMI/43 BMI/45 BMI/52 BMI/65 Combined BMI effect HbA1c /14 HbA1c /37 HbA1c /45 HbA1c /65 Combined HbA1c effect T-Chol/6 T-Chol/45 T-Chol/35 Combined T-Chol effect Cig pr day/20 Cig pr day/27 Cig pr day/32 Combined Cig/day effect SBT/38 SBT/43 Combined SBT effect BAC/19 BAC/41 BAC/42 BAC/80 BAC/38 BAC/48 Combined BAC effect SEC/42 SEC/41 SEC/19 SEC/47 SEC/80 SEC/57 SEC/48 Combined SEC effect n 97 16 147 550 296 34 1140 46 16 147 34 243 334 927 97 1358 40 29 121 190 166 150
316 34 32 28 42 100 42 278 28 32 32 409 42 63 42 648 effect estimat 0,6 4,7 0,48 0,8 0,3 0,46 0,72 0,69 1,0 0,46 0,15 0,43 0,9 0,12 0,02 0,27 1,1 1,9 0,1 1,32 4 4,59 4,22 76,0 41,0 98,8 48,0 164,0 59,9 72,92 52,3 280,5 20,1 15,1 12,0 3,39 16,6 14,64 P-value 0,250 -0,42:1,62 0,063 -0,26:9,66 0,624 -1,43:2,38 0,001 0,32:1,28 0,602 -0,83:1,43 0,836 -3,9:4,82 0,0001 0,33:1,11 0,394 -0,90:2,28 0,370 -1,19:3,19 0,300 -0,41:1,33 0,771 -0,86:1,16 0,155 -0,16:1,01 0,000 0,74:1,06 0,005 0,04:0,20 0,885 -0,25:0,29 0,0001 0,20:0,34 0,737 -5,32:7,52 0,056 -0,05:3,85 0,946 -2,77:2,97 0,099 -0,25:2,88 0,117 -1,00:9,00 0,172 -1,99:11,18 0,038 0,23:8,99 0,001 32,95:119,1 0,384 -51,34:133,3 0,006 28,24:169,4 0,096 -8,56:104,6 0,004 53,5:274,5 0,086 -8,46:128,3 0,0001 46,8:99,04 0,001 22,38:82,22 0,346 -302,6:863,6 0,052 -0,19:40,4 0,000 14,17:16,04 0,120 -3,12:27,12 0,132 -1,03:7,81 0,098 -3,04:36,24 0,0001 13,73:15,55

Combined estimate is statistical significant within 95 CI All effect estimates are positive CI Confidence interval, SD Standard deviation, SE Standard error Sum weight/sum estweight are values from the meta-analysis, where the effect estimates are weighed against number of
participants in each study BMI - Body mass index, HbA1c GHb, BAC Blood alcohol concentration mg, TChol Blood total cholesterol mmol/l, SEC Standard ethanol content standard units, Cigg/day Cigarettes per day, SBT Systolic blood pressure mmHg

Qualitative data synthesis Quality assessment was made with a validated scale ranging from 0 to 5, with higher score indicating better reporting High-quality trials scored a minimum of 2 out of maximum possible score of 5 Out of 72 RCTs, 50 were assessed to 3 points, 21 assessed to 2 points and one RCT was assessed to 1 point Study characteristics An effect of Motivational Interviewing was demonstrated in 74 53/72 of the RCTs With regard to adverse effects of motivational interviewing none of the publications reported any adverse effects nor did they explicitly aim to report this In no studies have Motivational Interviewing shown to be harmful or having any kind of adverse effects A total of 94 68/72 of the RCTs used individual interview Of the remaining four studies, three used group therapy; one study used a telephone interview, but showed no effect The median duration in all the studies of an individual counselling encounter was
estimated to 60 min range: 10-120 min Among the studies using encounters of 60 min, 81 26/32 showed an effect Out of eleven studies using less than 20 min per encounter 64 7/11 showed an effect The likelihood of an effect rose with the number of encounters Hence, an effect was demonstrated in 40 10/25 of studies with one counselling session, but in 87 13/15 of studies with more than five encounters The studies had an estimated median follow-up period of 12 month range: 2 months to 4 years A prolonged follow-up period increased the percentage of studies showing effect Thus, 36 4/11 of studies with a 3-month follow-up period ascertained an effect compared with 81 26/32 among studies allowing a 12month or longer follow-up period Health care providers as counsellor were: psychologists 55 42/76, medical doctors 30 23/76 and other health care providers nurses, midwives, dieticians, etc 15 11/76 Medical doctors obtained an effect of Motivational Interviewing in 83 19/23 of the studies, where psychologists obtained an effect in 79 33/42 of the studies Other health care providers obtained an effect in 46 5/11 of the studies Intervention targeted alcohol abuse, treatment of clients with
psychiatric diagnoses and different aspects of addiction in 47 of 72 studies, and Motivational Interviewing outperformed traditional advice giving in 75 35/47 of these studies Motivational Interviewing targeted biological problems, ie weight loss, lowering of lipid levels, increasing physical activity, diabetes, asthma and smoking cessation in 25 of 72 studies and had an effect in 72 18/25 Smoking cessation studies alone reported an effect in 67 8/12, where studies involving treatment of diabetes, asthma, and weight-related problems reported an effect in 77 10/13 All studies used indirect measures, eg questionnaires 46 33/72 also used direct effect measures health outcome, direct/indirect indicators, utilization of health care services An effect of Motivational Interviewing was obtained in 75 of the studies elicited in terms of direct measures 33/44 and in 74 of the studies elicited in terms of indirect outcome measures 53/72

Discussion
Main findings This review documents that Motivational Interviewing in a scientific setting effectively helps clients change behaviour and that it outperforms traditional advice giving in approx 80 of the studies No studies have reported
Motivational Interviewing to be harmful or having any kind of adverse effects, however no study did explicitly aim to report this

Strength and limitations Publication bias is often a well known problem However a Funnel-plot, Figure 2, of all the studies within the research area of motivational interviewing indicates publication bias to be nonsignificant Furthermore a methodological quality rating 84-86shows that except one study, all the RCTs in this review has a high methodological quality All studies in the meta-analysis demonstrate a positive effect or tendency although not all studies show a significant effect of Motivational Interviewing However the meta-analysis was only performed on the 19 studies out of 42, which stated effect measures on patient outcome and statistical data needed for the meta-analysis in the article or delivered these data afterwards on request Of the remaining 23 studies, 17 concluded significant effect of Motivational Interviewing and 6 showed non-significant effect These remaining studies did not deliver the statistical data in the article or afterwards needed for metaanalysis However, in the light that a vast majority 33 out of 42 of the RCTs
with effect measures on patient outcome, concluded significant effect of Motivational Interviewing, we believe a potential selection bias to be non-significant and the results of the meta-analysis to be valid Detailed findings The meta-analysis shows significant effect of motivational interviewing for combined effect estimates of Body Mass Index BMI, total serum-cholesterol, systolic blood pressure, blood alcohol concentration, standard-ethanol content Table 3 In particularly the magnitude of the decrease of BMI, systolic blood pressure, blood alcohol concentration decrease and standard ethanol content is of clinical relevance and imply that motivational interviewing can and should be used The significant decrease for the combined effect estimate of total serum-cholesterol is of less clinical importance However viewing an effect as clinical important or not, it is imperative to keep in mind that Motivational Interviewing is based on making the patients themselves aware of potential space for change in behaviour resulting in improved health parameters, which means that small changes also may be of interest, if they are the beginning of a changing process for the patient The nature
of changes from the patient is almost always related to both the adherence to prescribed medication and to what changes the patient make in life style However effect of Motivational Interviewing in some problem areas eg weight loss, smoking cessation, is primarily mediated through change of own habits, whereas effect on asthma primarily comes from adherence to prescribed medication This meta-analysis provides evidence of significant effect of motivational interviewing on many different areas of intervention The review has shown that Motivational Interviewing can be effective even in brief encounters of only 15 min and that more than one encounter with the patient increases the likelihood of effect 6; 7;14;15;24;43;44;45;49;51 This review sheds new light on the assumption that the effectiveness of Motivational Interviewing depends upon the counsellors profession The effect was not related to the counsellors educational background as medical doctor or psychologist Hence, there was no statistical significant difference in the percentage of studies obtaining an effect of Motivational Interviewing whether it was performed by psychologists, psychiatrists, physicians or general
practitioners Utilization of Motivational Interviewing probably depends on other aspects like duration and number of client-counsellor encounters However, it would be reasonable to speculate that aspects like training and experience with Motivational Interviewing methods and clientcounsellor relationship also influence the effectiveness, even if this cannot be shown in this review Five studies involved other health workers, eg nurses, midwifes and dieticians as counsellor, and

another six studies partly involved other health workers in the counselling encounter 6;17;18;22;27;30;32;38;62;70;72 Only five of these eleven studies found Motivational Interviewing to be effective 6;30;38;62;72 This may, to some extent, be explained by the design of these studies as most of them reported on the effect of only one encounter, had a follow-up period shorter than three months and began with difficult subjects like HIV-positive addicts changing life style Implications for future research This review underscores the crucial importance of the Motivational Interviewing setting and the study design for obtaining an effect Thus, a follow-up period shorter than three months increases the risk
of failure counselling, probably due to lack of intervention 22; 27;28;32;34;40;65 Another important aspect was the use of indirect measures versus direct measures This review showed that an effect of Motivational Interviewing can be demonstrated by indirect measures like questionnaires but also direct effect measures like blood pressure, blood glucose, weight, length of hospital-stay, etc When it is possible to measure effect by epidemiological as well as clinical direct measures and to capture effect by clinical endpoints, this should be done to ensure the reliability of the results The optimal design would match the specificity and reliability of direct measures with the in-depth qualitative perspective of indirect measures, eg questionnaires Furthermore in the optimal design, it is imperative that future studies make an effort to describe precisely how Motivational Interviewing education is performed and how we use the methods in client counselling, allowing us all to learn more about how to increase and maximise its effect Implications for practice The review shows that Motivational Interviewing has been used in treatment of various life styles and diseases, psychological as
well as biological The review shows that app 75 of the studies do obtain effect no matter biological or psychological disease, which is supported by the meta-analysis We may therefore now argue that Motivational Interviewing is not limited in any way to counselling of a small group of selected clients, but can be used in the treatment of a broader area of diseases which to some extent is influenced by behaviour When viewed in combination with no apparent harmful effect and no reported adverse effects of Motivational Interviewing, it suggests a method with an important potential effect, which patients very well may benefit from

Conclusion
The review and meta-analysis affords the conclusion that Motivational Interviewing in a scientific setting outperforms traditional advice giving in the treatment of a broad range of behavioural problems and diseases However evaluation of exact methods of Motivational Interviewing in a clinical setting is missing We now need large scale studies both RCTs and qualitative studies on how to implement the methods of Motivational Interviewing, to prove, that it can be implemented into daily clinical work for health care providers and yield effect to the
benefit of the patients

Chapter 3
How does an education and training course in Motivational interviewing influence general practitioners professional behaviour ADDITION Denmark
Rubak S, Sandbaek A, Lauritzen T, Borch-Johnsen K, Christensen B British Journal of General Practice Submitted 2004

Abstract
Background: Motivational interviewing has been shown to be broadly usable in the management of behavioural problems and diseases However, data concerning implementation and aspects regarding the use of Motivational interviewing in general practice is missing Aim: To evaluate general practitioners GPs conception of Motivational interviewing in terms of methods, adherence to and aspects of its use in general practice after a course Study design: The study involved three groups of GPs, two of which comprised a RCT concerning intensive treatment of newly diagnosed Type 2 diabetes patients detected by screening These two groups were randomised to a course in Motivational interviewing The study also included a third group of GPs outside the RCT, who had two years previously received a similar course in Motivational interviewing Methods: The intervention consisted of a 1-day
residential course in Motivational interviewing with -day follow-ups, twice during the first year Questionnaire data from GPs were obtained Results: We obtained a 100 response-rate from the GPs in all three groups The GPs trained in Motivational interviewing adhered statistically significantly more to the methods than did the control group More than 95 of the GPs receiving the course stated that they had used the specific methods in general practice Discussion/Conclusion: A course in Motivational interviewing seems to influence GPs professional behaviour Based on self-reported questionnaires, this study shows that the course provided GPs with skills that raised their confidence in using Motivational interviewing for patient treatment GPs found Motivational interviewing to be more effective than traditional advice giving Furthermore, the experienced GPs found that the method was not more time consuming than traditional advice giving

Introduction
The concept of Motivational interviewing evolved from experience with treatment of alcoholics and was described by Miller in 1983 3 The concept was developed into a coherent theory and a detailed description of the clinical procedures
1 Motivational interviewing has been shown to be broadly usable in the management of behavioural problems and diseases 5 Hence, the method has been used and evaluated internationally especially in the last decade in relation to the following main areas 1 Addiction Alcohol abuse and addiction to drugs, 2 Change in lifestyle Smoking cessation, weight-loss, physical activity, asthma and diabetes treatment, and 3 Adherence to treatment and to control, encounters of follow-up, counselling meetings 5 The technique has been deployed by various health care providers, including psychologist, doctors, nurses and midwifes Controlled trials in general practice have shown that it is an effective strategy in the treatment of different diseases 21;24;36;38;43;60;64 However, only very few studies have focused on how to implement and integrate Motivational interviewing in professional behaviour in daily work in general practice 87;88, and they have concluded that this strategy lends itself well to implementation in general practice We found a need for evaluating whether the general practitioners GPs educated and trained in Motivational interviewing actually used and adhered to the methods in their
clinical work The aim of this study was to evaluate 1 how a 1-day course in Motivational interviewing including follow-up meetings influenced GPs professional behaviour, 2 whether GPs after a 1day course found the method to be useful in general practice

Methods
Study group The study included three groups of GPs: Two groups participated in the ADDITION study 13, which is a multi-centre randomised controlled trial of a target-driven approach to intensive treatment of patients with Type 2 diabetes detected by screening All practices registered at the County Health Insurance Registry in Aarhus County were 1 January 2001 invited to meetings about participation in the ADDITION-study In Copenhagen County only practices located in the north and eastern part 7 municipalities were invited, because screening for diabetes had already taken place in the remaining municipalities in the county in connection with the Inter99 study In agreement with the County Health Insurance only 60 GPs were to be included per county at study onset, and primarily practices with more than one GP were included No exclusion criteria for the GPs were applied and included GPs in the ADDITION study were randomised
at practice level into a group giving standard care and an intervention group educated to intensive treatment including lifestyle intervention and poly-pharmacological treatment aiming for rigorous values of blood glucose, blood pressure and lipids in addition to anticoagulation treatment This study included practices/GPs from the intervention group of the ADDITION study These practices/GPs were sub-randomised into: an internal motivational group IM-group comprising GPs receiving a course with education and training in Motivational interviewing and an internal control group IC-group comprising GPs receiving no formal education or training in Motivational interviewing The inclusion of GPs is shown in the flowchart, Figure 1 Randomisation within the ADDITION study was stratified by county Copenhagen and Aarhus and size of practices GPs received education and training free of charge This study included furthermore an external motivational group EM-group This group consisted of GP, who had attended the course in Motivational interviewing two years before the start of the ADDITION study 20 GPs This group was contacted externally to the ADDITION-study and was asked to answer the same
questionnaire as GPs within the ADDITION-study, thus serving as a group of GPs with long-term knowledge of the use of Motivational interviewing GPs in this group attended the training and paid all expenses themselves

Figure 1 Flowchart of included general practitioners GPs and Type 2 diabetes patients T2D Eligible practices willing to participate N 48 including 65 GPs Eligible practices/GPs, who two years previously attended a residential course in Motivational interviewing External Study group EM-group N 20 practices 20 GPs

Randomisation stratified by county Copenhagen and Aarhus and size of practice

Control group IC-group N 27 36 GPs

Intervention group trained in Motivational interviewing IM-group, N 21 29 GPs

GPs received residential course in intensive treatment of Type 2 diabetes GPs received residential course in Motivational interviewing Follow protocol, guidelines, case record forms and patient material Inclusion of patients according to inclusion-/exclusion criteria GPs follow up days, day twice during the first year GPs included with three years follow-up

GPs included with one year follow-up

Control group, IC-group N 25 30 GPs

Intervention group,
IM-group N 21 29 GPs

External group, EM-group N 20 20 GPs

2 practices 6 GPs dropped out after randomisation

IC-group: Internal control group receiving no formal education or training in Motivational interviewing IM-group: Internal motivational group receiving course in Motivational Interviewing EM-group: External motivational group receiving course in Motivational Interviewing

Method of intervention The courses in Motivational interviewing for the GPs in the IM and EM groups were conducted by a single trained teacher, who had conducted several of these courses successfully The teacher is the first author of Motivational interviewing , a manual from the Danish Scientific Society of General Practitioners 2000 89 which together with Motivational interviewing, preparing people to change addictive behaviour 1991 2 constituted the theoretical part of the course curriculum Each course included 6-12 GP participants Each session started with a short introduction to the methods of Motivational Interviewing followed by group discussions and training the methods involving a high level of participation in workshops and role-plays The principal rules of Motivational Interviewing in
relation to the patient-doctor relationship 2 were trained as was the use of the specific skills eg empowerment 90, use of the ambivalence 2, the decisional balance schedule 2, visual analogue scale 2 and stage of change 91 and reflective listening 2 The courses for the GPs in the IM group consisted of a 1-day training sessions with half a day follow-up twice during the first year Two years prior to the start of this study, the GPs in the EM group had participated in a course similar to that given the IM group None of the GPs in either three groups had previously participated in courses in Motivational interviewing All GPs in the RCT IM-/IC group had participated in the same training courses in intensive treatment of Type 2 diabetes patients detected by screening The training course lasted half a day and follow-up was performed as afternoon meetings twice every year During these diabetes training sessions, it was stressed that GPs should act as counsellors for the patients, allowing treatment decisions to be based on a mutual understanding between the patient and the GP Measurements No validated questionnaire was available for evaluating the courses in Motivational interviewing and
the GPs conception of the methods, adherence to the technique and their actual use of Motivational interviewing The construct of the questionnaire was therefore designed based on 1 the theoretical knowledge about Motivational interviewing, 2 the leading authors knowledge from attending the course and 3 knowledge from the teacher and head of the course The content of the questionnaire was divided into themes: GPs reaction in specific patient cases, GPs preferred way of motivating change in patient behaviour and practicability of Motivational interviewing and aspects concerning the GPs use of the technique in their daily clinical work The questionnaire was evaluated and pilot tested by GPs and lay people within and outside the Department of General Practice, University of Aarhus The validation process included ensuring that questions were not to be misunderstood, that questions in total covered the themes while at the same time not overlaying each other and that answering categories was sufficient to discriminate between different answers In order to evaluate the GPs use of Motivational interviewing, the following 4 questions were asked: Q1: What do you do, when the patient obviously
does not follow your advice? Q2: What do you do, when you sense that the patient does not want to follow your advice? Q3: What do you do, when the patients conception of good health and actual life style are inconsistent? Q4: What do you do, when you aim at motivating change in patient behaviour? For Q1-3 the GPs should respond to 9 different possible reactions Figure 2 on a 5-item Likert scale 1full agreement, 5total disagreement With regard to question 4, the GPs should respond to 8 different possible reactions Figure 3 on a 5-item Likert scale indicating how often they used each possibility 1always, 5never The possible reactions for Q1-4 were related to counselling style, using either Motivational interviewing or traditional advice giving

Traditional advice giving is used as an expression for doctor-centred approach, ie the GP define the patients problem from a biomedical perspective and does not at all include the patient perspective on the matter, thus giving advice accordingly 12;83

Figure 2 Questions Q1-3 to evaluate how GPs used MI
Q1: What do you do, when the patient obviously does not follow your advice? Q2: What do you do, when you sense that the patient does not
want to follow your advice? Q3: What do you do, when the patients conception of good health and actual life style are inconsistent? GPs had to respond on a 5-item Likert scale to each of the following possible reactions: Explain the plan of treatment and care once again Explore further the patients abilities and possibilities for solving the problem Explain by arguments why it is important to follow the treatment once again Investigate if the patient believes that the treatment will help Make the patient tell about advantages and disadvantages of habits in relation to disease Inform further about the disease and treatment to pursuit the patient to a deal Tell further about the consequences if the treatment plan is not followed Make the patient summarize the agreed deal Ask about the patients expectations to what you can do in the actual situation of disease 5-item Likert scale: Fully agree1, partly agree2, not agree or disagree3, partly disagree4, totally disagree5

Figure 3 Questions Q4 to evaluate how GPs used MI
Q4: What do you do, when you aim at motivating change in patient behaviour? GPs had to respond on a 5-item Likert scale to each of following possible reactions:
Reflective listening Preparing the patient of different treatment options before choosing the one Using accurate arguments for change of life-style to emphasize the consequences of sustained life-style Clarifying the treatment strategy in relation to time Emphasizing the patients resources Clarify what advantaged and disadvantages the patient sees in relation to disease and plan of treatment Showing patient empathy, support and respect Focusing on the positive sides of the patients habits in relation to the disease 5-item Likert scale: Always1, Often2, On occasion3, Seldom4, Never5

The sum-scores for questions 1 to 4 were calculated to evaluate whether or not the GPs used the methods of Motivational interviewing or traditional advice giving Questions 1-4 were based on the responses to each possible reaction in Figure 2 and 3 The responses were first reversed in order to unify the direction of the response to each possible reaction Then all the responses to the possible reactions to each question were added and divided by the number of items, thereby generating a mean response for each question The method of sum-scoring questions has been used and validated in different
settings 92-96 Questions 1-4 were given to all three groups of GPs, whereas the remaining questions regarding the practicability of Motivational interviewing and aspects concerning the GPs use of the technique in their daily clinical work Tables 1-3 were given to the GPs in the motivational groups IM-/EMgroup Questionnaires were mailed to all three groups either one year IM- and IC-groups or threes years EM-group after the courses Reminders were mailed two weeks later Statistical method Statistical analysis of data was conducted in SPSS version 110 All single variables containing data from a Likert scale were analysed by a non-parametric Mann Whitney test Tables 2 and 3 All sum-score variables from questions 1-4 followed a normal distribution and consequently a Ttest was done Results are either given as median and quartiles, simple percentages or as mean with 95 confidence interval CI A statistical significance level of 005 two tailed was used

Results
Study sample characteristics A flowchart for participating practices and GPs is shown in Figure 1 In all, 48 practices 65 GPs were included Twenty-syven practices 36 GPs were randomised into the IM-group and 21 practices 29 GPs into
the IC-group Two practices including 6 GPs all in control group dropped out after randomisation We obtained a 100 response rate to the questionnaire from the GPs in all three groups All GPs in the IM- and EM-group participated in the Motivational interviewing courses, and less than 10 were absent from the -day follow-up meetings The GPs had an average age of 53 years, were male in 2 out of 3, and had an average of 1500 patients in their practice with no significant differences between the study groups Study data and analyses The motivational groups IM-/EM-group seemed to adhere more to Motivational interviewing than the control group IC-group as there were no significant differences between these two groups, as opposed to between the motivational groups and the control group in terms of the GPs responses to different doctor-patient situations Table 1

Table 1 GPs counselling according to the methods of Motivational interviewing
Evaluation by mean sum-scores from the possible reactions Tables 1 and 2 to the following questions: Q1: What do you do, when the patient obviously does not follow your advice? Q2: What do you do, when you sense that the patient does not want to follow
your advice? Q3: What do you do, when the patients conception of good health and actual life style are inconsistent? Q4: What do you do, when you aim at motivating change in patient behaviour? IC-group N31 Mean sum-score 293 292 282 193 IM-gr mean N27 Mean sum-score 205 210 208 169 ME-gr mean N20 Mean sum-score 204 214 223 165 P value 95 CI IC vs M 0001 056;121 0001 049;115 0001 040;106 0005 009;044 P-value 95 CI IC vs EM 0001 039;113 0001 041;103 0022 007;074 0026 004;056 P-value 95 CI M vs EM 059 -021;035 094 -031;034 040 -048;020 088 -023;027

Q1 Q2 Q3 Q4

Questionnaire scaling: 1-5, 1 acting according to the methods of motivational interviewing and 5 acting according to traditional advice giving The doctor decides what is best for the patient

The responses from GPs in the control group to the possibilities raised in Figures 2 and 3 showed that they used some elements from both strategies, vizMotivational interviewing and using traditional advice giving A majority 79-100 of GPs in the motivational groups IM-/EMgroup stated that they had used the different elements of Motivational interviewing after the course Table 2 The GPs in the IM-group agreed statistically significantly
more than the GPs in EM-group in the usability of the visual analogue scale and the decisional balance schedule, whereas no differences were seen concerning the usability of the other elements Table 2 Table 2 GPs use of specific methods of Motivational Interviewing one year IM-group and three years EM-group after a course in Motivational Interviewing
Group Method : IM-group N27 GP have used the specific method EM-group N20 GP have used the specific method IM-group N27 GP agrees that method is usable Median 25/75 quartile 1 1;2 1 1;1 2 1;2 2 1;2 1 1;2 1 1;2 EM-group N20 GP agrees that method is usable Median 25/75 quartile 2 1;2 1 1;1 2 175;3 2 1;2 15 1;3 1 1;3 1 1;2 P-value IM-EM

PEARLS @ 81 95 Reflective listening 100 100 Visual analog scale 92 84 Stage of change 81 79 Balance schedule 100 90 Showing and using 85 79 the ambivalence Empowering 96 100 1 1;1 Questionnaire scaling: 1-5, 1 Yes, fully agree and 5 No, disagree @ Partnership-Empathy-Accept-Respect-Legitimate-Support PEARLS ns non-statistical significant difference P 005

ns ns P005 ns P005 ns ns

Fourteen questions addressed the GPs opinion of the course and aspects regarding actual use of the technique Table
3 Four statistically significant differences appeared between the IM- and EMgroup The GPs in IM-group agreed less than GPs in the EM-group to the claim, that it was possible to change working methods and habits by means of Motivational interviewing possibility 9, Table 3 The GPs in EM-group disagreed more than GPs in the IM-group in their awareness to questions concerning aspects of the use of Motivational interviewing possibilities 12-14, Table 3 Table 3 What is your opinion about the methods of Motivational interviewing?
Questions IM-group, N27 Median 25;75 quartiles 2 1;2 2 1;2 1 1;2 2 1;2 3 2;5 1 1;2 5 4;5 2 1;2 4 2;4 2 1;2 1 1;2 EM-group, N20 Median 25;75 quartiles 2 1;2 2 1;2 1 1;2 2 1;2 4 225;4 1 1;2 5 4;5 15 1;2 5 4;5 1 1;2 2 1;2 IM vs EM group P-value ns ns ns ns ns ns ns ns P005 ns ns

1 Did you get the principal rules of motivational interviewing from the residential course? 2 Did you feel trained adequately to use motivational interviewing in daily work? 3 Are the methods of motivational interviewing realistic and usable in daily work? 4 They are very suitable for GP 5 They are suitable to some patients 6 They are more effective than traditional advice giving 7 I have
not yet had patients suitable for the motivational interview 8 Motivational interviewing is an improvement of my working-methods in the patient-doctor relationship 9 I cannot change my working methods and habits by using motivational interviewing 10 It is an advantage to change workingmethods to motivational interviewing 11 The methods of motivational interviewing from the residential course helps me in my patient care and my patient-doctor relationship 12 The methods are time-consuming 13 Patients wants the doctor to tell what must be done 14 It is difficult to change my ways in patient-doctor relationship

3 2;4 3 2;4 2 2;3

5 325;5 5 4;5 4 3;5

P005 P005 P005

1 Questionnaire scaling: 1-5, 1 Yes, fully agree and 5 No, disagree ns non-statistical significant difference P 005

Discussion
Main findings According to the GPs, a course in Motivational interviewing provide them with skills that gave them more confidence in using this method for patient treatment Their professional behaviour in daily practice seemed to be changed in direction of the Motivational interviewing Strength and limitations The main strengths of the study are that 1 all GPs responded to the
questionnaire, 2 all GPs in the IM-group attended the Motivational interviewing courses, and 3 less than 10 GPs were absent from the follow-up meetings In spite of the relatively small number of GPs in each group 20 to 31, significant findings between groups were found Previous studies on Motivational interviewing in general practice have proven an effect 21;24;36;38;43;60;64 However, only few studies have focused on how to implement Motivational interviewing in the daily clinical work in general practice in such a way that it is ascertained that the method is used after study closure 87;88 They concluded that it despite barriers was possible to implement the use Motivational interviewing in general practice 87;88 We used questionnaires as measuring method on effect of a course in Motivational interviewing of GPs in general practice and obtained statistically significant changes between study groups However, the sensitivity of this measuring method is low, when focusing on the GPs actual use and adherence to Motivational interviewing In order to enhance sensitivity of these aspects, external assessment was required, eg video-recordings This was not possible in this study of 48
practices, and 65 general practitioners in two counties The GPs in the internal groups IM-/IC-group were randomised into a RCT arm for Motivational interviewing, whereas GPs in the EM-group had decided by themselves to participate in the course Thus the GPs in the latter group were probably more motivated to obtain and use Motivational interviewing than the former groups However, both motivational groups IM-/EMgroup rated Motivational interviewing the same way except that external group agreed more to the usefulness and the effect of Motivational interviewing in general practice The study suffer the limitation that GPs in the control group could have become familiar with Motivational interviewing by personal initiative during the study period Furthermore, GPs in the RCT IM-/IC-group received training in intensive treatment of Type 2 patients During these diabetes training sessions, it was stressed that GPs should act as counsellors giving patients advice about how to reduce the risk of late diabetic complications and allow treatment decisions to be based on mutual understanding between the patient and the GP This may have influenced the GPs in the control group, who in their
response to the possibilities in Figures 2 and 3 indicated that they neither entirely used Motivational interviewing or the traditional advice giving However, some of their choices showed a tendency for adhering to Motivational interviewing These circumstances tend to reduce the differences between GPs in the IM-group and IC-group In spite of this, statistically significant differences were found This indicates that the course in Motivational interviewing affected the GPs professional behaviour, thus, a relevant change for daily work in general practice The intervention consisted of a course in Motivational interviewing conducted by one person Outcome is therefore highly dependent on this persons teaching methods and capacity to train the

GPs If several teachers had conducted the courses, this problem would have been diminished The use of more teachers on different courses, however, might have introduced differences in learning and training outcome We chose to use one teacher only because only very few can teach Motivational interviewing in Denmark and the teacher had previously conducted several of these courses and was the leading author to the course curriculum Detailed
findings Of particularly interest was that the EM-group of GPs with three years of experience with Motivational interviewing differed more in their evaluation of the usability of some of the specific methods than the IM-group of GPs with one year of experience GPs in the IM-group evaluated methods like visual analogue scale and decisional balance schedule to be more usable in general practice than GPs in the EM-group both methods being straight forward and easy to use The GPs in the EM-group showed a tendency of rating using the ambivalence and empowering higher than the GPs in the IM-group These methods demand that the GP is able to use the principal rules of Motivational interviewing in all aspects Hence, it seems if GPs in the EM-group integrated Motivational interviewing in their patient-doctor relationship to a greater extent than GPs in the IM-group, thus, having obtained more confidence in using its more complex dimensions Even though the GPs in the IM group were recruited by randomisation, their responses mirrored those of the GPs who participated by own choice EM group The results after 3 years in the IMgroup would probably be close to the present results of the EM-group
This is further supported by the fact that both groups evaluated Motivational interviewing as suitable for general practice However, the more experienced GPs in the EM-group expressed that the method was not more time consuming than traditional advice giving The time-consuming aspect of Motivational interviewing has previously been investigated by Rollnick et al in relation to smoking cessation reporting that an average consultation encounter lasted 9-10 min, which was acceptable to the GPs 36 Furthermore, the GPs in the EM-group found the method was not difficult to adapt and use in patient-doctor relationship The motivational groups found that Motivational interviewing improved the patient-doctor relationship and that it was more effective than traditional advice giving Stott et al performed a study on how GPs would react to new technologies and methods showing that GPs did adopt, accept and use new methods when they facilitated solutions to problems in patient-doctor relationship 97 The difference between the motivational groups could indicate that it takes more than one year to integrate Motivational interviewing into daily clinical practice Implications for future research
Doherty et al wrote addressed the relevance of developing GPs skills through Motivational interviewing and the importance of acknowledging the difficulties of changing professional behaviour 98 This study has focused on the first level towards implementing Motivational interviewing, viz to change the way GPs are integrating Motivational interviewing into their daily work Further research into the precise use of Motivational interviewing by GPs is required in order to identify which methods are most effective and why Another aspect to be addressed is whether and how the use of Motivational interviewing affects the patients attitudes toward changing behaviour, eg life style and adherence Finally future research should explore the effect on patient risk profile The ADDITION-study 13is an ongoing

study which aims to gather all these issues into a RCT to evaluate whether a course in Motivational interviewing change the professional behaviour of GPs, whether patients change behaviour and if this improve the risk profile

Conclusion
A Motivational interviewing course seems to influence GPs professional behaviour GPs find that the course provide them with skills that afford them
greater confidence in using Motivational interviewing for patient treatment GPs found that Motivational interviewing was more effective than traditional advice giving and that it improved the patient-doctor relationship Furthermore, the experienced GPs used more complex parts of Motivational interviewing and found that the methods was not more time-consuming than traditional advice giving Whether Motivational interviewing results in a better prognosis for patients remains to be proved

Chapter 4
Effect of Motivational interviewing on beliefs and behaviour among patients with Type 2 diabetes detected by screening ADDITION Denmark
Rubak S, Sandbaek A, Lauritzen T, Borch-Johnsen K, Christensen B

Abstract
Background: Motivational interviewing has been shown to be broadly applicable in the management of behavioural problems and diseases associated with unhealthy lifestyle Only few studies have evaluated the effect of Motivational interviewing on the treatment of Type 2 diabetes and none have explored the effect of Motivational interviewing on target-driven intensive treatment of this disease Aim: To evaluate whether Motivational interviewing in general practice improves
screened Type 2 diabetes patients beliefs about Type 2 diabetes and its consequences, and whether it changes their behaviour Study design: Two groups of GPs were randomised to training in Motivational interviewing or not Both groups received training in target-driven intensive treatment of Type 2 diabetics Methods: The intervention consisted of a 1-day residential course in Motivational interviewing with -day follow-ups twice during the first year Data from patients was obtained using previously validated questionnaires Results: The study obtained 87 response rate Patients in the intervention group were statistically significantly more autonomous and motivated in their inclination to change behaviour compared to patients from the control group after one year Patients in intervention group were also statistically significantly more conscious of the importance of controlling their diabetes and had a significantly better understanding of the possibility of preventing complications However the significant differences between the groups were small Discussion/Conclusion: Questionnaires one year showed that Motivational interviewing had improved on patient beliefs of Type 2 diabetes
treatment and their contemplation and readiness to behaviour change No change was seen in self-reported lifestyle behaviour

Introduction
Type 2 diabetes attracts growing attention because of rising prevalence, its accompanying disablement due complications and the reduced life expectancy associated with this disease At the root of this problem lies inexpedient lifestyle behaviour, failure to adhere to intensive treatment and prescribed medication 99-102 Most Type 2 patients are being treated in primary care, but the majority of studies of intensive treatment of patients with Type 2 diabetes have been performed in hospital settings and without the use of Motivational interviewing 99-102 However, there is a growing interest in methods like Motivational interviewing, one of the rather well-known, scientifically tested method of client counselling developed by Miller and Rollnick 2 It is viewed as a useful intervention strategy for changing behaviour and it may be instrumental in improving the prognosis of the disease Motivational interviewing has been used as an intervention strategy in several contexts, eg alcohol abuse, drug addiction, smoking cessation, weight-loss, adherence
to treatment and follow-up, increase of physical activity, asthma treatment and diabetes treatment 5 A previous study showed a course in Motivational interviewing can influence GPs professional behaviour towards using the method in general practice 103 This study, performed in general practice, aims to evaluate whether Motivational interviewing of Type 2 diabetes patients detected by screening can improve their self-reported 1 contemplation and readiness to change behaviour, 2 actual change in patient behaviour, and 3 beliefs regarding Type 2 diabetes

Methods
Study group This study is a sub-study of the ADDITION study 13, which is a multi-centre randomised controlled trial of a target-driven approach to intensive treatment of patients with Type 2 diabetes detected by screening All practices registered at the County Health Insurance Registry in Aarhus County were 1 January 2001 invited to meetings about participation in the ADDITION-study In Copenhagen County only practices located in the north and eastern part 7 municipalities were invited, because screening for diabetes had already taken place in the remaining municipalities in the county in connection with the Inter99 study
In agreement with the County Health Insurance only 60 GPs were to be included per county at study onset, and primarily practices with more than one GP were included No exclusion criteria for the GPs were applied and included GPs were randomised at practice level into a group giving standard care or an intervention group educated to intensive treatment including lifestyle intervention and poly-pharmacy aiming for rigorous values of blood glucose, blood pressure and lipids in addition to anticoagulation treatment This study included practices/GPs from the intervention group of the ADDITION study These practices/GPs were sub-randomised into an intervention group I-group comprising GPs receiving a course with training in Motivational interviewing and a control group C-group comprising GPs receiving no formal training in Motivational interviewing Randomisation was stratified by county Copenhagen and Aarhus and size of practices GPs received training free of charge The inclusion of GPs and patients is shown in the flowchart, Figure 1 Patients were included in the study by the following inclusion-/exclusion criteria: All newly diagnosed Type 2 diabetes patients detected by screening aged
40-69 years were eligible unless they were found to have contraindications or intolerance to study medication; a history of alcoholism, drug abuse, psychosis or other emotional problems that were likely to invalidate informed consent or adherence to treatment; malignant disease with a poor prognosis; or were pregnant or lactating Patients previously diagnosed with diabetes or treated with blood glucose lowering agents were excluded

Figure 1 Flowchart of included general practitioners GPs and screen-detected Type 2 diabetes patients T2D Eligible practices willing to participate N 48 including 65 GPs

Randomisation stratified by county and size of practice

Intervention group, trained in Motivational interviewing I-group, N 21 29 GPs

Control group, C-group N 27 36 GPs

GPs received residential course in intensive treatment of Type 2 diabetes GPs received residential course in Motivational interviewing

Follow protocol, guidelines, case record forms and patient material Inclusion of patients according to inclusion-/exclusion criteria GPs meeting at follow-up days, day twice during the first year GPs included with one year follow-up Intervention group, I-group N 21 29 GPs
Control group, C-group N 25 30 GPs

Patients included with one year follow-up N 137 T2D in I-group N 128 T2D in C-group

Complete questionnaire data after one year follow-up N 119 T2D in I-group N 115 T2D in C-group

2 practices 6 GPs dropped out after randomisation 2 Type 2 diabetes patients dropped out after randomisation

Method of intervention The courses in Motivational interviewing for the GPs in the I-group were conducted by a single trained teacher, who had conducted several of these courses successfully The teacher is the first author of Motivational interviewing , a manual from the Danish Scientific Society of General Practitioners 2000 89 which together with Motivational interviewing, preparing people to change addictive behaviour 1991 2 constituted the theoretical part of the course curriculum Each course included 6-8 GP participants Each session started with a short introduction to the methods of Motivational Interviewing followed by group discussions and training the methods involving a high level of participation in workshops and role-plays The principal rules of Motivational Interviewing in relation to the patient-doctor relationship 2 were trained as
was the use of the specific skills eg empowerment 90, use of the ambivalence 2, the decisional balance schedule 2, visual analogue scale 2 and stage of change 91 and reflective listening 2 The courses for the GPs in the I-group consisted of a 1-day training sessions with a -day followup twice during the first year None of the GPs in I- and C-group had previously participated in a course in Motivational interviewing All GPs in the I- and the C-group had participated in the same training courses in intensive treatment of Type 2 diabetes patients This training course lasted half a day and follow up was performed as afternoon meetings twice every year During these diabetes training sessions, it was stressed that GPs should act as counsellors for the patients, allowing treatment decisions to be based on a mutual understanding between the patient and the GP Measurements The intervention phase began 1 May 2001 and included the 1-year follow-up data The questionnaire used for assessment consisted of a collection of previously validated questionnaires used in primary care and on Type 2 diabetes patients: Health Care Climates Questionnaire HCCQ 104-108 It assesses the patients perceptions of
patient-doctor relationship and the the degree to which counselling are autonomous supportive versus controlling In this study the short 6-item HCCQ was used It includes 7 items using a Likert scale with categories from not at all true to very true Treatment Self-Regulation Questionnaire TSRQ 105;108-110 It assesses the degree to which behaviour tend to be self-determined The main scale includes three subscales: the autonomous regulatory style; the controlled regulatory style; and amotivation style The autonomous style represents the most self-determined form of motivation and has consistently been associated with behaviour change and positive health care outcomes 105 TSRQ is a questionnaire including 21 items It involves a 7-item Likert scale with categories from not at all true to very true Diabetes Illness Representation Questionnaire DIRQ, which comprises two questionnaires, the Illness Perception Questionnaire IPQ and the Personal Models of Diabetes Interview Questionnaire PMDIQ 92;93;111 The DIRQ questionnaire assesses Type 2 diabetes patients beliefs and understanding of Type 2 diabetes and involves 5 subscales: Identity symptoms associated with the illness; cause the cause
of illness and the factors responsible for illness onset; timeline patients perception of duration of the illness; threat, impact ie consequences patients expected outcome of the illness; and prevent/control/treatment/effectiveness patients beliefs about the extent to which

the illness is amenable to cure, in which way prevention is possible and how good recommended treatments are at controlling the illness In this study we only used 4 of the subscales, excluding identity because we obtained this by the GPs reports All questions involve a 5-item Likert scales with categories from no importance to extremely important The DIRQ included 30 items Summary of Diabetes Self-Care Activities SDSCA95;112-116 It assesses to which extent Type 2 diabetes patients perceive advice on various self-care activities related to Type 2 diabetes The questionnaire focuses on which advice from the counsellor has been perceived by the patient in relation to: general diet and specific diet ; exercise; testing and controlling; adherence to prescribed medication; foot care; and smoking The answering categories were either listed on a dichotomous yes/no or a continuous scale viz On how many of the
last 7 days did you ? The SDSCA included 13 items 13 self-constructed and pilot tested questions on self-care activities in relation to smoking, alcohol and exercise Answering categories were dichotomised or presented on a continuous scale

Sum-scores were calculated for the questionnaires HCCQ, TSRQ and DIRQ The sum-scores for questions were calculated to obtain an overall picture of each patients views on different subjects Table 1 and 5 Questionnaire responses for each subject were first reversed in order to unify the direction of the response to each question Then the responses were added and divided by the number of responses to generating a mean response The method of sum-scoring questions has been used and validated in different settings 92;93;95;96;108-111;117 All the questionnaires were translated by the conventional principal rules of forward-backward translation The authors translated from English into Danish and a British subject residing in England speaking Danish translated backward again in order to ensure mutual agreement of the translation After the translation, the final Danish questionnaire was pilot-tested and validated on a group of 5 GPs and a group of
their Type 2 diabetes patients Questionnaires to all patients in both groups of GPs were mailed at baseline and 6 and 12 month after inclusion One reminder was sent in case of no response within four weeks The questionnaires were designed in and read by the computer program Teleform 118, which ensures reliable and valid data 119 Statistical method Statistical analysis of data was conducted in SPSS version 110 All single variables containing data from a Likert scale were analyzed by Non-Parametric Mann Whitney test All sum-score variables followed a normal distribution and consequently a T-test was therefore performed Results are either given as median and quartiles, simple percentages or as mean and 95 confidence interval CI A statistical significance level of 005 two tailed has been used The clustering of GPs was adjusted for by using a mixed regression model assuming random normal variation between and within GPs

Results
A flowchart for participating practices GPs and patients is shown in Figure 1 In all, 48 practices 65 GPs were included Twenty-seven practices 36 GPs were randomised into the I-group and 21 practices 29 GPs into the C-group Two practices 6 GPs and 2 patients
dropped out after randomisation All GPs in the I-group participated in the training courses, and less than 10 were absent from the -day follow-up meetings The study included 265 Type 2 diabetes patients detected by screening with a one year follow-up; 128 in the C-group and 137 in the I-group The response rate to the patient questionnaire was 87 in the I-group and 90 in the C-group Among the 265 patients, 59 were males, average age of 62 years, 33 of patients with familiar history of diabetes, with no significant differences between the study groups The GPs had an average age of 53 years, were male in 2 out of 3, and had an average of 1500 patients in their practice with no significant differences between the study groups The sum-scores for the HCCQ- and TSRQ-questionnaire are presented in Table 1 Table 1 Health Care Climate Questionnairen HCCQ and Treatment Self-Regulation Questionnaire TSRQ evaluated after one year
I-group mean 588 495 646 290 148 C-group mean 569 489 625 343 140 ; 95 CI; P-value 019 -014;052 026 006 -031;043 075 021 001;041 004 -053 -094;-011 0014 008 -008;023 034 Interpretation of results In general, patients in both groups are satisfied with their relationship
with the GP and the counselling style In general, patients in both groups tend to some extent to seek leadership and controlling counselling Patients in the I-group were more autonomous, ie more self-determined and motivated for behavioural change Patients in the C-group were more amotivated, ie not motivated for behavioural change The relative index does not change statistically significantly between groups due to the small magnitude of change in autonomy/control

Sum-score HCCQ sum TSRQ control TSRQ autonomy TSRQ amotivation TSRQ relative autonomicontrol index

Sum-scores of sub-questions-answers on a 7-item Likert scale, 1totally disagree to 7fully agree

Overall, patients in the C- and I-group reported being satisfied with their GP With regard to treatment and self-regulation, both groups wanted controlling counselling TSRQ-control, even when they stayed autonomous in their behaviour decisions TSRQ-autonomy Patients from the I-group were statistically significantly more autonomous in their choice of action towards behavioural changes than patients from C-group after one year Patients from the I-group were statistically significantly more motivated for changing behaviour less
TSRQ-amotivation than patients in the C-group after one year, but not after 6 month

Table 2 features self-reported advice from GPs regarding diet, exercise and self-control of diabetes after one year Patients in the I-group reported having received statistically significantly more specific advice from their GP regarding diet, exercise and self-control of diabetes than patients in the C-group after one year The differences in perceived advice from the GPs became more statistical significant after 12 month compared to 6 months of study period Table 2 Advice giving by the general practitioner to the patient after one year Diabetes Self-Care Activities Questionnaire
Advice given by the GP Follow a low-fat eating plan Follow a complex carbonhydrate diet Reduce the number of calories Eat lots of food high in dietary fibre Eat lots at least 5 servings per day of fruits and vegetables Eat very few sweets eg deserts You have not been given any advice about your diet Get low level exercise such as walking on a daily basis Exercise continuously for a least 20 minutes at least 3 times a week Fit exercise into your daily routine Engage in a specific amount, type, duration and level of
exercise You have not been given any advice about exercise Test your blood glucose sugar using a drop of blood from finger Test your blood glucose using a machine to read the results Test your urine for sugar You have not been given any advice about testing for glucose I-group N137 818 504 708 599 730 671 22 759 314 642 190 36 548 453 271 234 C-group N128 763 336 588 435 618 634 69 748 206 519 69 84 389 290 115 374 I-gr vs C-gr P-value 0025 001 0024 0002 0033 034 079 066 0029 002 0002 061 0034 0006 0002 0029

Self-care activities regarding changing smoking and alcohol habits after one year are shown in Table 3 A group of patients including 16 patients 1,2 in the I-group and 22 patients 1,6 in the C-group had a level of alcohol consumption above the recommended treatment goals Overall there was no significant difference in smoking and alcohol intake suggesting a behavioural change Table 3 Patients self-care activities regarding smoking and alcohol after one year Diabetes Self-Care Activities Questionnaire
Question I-group C-group P-value How many cigarettes do you smoke on average per day? 476 346 035 How many beers do you drink on average per week? 219 424 027 How many
glasses of wine do you drink on average per week? 184 280 024 In consideration to your health, do you believe that you should lower 67 73 027 your alcohol intake? ;n/N 90/137 94/128 At your last doctors visit, did anyone ask about your smoking status? 33 25 008 ;n/N 47/137 32/128 At your last doctors visit, did anyone council you about stopping 22 24 079 smoking or refer you to a stop-smoking program? ;n/N 31/137 31/128 How motivated are you at stopping smoking? 236 248 047 scale: 1 very much, 5 not at all Data regarding smoking was analyzed according only to smokers, whereas data regarding alcohol intake was analyzed on all patients

The DIRQ questionnaire assessed patients self-reported beliefs about the causes of illness, including the factors responsible for its onset with no significantly differences between groups Table 4 shows changes in patients beliefs regarding their diabetes Patients in the C- and I-group showed no significant differences in terms of their opinion about the threat and the impact diabetes imposed on their lives and on the time aspects of their disease Patients in both groups reported controlling their diabetes and paying attention to preventing factors
as important Patients in the Igroup were statistically significantly more aware of the importance of controlling their diabetes for specific factors than patients in the C-group and they also had a statistically significantly better understanding of the probability of how different factors would prevent complication Table 4 Patients views on timeline, control, prevention, threat and impact of diabetes evaluated after one year by the Diabetes Illness Representation Questionnaire
I-group mean 241 390 416 261 350 C-group mean 245 368 399 259 348 ; 95 CI; P-value -004 -023;015 070 022 004;039 0016 017 001;032 0042 002 -009;-012 067 002 -012;018 070

Sum-score Timeline patients perception of duration of the illness Control patients beliefs about how good recommended treatments are at controlling the illness Prevention patients beliefs about the extent to which the illness is amenable to cure and in which way prevention is possible Threat patients expected outcome of the illness Impact patients expected impact on day-today life and in the long term

Sum-scores on a 5-item Likert scale: 1no importance to 5extremely important

Discussion
Main findings After one year, patients in the
I-group became increasingly more autonomous and motivated for behavioural changes than patients in the C-group Furthermore, patients in the I-group were more knowledgeable and had a better understanding of which factors would help prevent complications and ensure relevant disease control The autonomous style represents the most self-determined form of motivation and has consistently been associated with behavioural change and positive health care outcomes 105;108-110 A RCT-study showed that changes in perceptions of autonomy predicted change in glycemic control 108 These findings suggest that Motivational interviewing have moved more patients in the I-group than in the C-group into the contemplation phase and that they increased their readiness to change behaviour Strength and limitations We cluster randomised at practice level in order to avoid contamination between the interventionand control group 120 The cluster design does affect the statistical analysis, because in this design the patients are not independent individuals statistically and the statistical analysis has to be performed using the number of cluster units, thus reducing the total number in the comparing groups
120-122 Cluster randomisation with a small number of units is not likely to show similar distributions of baseline characteristics among groups 123 However, we included 48 practices in 2 counties, which secured similar distributions in each treatment group Furthermore, we performed stratified randomisation of GPs on size of practice and on county We hence anticipate a high internal validity, a low degree of selection bias and a random allocation of unpredictable, immeasurable confounders The study showed that the GPs in the different groups included an equal number of Type 2 diabetes patients, which supports the conclusion that selection bias was limited The number of GPs and patients all in C-group dropped out of the study after randomisation is not expected to bias the results in consideration of the total number of GPs and patients included in this study The study did not include blinding and behavioural changes may therefore be influenced by the Hawthorne effect 124 However in this PhD project both groups of patients were treated with intensive treatment and only one group was further exposed to Motivational interviewing In this way attention to the treatment of Type 2 diabetes
including lifestyle changes would increase in both groups and a potential Hawthorne effect would hence exist in both groups If the patients consciousness about changing lifestyle behaviour was raised because of the Hawthorne effect, this would tend to reduce the effect of Motivational interviewing The validity of the study is strengthened by a high response rate to the questionnaire and the use of sum-scoring, a validated method increasing the power of the statistical analysis The measuring methods used to observe patient behaviour change was mainly based on validated questionnaires which increase the reliability of our results The study may suffer from a limitation because training in Motivational interviewing was only performed by one person This makes outcome highly dependent on this persons teaching methods and capacity to train the GPs 103 This person was, however, highly experienced in the methods of Motivational interviewing and in teaching We evaluated the course and found GPs in the I-group adhered more to the methods of Motivational interviewing than GPs in the C-group 103

In order to ascertain an effect of behavioural intervention, it is necessary to adopt a triple
approach assessing 1 professional behavioural change to Motivational interviewing on the part of the counsellor, 2 patient behavioural change and/or attitudes to entering contemplation phase of behavioural change, and finally 3 effect on patient outcome measures eg risk profile 103 This paper presents the results of the second stage The presentation of the effect measures of patient risk profile of this study awaits publication Detailed findings It was unexpected to find that GPs in I-group gave patients more advice on diet, exercise and selfcontrol of diabetes than GPs in the C-group In a similar trial investigating the effect of patientcentred care on lifestyle, Kinmonth et al reported that patients became more satisfied by their GPs counselling style, however with no effect on perceived advice or the risk profile 125 The authors suggested that that GPs became too focused on the consultation process at the expense of disease management 125 Our interpretation of the results in this paper is that GPs in the I-group used Motivational interviewing to increase the patients awareness of the need for behavioural changes in lifestyle and adherence to diabetes treatment, which led the
patients to believe that they had received more advice and thus integrated the behavioural change to a higher degree than patients in the C-group However, whether this study shows effect on the patients risk profile remains to be seen GPs in both groups managed to educate the patients to the same level of knowledge about the causes of Type 2 diabetes, its time-aspects and the consequences of complications However, in the I-group GPs counselling had a significant impact on the patients understanding of factors preventing complications and factors controlling the disease compared with the C-group This improved understanding or higher levels of awareness can also be interpreted as the patients acceptance of the disease and their interest in knowing which opportunities they had for preventing complications through lifestyle behavioural changes and adherence to medication Even though the differences obtained were small, the results do indicate that more patients in the I-group than in the C-group entered contemplation phase and thereby possibly increased their readiness to change behaviour With regard to the lack of change of alcohol intake behaviour, the results revealed that more than
98 of the patients in both groups were, in fact, within the treatment goals, which left only little room for demonstrating effect of Motivational interviewing The study showed a tendency that more GPs in I-group than C-group asked the patients about smoking status and behaviour Chapter 4, Table 3, page 44 However, no change was found in smoking behaviour, which may be caused by the GPs not using the opportunity to focus on smoking behaviour or the GPs not motivating for smoking behaviour change The patients statements indicated the latter, thus, that they were not motivated to change smoking behaviour Whether this was a result of GPs including many subjects eg smoking behaviour, lifestyle behaviour, Type 2 diabetes self-care etc in the same counselling encounter, or if it was their use of the Motivational interviewing, or the concept of Motivational interviewing itself, was difficult to determine for certain Implications for future research The study measured no effect on behavioural change, eg smoking status or alcohol intake, despite changes in patient beliefs, contemplation and readiness to change behaviour Thus, the measuring methods and the intervention of a study need to be
considered In this study, the method has shown overall effect on the contemplation of behavioural change It has previously been shown that a Motivational interviewing course seemed to influence GPs professional behaviour and GPs

reported that they used Motivational interviewing in their daily practice 103 This supports that Motivational interviewing does have effect, however long-term evaluation is needed in order to capture effect at both GP-level changing professional behaviour and patient level contemplation towards change and occurred change

Conclusion
This study reports a statistically significant effect of Motivational interviewing on patients beliefs regarding Type 2 diabetes and on their contemplation and readiness to change behaviour However, both groups obtained effects, and even though the effect of Motivational interviewing was statistically significant, it remained a small additional effect Thus, the importance of this finding in clinical setting is uncertain The study showed no significant change in actual change of smoking and alcohol intake behaviour Whether better results of Motivational interviewing can be obtained over a longer period of time has to be
investigated

Chapter 5
No effect of Motivational interview on risk profile in patients with Type 2 diabetes detected by screening A one year follow-up of a RCT ADDITION Denmark
Rubak S, Sandbaek A, Lauritzen T, Borch-Johnsen K, Christensen B

Abstract
Background: Motivational interviewing has been shown to be broadly applicable in the management of behavioural problems and diseases associated with unhealthy lifestyle Only few studies have evaluated the effect of Motivational interviewing on the treatment of Type 2 diabetes and none have explored the effect of Motivational interviewing on target-driven intensive treatment of this disease Aim: To investigate whether an improved risk profile can be achieved following implementation of Motivational interviewing in general practice Study design: Two groups of GPs were randomised to training in Motivational interviewing or not Both groups received training in target-driven intensive treatment of patients with Type 2 diabetes Methods: The intervention consisted of a 1-day residential course in Motivational interviewing with -day follow-ups twice during the first year Blood samples, case record forms, national registry files
and validated questionnaires from patients were obtained Results: The study showed statistically significant changes in terms of improved metabolic status and adherence during the intervention period within both randomisation groups However, there was no significant difference between the randomisation groups after one year Conclusion: Based on a one year follow-up, we found no effect of Motivational interview on the risk profile in patients with Type 2 diabetes detected by screening

Introduction
A large proportion of patients with Type 2 diabetes are treated in primary care Despite this, most previous studies on intensive multi-factorial treatment have been conducted in hospital setting 99;102 A major problem in these studies has been poor patient adherence to healthy life style and poor adherence to medication 99;102 New approaches to achieve behavioural changes are therefore required to be introduced Motivational interviewing is one of the rather well-documented, scientifically tested methods of client counselling developed by Miller and Rollnick and it is viewed as a useful intervention strategy for changing behaviour and improving disease management 2 Motivational
interviewing has been used in very few studies of Type 2 diabetes and the results have been varying 5;14;43;103 No investigations have evaluated its effect in relation to target-driven intensive treatment of patients with Type 2 diabetes detected by screening in primary care The aim of this study is to show whether a course in Motivational interviewing for general practitioners GPs improves patient adherence to intensive treatment based on an evaluation of the risk profile of patients with Type 2 diabetes detected by screening

Method
Study group This study is a sub-study of the ADDITION study 13, which is a multi-centre randomised controlled trial of a target-driven approach to intensive treatment of patients with Type 2 diabetes detected by screening All practices registered at the County Health Insurance Registry in Aarhus County were 1 January 2001 invited to meetings about participation in the ADDITION-study In Copenhagen County only practices located in the north and eastern part 7 municipalities were invited, because screening for diabetes had already taken place in the remaining municipalities in the county in connection with the Inter99 study In agreement with the County
Health Insurance only 60 GPs were to be included per county at study onset, and primarily practices with more than one GP were included No exclusion criteria for the GPs were applied and included GPs were randomised at practice level into a group giving standard care or an intervention group educated to intensive treatment including lifestyle intervention and poly-pharmacy aiming for rigorous values of blood glucose, blood pressure and lipids in addition to anticoagulation treatment This study included practices/GPs from the intervention group of the ADDITION study These practices/GPs were subrandomised into an intervention group I-group comprising GPs receiving a course with training in Motivational interviewing and a control group C-group comprising GPs receiving no formal training in Motivational interviewing Randomisation was stratified by county Copenhagen and Aarhus and size of practices GPs received training free of charge The inclusion of GPs and patients is shown in the flowchart, Figure 1 Patients were included in the study by the following inclusion-/exclusion criteria: All newly diagnosed Type 2 diabetes patients detected by screening aged 40-69 years were eligible
unless they were found to have contraindications or intolerance to study medication; a history of alcoholism, drug abuse, psychosis or other emotional problems that were likely to invalidate informed consent or adherence to treatment; malignant disease with a poor prognosis; or were pregnant or lactating Patients previously diagnosed with diabetes or treated with blood glucose lowering agents were excluded Diagnostic criteria for Type 2 diabetes is defined as fasting capillary whole blood glucose above 6,1 mM or oral glucose tolerance 2-hour test above 11,1 mM 13

Figure 1 Flowchart of included general practitioners GPs and screen-detected Type 2 diabetes patients T2D Eligible practices willing to participate N 48 including 65 GPs

Randomisation stratified by county and size of practice

Intervention group, trained in Motivational interviewing I-group, N 21 29 GPs

Control group, C-group N 27 36 GPs

GPs received residential course in intensive treatment of Type 2 diabetes GPs received residential course in Motivational interviewing

Follow protocol, guidelines, case record forms and patient material Inclusion of patients according to inclusion-/exclusion criteria GPs
meeting at follow up days, a day twice during the first year GPs included with one year follow-up Intervention group, I-group N 21 29 GPs Control group, C-group N 25 30 GPs

Patients included with one year follow-up N 137 T2D in I-group N 128 T2D in C-group

View Table 1 to see data rates on all data in I- and C-group 2 practices 6 GPs dropped out after randomisation 2 Type 2 diabetes patients dropped out after randomisation

Method of intervention The courses in Motivational interviewing for the GPs in the I-group were conducted by a single trained teacher, who had conducted several of these courses successfully The teacher is the first author of Motivational interviewing , a manual from the Danish Scientific Society of General Practitioners 2000 89 which together with Motivational interviewing, preparing people to change addictive behaviour 1991 2 constituted the theoretical part of the course curriculum Each course included 6-8 GP participants Each session started with a short introduction to the methods of Motivational Interviewing followed by group discussions and training the methods involving a high level of participation in workshops and role-plays The
principal rules of Motivational Interviewing in relation to the patient-doctor relationship 2 were trained as was the use of the specific skills eg empowerment 90, use of the ambivalence 2, the decisional balance schedule 2, visual analogue scale 2 and stage of change 91 and reflective listening 2 The courses for the GPs in the I-group consisted of a 1-day training sessions with a -day followup twice during the first year None of the GPs in I- and C-group had previously participated in a course in Motivational interviewing All GPs in the I- and the C-group had participated in the same training courses in intensive treatment of Type 2 diabetes patients This training course lasted half a day and follow up was performed as afternoon meetings twice every year During these diabetes training sessions, it was stressed that GPs should act as counsellors for the patients, allowing treatment decisions to be based on a mutual understanding between the patient and the GP In Denmark, GPs consultation encounters average 15 min and the County Health Insurance has agreed to one longer prophylactic encounter of 45 min per patient In this study the County Health Insurance agreed to allow the GPs in
the I- and C-group to undertake three consultations of 45 min per patient, in which the I-group could use Motivational interviewing Measurements The choice of effect parameters was based on the recommendations from evidence-based guidelines for treatment of Type 2 diabetes In these guidelines treatment goals are controlled by measuring HbA1c, lipid-profile, blood pressure and body mass index Furthermore the study aimed at reporting changes in adherence, which required other measures eg health care services, selfreported changes from GPs and patients The intervention phase began 1 May 2001 and included the 1-year follow-up data The study was based upon the following types of data obtained from all patients: Risk profile The use of blood sample data is addressed in Chapter 5 They include HbA1c, total serum cholesterol, serum LDL, serum HDL and serum triglycerides Baseline blood samples were analysed as follows: HbA1c was analysed using a Tosoh blood sample analyzer on venous whole blood drawn and stored in EDTA aliquots HbA1c reference interval is 4,1 to 6,1 Serum cholesterol, serum HDL-cholesterol and serum triglycerides were analysed using a Hitachi 917 System or an Abbott Aeroset
analyzer with an enzymatic colorimetric test as the test principle LDL-cholesterol was calculated using Fridewalds formula Reference interval for serum cholesterol is below 6,0mM, for serum HDL above 0,9mM, for serum triglycerides below 2,5mM and for serum LDL below 4,5mM All blood samples after baseline were analysed on several laboratories in the two counties, all subject to the Danish quality assurance for laboratories Body mass index BMI and systolic- and diastolic blood pressure measured sitting at rest at the GP were obtained from case record forms reported by the GPs

Health care services Prescribed medication was reported by the GPs on case record forms The number of prescriptions cashed in at the pharmacy by the patient was drawn from the National Health Service Registry The number of encounters and blood samples was obtained from register data files from the National Health Service Registry Self-reported data Data on smoking and exercise in leisure time and at work was obtained from patient questionnaires - The questions on physical activity had previously been validated in the International Physical Activity Questionnaire IPAQ 126 - The questions on smoking had
previously been validated in the Summary of Diabetes Self-Care Activities SDSCA questionnaire 95;112;116 Answering categories for the questions were dichotomised yes/no or presented on continuous scales On how many of the last 7 days did you ? The questionnaires were designed in and read by the computer program Teleform 118, which ensured reliable and valid data 119 Statistical method Data was blinded by the use of serial numbers in order to prevent observer bias Statistical analysis of data was conducted in SPSS version 110 Results are either given as median and quartiles, simple percentages or as mean and 95 confidence interval CI Paired T test was used to compare changes from 0 to 12 month A statistical significance level of 005 two tailed was used The clustering within GPs was adjusted for by using a mixed regression model assuming random normal variation between and within GPs

Results
A flowchart for participating practices GPs and patients can be seen in Figure 1 In all, 48 practices 65 GPs were included The 27 practices 36 GPs were randomised into the I-group and 21 practices 29 GPs into the C-group Two practices 6 GPs and 2 patients dropped out after randomisation All GPs
in the I-group participated in the educational and training courses, and less than 10 were absent from the -day follow-up meetings The study included 265 Type 2 diabetes patients with a 1-year follow-up; 128 in the C-group and 137 in the I-group The response rate to the patient questionnaire was 87 in the I-group and 90 in the C-group According to the case record forms, 74 patients in the I-group and 79 in the C-group had visited their GP one year after their inclusion in the study Table 1 The GPs had an average age of 53 years, were male in 2 out of 3, and had an average of 1500 patients in their practice with no significant differences between the study groups

Table 1 Data rate collected from patients after one year
I-group N137 data collected from patients T-Chol total serum-cholesterol mmol/l 70 HDL high density lipoproteins mmol/l 67 LDL low density lipoproteins mmol/l 61 Tgly triglycerid mmol/l 64 HbA1c GHb 91 Smoking status 88 Physical activity 86 Blood pressure 76 BMI Body Mass Index 79 ns non-statistical significant difference P 005 Group C-group N128 83 77 71 74 91 86 86 83 84 I-group vs C-group P-value P 005 P 005 P 005 P 005 ns Ns Ns Ns Ns

Among the 265
patients, 59 were males, average age of 62 years, 33 of patients with familiar history of diabetes, with no significant differences between the groups Measures for the risk profile at 0 and 12 months are presented in Table 2 A statistically significant improvement is seen in both groups from 0 to 12 month with no significance differences between the I- and the C-group Table 2 Risk profile measures at 0 and 12 month follow-up
Value Group Time Month Total values I-group C-group N 137 N 128 0 0-12 0 0-12 mean mean mean mean 1403 -64 1392 -73 838 -47 827 -44 59 -08 57 -06 13 01 13 01 36 -07 35 -07 24 -06 20 -03 73 -09 72 -09 303 -09 310 -08 661 66 712 78 33 09 35 05 06 38 07 P-value I- vs C-group N 137/128 Time 0-12 ns ns ns ns ns ns ns ns ns ns ns

Systolic BP Diastolic BP T-Chol total serum-cholesterol mmol/l HDL high density lipoproteins mmol/l LDL low density lipoproteins mmol/l Tgly triglycerid mmol/l HbA1c GHb BMI Body Mass Index Number of non-smokers F-H Number of days per week with hard physical activity example: aerobics F-M Number of days per week with 42 moderate physical activity example: bicycling in moderate tempo P 001, ns non-statistical significant
difference

The number of patients within the treatment targets and BMI 27 at study entry and after one year is seen in Table 3 Statistically significantly more patients in the C-group than in the I-group achieved the treatment goal for blood pressure

Table 3 Patients below treatment target and BMI 27 after one year
Time Group SBT DBT Cholesterol HbA1c BMI Achieved treatment goal at time 0 month I-group N137 C-group N128 of total N of total N 42 44 57 67 21 23 56 57 26 23 Achieved treatment goal at time 12 month P-value I- vs C-group Time 0 month ns ns ns ns ns I- vs C-group Time 12 month P005 P005 ns ns ns

SBT 45 57 DBT 60 74 Cholesterol 34 39 HbA1c 80 80 BMI 23 28 ns non-statistical significant difference P 005 Study treatment targets: SBT 135 systolic blood pressure mmHg, SBT 85 diastolic blood pressure mmHg T-chol 50 total serum-cholesterol mmol/l, HbA1c 64 GHb, BMI 27 Body mass index

There were no significant differences between the I-group and the C-group in the number of encounters or the use of blood tests used in general practice during the 1-year study period Table4 Table 4 Patients use of health care services in general practice after
one year
Group I-group N137 No Ordinary consultation 81 No Prophylactic consultation 12 No Blood samples 39 No Blood glucose 42 No Telephone consultation 59 ns non-statistical significant difference P 005 C-group N128 98 13 43 68 89 P-value Ns Ns Ns Ns Ns

The ratios between the proportion of patients reported by GPs to have had a prescription for blood glucose lowering drugs, BP or lipid lowering drugs and the proportion of patients registered to have cashed in a prescription for each of the three treatments at the pharmacy did not differ statistically significantly, either within or between the I- or the C-group Table 5 Table 5 Adherence to prescribed medication Prescriptions cashed in by patients at the pharmacy compared with prescriptions registered by the GPs after one year of patients
Medicin I-group N137 C-group N128 I vs C group of patients in group -ratio -ratio P-value Anti-hypertensiva 64/64 1 63/63 1 ns Lipid-lowering medication 42/42 1 47/47 1 ns Anti-trombotica 53/64 083 56/63 088 ns Oral antidiabetica 37/39 096 36/36 1 ns ns non-statistical significant difference P 005 X of patients cashed in a prescription of medication / Y of patients had registered a
prescription of medication from the GP

Discussion
Main findings Based on a 1-year follow-up, we found no effect of the motivational interview on the risk profile of patients with Type 2 diabetes detected by screening After one year, blood glucose, serum-lipid profile, blood pressure, physical activity, BMI, drug prescriptions reported by GPs, drug prescriptions cashed in at the pharmacy and the number of visits to the GP did not differ between patients being treated by GPs trained in Motivational interviewing and those who were treated by GPs who had received no such training The study showed significant changes in patient outcome with improved metabolic status and treatment adherence after one year within both groups Strength and limitations The validity of the study is strong by virtue of 1 the attendance of all GPs in courses intended for each group, 2 the absence of less than 10 GPs from the follow-up meetings, 3 a patient response rate to the questionnaire exceeding 87, 4 acquisition of 74 of the case record forms from GPs in the I-group and 79 from GPs in the C-group, and 5 acquisition of a 100 data rate from the National Health Service Registry Blood samples during the
1-year follow-up was obtained from 61-91 of the patients Table 1 This range may introduce a bias in the interpretation of data at the 61 end of this continuum Furthermore, data rates obtained on serum lipid profiles in the Igroup were statistically significantly lower compared to the C-group, which may introduce selection bias and tend to decrease the difference between the two groups The number of GPs and patients all in C-group dropped out of the study after randomisation is not expected to bias the results in consideration of the total number of GPs and patients included in this study The study did not include blinding, in which case behavioural changes may be influenced by the Hawthorne effect 124 However, in this PhD project both groups of patients were treated with intensive treatment, and only one group was further exposed to Motivational interviewing In this way attention to the treatment of Type 2 diabetes including lifestyle changes would increase in both groups and a potential Hawthorne effect would hence exist in both groups If the patients consciousness about changing lifestyle behaviour was raised because of the Hawthorne effect, this would tend to reduce the effect
of Motivational interviewing We cluster randomised at practice level in order to avoid contamination between intervention- and control group 120 The cluster design does affect the statistical analysis, because in this design the patients are not independent individuals statistically and the statistical analysis has to be performed using the number of cluster units, thus reducing the total number in the comparing groups 120-122 Cluster randomisation with a small number of units is not likely to show similar distributions of baseline characteristics among groups 123 However, we included 48 practices in 2 counties, which secured similar distributions in each treatment group Furthermore, we performed stratified randomisation of GPs on size of practice and on county We hence anticipate a high internal validity, a low degree of selection bias and a random allocation of unpredictable, immeasurable confounders This study may suffer from a limitation because training in Motivational interviewing was only performed by one person This makes outcome highly dependent on this persons teaching methods and capacity to train the GPs 103 This person was, however, highly experienced in the methods
of

Motivational interviewing and in teaching We evaluated the course and found GPs in the I-group adhered more to the methods of Motivational interviewing than GPs in the C-group 103 Detailed findings Adherence to prescribed medication was high compared with previous studies despite intensive poly-pharmacological treatment, however, there was no significant differences between the groups 127-129 This may be the result of the intensive training in treatment of Type 2 diabetes, where it was stressed that GPs should act as counsellors advising the patients how to reduce the risk of late diabetic complications and allowing treatment decisions to be based on mutual understanding between the patient and the GP This is indicated in a previously published paper in this study on how Motivational interviewing influences GPs professional behaviour 103 Thus, the effect of Motivational interviewing may have been reduced because of GPs in the C-group had a greater awareness into all aspects of Type 2 diabetes treatment, including motivating lifestyle changes The lacking effect of Motivational interviewing may also be ascribed to GPs failure to use all the potential three motivational
consultations made available by the study GPs in the I- and C-group on average used only one prophylactic consultation for each patient Thus, the possibility of an effect on the risk profile would have been higher if the GPs in I-group had used all three consultations deploying Motivational interviewing The results revealed that a large part of the patients in both groups had values eg HbA1c, lipidprofile, blood pressure or BMI that were, in fact, within the treatment goals from the beginning of the study This left only little room for demonstrating an effect of Motivational interviewing due to the narrowness of the intervention field However, significantly more patients in the C-group than in the I-group achieved the treatment goal of blood pressure reduction, but there was no significant difference in mean blood pressure between the groups The reason for this may be that the patients in C-group only had marginal increased blood pressure, and subsequently the patients achieved treatment goals with only a small decrease in blood pressure Thus, a difference between the study groups in patients achieving treatment goals of blood pressure was seen, however, with no significant
difference in mean blood pressure between the study groups Another reason for more patients in C-group than I-group achieving treatment goal for blood pressure may be that the GPs was too focused on the consultation process at the expense of disease management as reported earlier in a study with a similar design investigating patient-centred care targeting lifestyle changes 125 The issue of focusing on behaviour change eg diet counselling, thus leading to less focus on other medical treatment eg medication is addressed in a newly published paper in the Lancet 130 Implications for future research and practice The measuring methods used to observe patients behavioural changes included both self-reported measures, eg validated questionnaires and effect measures on patient outcome, eg HbA1c This ensured valid results regarding the effect of Motivational interviewing We have previously outlined that in order to obtain an effect of behavioural intervention, it is important to measure this effect at several levels, viz the level of 1 professional behavioural change, 2 patient behavioural change and/or attitudes to entering the contemplation phase of behavioural change, and 3 effect
measures, eg changes in risk profile 103 Previous studies using Motivational interviewing in general practice have proven an effect of this approach 21;24;36;38;43;60;64 However, only few studies have focused on how to implement Motivational interviewing in the daily clinical work in general practice in such a way that it is ascertained that the method is used after study closure 87;88 They concluded that it despite barriers

was possible to implement the use Motivational interviewing in general practice 87;88 This study showed that GPs found that implementation of Motivational interviewing was not timeconsuming and de facto used the same or fewer consultation encounters than GPs resorting to traditional advice giving 103 Thus, the results decrease the concerns over the time-consuming aspect of this technique and its concomitant expenses in primary health care services The study period lasted one year, a period during which the GPs received training and had to adapt to the methods of Motivational interviewing and to use the technique with a number of patients, make these patients change lifestyle to the effect that changes could be measured on their risk profile This PhD-study
has previously shown that 1 a Motivational interviewing course seemed to influence GPs professional behaviour, 2 GPs reported that they used Motivational interviewing in their daily practice, and 3 that patients changed contemplation of behaviour The findings of this study support the hypothesis that the non-significant effect of Motivational interviewing on risk profile may be a result of the studys attempt to accomplish too much over too short a period

Conclusion
Based on a 1-year follow-up, we found no effect of the motivational interview on the risk profile in patients with Type 2 diabetes detected by screening Two recent meta-analyses concluded that psychological therapies improve long-term glycaemic control, and Motivational interviewing, as one of these methods, had an effect on lifestyle factors like food intake, smoking, alcohol consumption and medication adherence 5;131 These meta-analyses side with the results of the present study on GPs professional behaviour and patient behaviour 103 in supporting the need for long-term evaluation of the effect of Motivational interviewing on the risk profile

Chapter 6
General discussion of methods

Introduction
This
section offers a comprehensive discussion of the methods used in this study, adding perspective to the research questions posed The issues raised are: 1 Setting of the study 2 Design cluster randomisation, bias, blinding, study evaluation 3 Intervention monitoring of intervention, adherence to the method of Motivational interviewing, changing and sustaining long-term change of professional behaviour 4 Measuring methods questionnaires to GPs, questionnaires to patients, case record forms, blood sample data, registry data 5 Statistical methods 6 Generalisation of outcome

Setting of the study
The clinical setting of this study was Danish general practice in the counties of Copenhagen and Aarhus The scientific setting of the study was conducted from the Department of General Practice, University of Aarhus and the Steno Diabetes Centre, Gentofte The ADDITION-study aimed at investigating the effect of early detection of Type 2 diabetes by screening and multi-factorial intensive treatment, including Motivational interviewing However, the ADDITION-study did not intend specifically to evaluate if and how the Motivational interviewing was used and implemented in patient-doctor relationship,
and if it yielded effect on treatment goals This PhD study focuses on the effect of Motivational interviewing on GPs professional behaviour, patients lifestyle behaviour and effect on patient risk profile The study was conducted in general practice, because treatment and follow-up of Type 2 diabetes is situated well in general practice Furthermore, general practice was preferred to hospital setting because of the GPs profound knowledge with each patient, and thereby the possibility of close follow-up by the GPs All practices registered at the County Health Insurance Registry in Aarhus County were 1 January 2001 invited to meetings about participation in the ADDITION-study In Copenhagen County only practices located in the north and eastern part 7 municipalities were invited, because screening for diabetes had already taken place in the remaining municipalities in the county in connection with the Inter99 study In agreement with the County Health Insurance only 60 GPs were to be included per county at study onset, and primarily practices with more than one GP were included No exclusion criteria for the GPs were applied and included GPs were cluster-randomised at practice level The
PhD study included furthermore a group of GPs who previously had participated in the course in Motivational interviewing EM-group This group was contacted externally to the ADDITION-study and was asked to answer the same questionnaire as GPs within the ADDITIONstudy, thus serving as a group of GPs with long-term knowledge of the use of Motivational interviewing The GPs in the EM-group did not participate in the ADDITION-study

Design
The research questions of this PhD thesis Chapter 1, Aim, page 4, were addressed at the level of the GP and the patient, using measuring methods on changing behaviour of GPs and patients and on specific effect, eg risk profile, in conformity with previous research advice 132 The study was conducted as a cluster-randomised controlled trial

Cluster randomised controlled trial The CONSORT principal rules of classic RCT presuppose the use of a homogeneous population, blinding and placebo treatment 123;133-135 However, the study design used here involved clusterrandomisation, ie it is a pragmatic RCT, which demands special statistical methods to be considered 122;135-137 Statistical analysis is, for example, affected by the reduced number of units for
randomisation 120;121;138-141, Statistical methods, Page 69 Cluster-randomisation with a small number of units is not likely to show similar distributions of baseline characteristics among groups 123 However, the study included 48 practices in 2 counties, which secured similar distributions in each randomisation group Furthermore, there was performed stratified randomisation of GPs on size of practice and on county Practices were chosen as randomisation units to prevent confounding between GPs Patients were randomised by their practice in order to avoid confounding between the I- and C- group Bias The study design, RCT, randomly allocates unpredictable, immeasurable confounders and diminishes selection bias Patients were included by known inclusion/exclusion criteria Figure 1, Appendix A and afterward randomised, thus diminishing the risk of selection bias However, the GP sample may have been biased because the GPs self-entered this study The GPs volunteering to courses and using a new intervention method may be a more motivated group of GPs and may thus be more interested in adopting and implementing new methods in general practice Furthermore the GPs attending the course in
Motivational interviewing may be more focused on including patients to the study in order to apply the methods of Motivational interviewing However, an equal number of Type 2 diabetes patients were included in the I- and C-group, which supports our assumption that selection bias was limited Patients baseline data age, gender, marital status, cohabit status, profession, educational background, family history of myocardial infarction and of diabetes, smoking status, alcohol intake status, ethnicity, weight, height, waist circumference did not differ between the randomisation groups Inclusion rates did not differ between the randomisations groups either Inclusion bias due to skewed inclusion numbers inclusion rate in intervention group exceeded inclusion rate in control group is therefore limited Two patients and six GPs all in control group dropped out of the study after randomisation In consideration of the total number of GPs and patients included in this study, attrition bias is viewed as insignificant 122 Data rates and response rates are listed in Table 1 Appendix A Blood samples during the 1-year follow-up was obtained from 61-91 of the patients Table 1 This range may introduce
a bias in the interpretation of data at the 61 end of this continuum Furthermore, data rates obtained on serum lipid profiles in the I-group were statistically significantly lower compared to the C-group, which may introduce selection bias and tend to decrease the difference between the two groups Blinding The use of an educational programme for intervention in practice prevents blinding It is, of course, not impossible to stage a placebo educational programme, but its effect would be doubtful as the GPs may easily learn from other GPs about their education, and thereby which education was intervention and which was placebo Without blinding, behavioural changes may be influenced by the Hawthorne effect 124 A Hawthorne effect is defined as when an intervention group have a tendency to change behaviour because they are targeted special attention in a study, regardless of the specific nature of intervention received 124 However, in this PhD project both groups of patients

were given intensive treatment and only one group was subsequently exposed to Motivational interviewing In this way attention to the treatment of Type 2 diabetes including lifestyle changes would increase in
both groups and a potential Hawthorne effect would hence exist in both groups If the patients consciousness about changing lifestyle behaviour was raised because of the Hawthorne effect, this would tend to reduce the effect of Motivational interviewing An increased consciousness on behaviour may be indicated by the high level of adherence in both groups compared with previous studies despite intensive poly-pharmacological treatment 127-129;142-144 Blinding of patients was intended Patients were obligated to give written informed consent to their participation in the study, however, they were not informed about whether their GP was allocated to the I-group or the C-group It was not checked whether some patients during the study learned about which treatment group their GP was assigned to It may have induced an increased motivation in the patient to know that your GP is in the I-group and vice versus Furthermore, the study was to be integrated into daily practice, therefore personal initiatives among both GPs and patients in terms of self-education was not opposed and have not been accounted for However, no GPs in this study had attended a course in Motivational interviewing prior to
the study Study evaluation Assessment of the implementation of an educational programme into routine care in general practice requires consideration of all the levels of implementation It is necessary to evaluate each level of the process relying on a combination of self-reported measures and effect measures of behaviour changes among both GPs and patients 145-147 In this study an effort has been made to use measuring methods evaluating all the levels The questionnaire data from the GPs focus on how implementation of a training programme changed the professional behaviour The questionnaire data from the patients make it possible to view changes in patient beliefs concerning Type 2 diabetes treatment and their contemplation and readiness to change behaviour Finally the specific effect measures make it possible to conclude whether Motivational interviewing had an effect on the patients risk profile In this field of intervention, RCTs do not practice follow-up periods exceeding one year 145, and this PhD study is also limited in the way that the evaluation rest on data obtained at the 1-year followup However, as a part of the ADDITION-study, the RCT has planned follow-up period of 5
years to evaluate the long-term effect

Intervention
The educational programme of Motivational interviewing is shown in Appendix B Intervention is described in detail in Chapter 3 to 5 Monitoring the intervention The effect of Motivational interviewing was measured at three levels, ie change at GP level, change at patient level and change in patient risk profile Assessing the effect at the GP level ie change of professional behaviour required evaluation of whether the course provided the GPs with skills that afforded them confidence in using Motivational interviewing for patient treatment, and monitoring of their actual use of the methods in their daily routines The study aggregated the effect of both processes, and therefore, it cannot be specified precisely how the different techniques were used by the GPs after the course It might have been possible to obtain information about actual use

and adherence to Motivational interviewing by viewing video recordings of counselling encounters This way of evaluation has been used previously in other studies of communication skills, and it seems to be a feasible method However, it requires detailed practical planning, training of the
GPs, considerable resources and acceptance from all participating doctors 148-155 This was not possible within the present study period and the resources were not available to use this approach in 48 practices and for 65 general practitioners in 2 counties In this study a questionnaire survey was conducted one year and three years after the course Besides this, the outcome of the training course was evaluated at the next two levels, ie changing patient behaviour and viewing actual change in patient risk profile as described in the section of Measuring methods below Adherence to Motivational interviewing It was expected that GPs in the group attending the course in Motivational interviewing would use the method in the patient treatment However, they were not forced to use the methods, and the extent to which they actually used the methods or adhered to the concept of Motivational interviewing was not monitored Another factor potentially influencing the use and adherence to Motivational interviewing is the GPs motivation to participate in the study In a RCT the GPs cannot decide themselves to which group and level of intervention and education they are allocated Therefore it is
possible that some GPs wanted to use Motivational interviewing, but were not randomised to this group, and vice versa In this way, GPs in the control group might have been motivated to do more than just traditional advice giving and GPs in intervention group might not have adhered to the method This would also tend to reduce the registered effect of Motivational interviewing Traditional advice giving is used as an expression for doctor-centred approach, ie the GP define the patients problem from a biomedical perspective and does not at all include the patient perspective on the matter, thus giving advice accordingly 12;83 Changing and sustaining long-term change of professional behaviour Changing counsellors professional behaviour in the doctor-patient relationship requires a tremendous effort 156 In this process, it is important to know how and where to influence the GPs 157 Multiple strategies based on different theories have been applied but very few studies have explored the long-term effect of training in interviewing skills and treatment 158-162 In order to obtain professional behaviour change, it is necessary to consider the teaching method carefully 163;164 GPs changing
professional behaviour will often have previous advanced experience, which requires that adult learning principles is applied in their education 165-170 If GPs are to be changed, new methods must be scientific based and relevant to general practice 161;162;171 In medical education passive learning by means of lectures has proven in-effective in terms of retained participants knowledge 172-174 Thus, the permanence and integration of professional behaviour change among GPs hinge crucially on practical training of the new method in a clinically relevant case settings, and on how easily the new method can be adopted and used the next day in practice Furthermore it must be clear for the counsellor, why the alternative professional behaviour is preferable 157 In the treatment of Type 2 diabetes patients in general practice, traditional treatment seems neither successful nor effective in terms of changing patient behaviour Hence, there seems to be a potential for stimulating change of lifestyle through improved professional conduct This improvement has to derive from a new strategy and this is an argument to retrieve and introduce new methods such as Motivational interviewing

Stott
et al performed a study on how GPs would react to adopting a new technology and new methods showing that GPs did, indeed, adopt, accept and use the new methods when they facilitated solutions to problems in the patient-doctor relationship 97 Only few studies have focused on how to implement and integrate Motivational interviewing in the daily clinical work in general practice in such a way that it is ascertained that the method is used after study closure 87;88 They concluded that it despite barriers was possible to implement the use Motivational interviewing in general practice 87;88

Measuring methods
The ADDITION-study is an on-going study based on primary and secondary endpoints evaluated after 5 years, including complete registry data on all included patients 13 The PhD thesis is based upon the following types of data obtained at the follow up after one year: - Questionnaires to GPs - Questionnaires to patients - Case record forms - Blood sample data - Register data files from the National Health Service Registry General practitioner questionnaire No validated questionnaire was available for evaluating the courses in Motivational interviewing and the GPs conception of the
methods, adherence to the technique and their actual use of Motivational interviewing A questionnaire was therefore designed drawing on 1 available theoretical knowledge about Motivational interviewing, 2 the leading authors knowledge from attending the course and 3 knowledge from the teacher and head of the course The questionnaire was designed in the computer programme Teleform 118 The questionnaire was self-administered and the processing of the questionnaire data was performed using Teleform The questionnaire was blinded by the use of serial numbers in order to prevent observer bias The Teleform method has been validated by a previous study comparing the use of Teleform and manual data entry, which found that the Teleform method was the more reliable and that it ensured valid data 119 Data were afterward automatically transformed into the Statistical Programme for Social Science SPSS version 110 for windows 175 and was once more checked for potential errors If an error was discovered, the original questionnaire was checked for correct answering and change was made in the database The questionnaire content, construction and pilot testing are addressed in Chapter 3 and the
questionnaire is shown in Appendix C The questionnaire was relevant and well-constructed, because it was understood by all the GPs and produced a 100 response rate The design of questionnaire and pilot testing ensured feasibility and high validity Patient questionnaire The patient questionnaire is addressed in the Chapters 4 to 5, and the questionnaire is shown in Appendix C The questionnaire used for assessment consisted of a collection of previously validated questionnaires used in primary care and for Type 2 diabetes patients These questionnaires were selected in order to measure the following aspects:

Counselling and patient-doctor relationship Health Care Climates Questionnaire HCCQ 104-108;176;177 was used to assess patients perceptions of the GPs counselling style This questionnaire has previously shown to be effective in disclosing the counselling style in many treatment areas 104-108;176;177 Contemplation of behaviour change Treatment Self-Regulation Questionnaire TSRQ 105;108-110;117;176-178 was used to assess the degree to which behaviour tends to be self-determined It involves three subscales to the main scale: the autonomous regulatory style; the controlled
regulatory style; and amotivation which refers to being unmotivated The autonomous style represents the most self-determined form of motivation and has consistently been associated with behaviour change and positive health care outcomes These subscales correspond to motivational concepts of selfdetermination theory proposed by William GC and Deci EL 104;106, which are partly based on concepts of Motivational interviewing, Miller and Rollnick 1 Understanding of Type 2 diabetes and its implications on life Diabetes Illness Representation Questionnaire DIRQ, which comprises 2 questionnai res: a Illness Perception Questionnaire IPQ 92;93;111;179-181 b Personal Models of Diabetes Interview Questionnaire PMDIQ 92;93;111;180;181 This questionnaire assesses whether Motivational interviewing acts to mediate the relationship between illness representations and emotional well-being in patients with Type 2 diabetes It assesses patients beliefs and understanding of Type 2 diabetes It involves 5 subscales to the main scale: Identity symptoms associated with the illness cause the cause of illness and beliefs about the factors responsible for the onset of the illness; timeline the patients
perception of duration of the illness ie acute, cyclical or chronic; consequences the patients expected outcome of the illness in terms of its likely physical, psychological, social and economic implications, which include impact on day-to-day life and in the long term; and control/treatment/effectiveness the patients beliefs about the extent to which the illness is amenable to cure or how good recommended treatments are at controlling the illness This study only used four of the subscales: cause, timeline, consequences and control/treatment/effectiveness Identity was excluded in order to limit the number of questions in the questionnaire and because all symptoms and objective findings were reported by the GPs on the case record forms Advice received on control and self care, and adherence to treatment and self care Summary of Diabetes Self-Care Activities SDSCA This questionnaire assesses to which extent Type 2 diabetes patients perceived advice on various self-care activities relevant to Type 2 diabetes It is a brief questionnaire previously validated in many studies and used to measure diabetes self-management 94;95;112-116;182-184 The questionnaire focuses on which advice from
the counsellor has been perceived by the patient in relation to: general diet and specific diet; exercise; testing and controlling by blood-glucose measurement and urine-glucose measurement; medication which type of medication has been prescribed by the doctor and to which extent has the patient adhered to the prescription; foot care self-rated self-care activity on patient foot care; and smoking status of smoking habits

The use of previously validated questionnaires combined with the pilot testing ensured feasibility and high validity The final questionnaire also enabled comparison with previous research

Case record forms The use of case record forms reported by GPs is addressed in Chapter 5, and the case record forms are shown in Appendix D Processing of the case record forms was performed by Teleform and analysis of case record form data by SPSS according to the description in GP questionnaire section above page 66 The case record forms at baseline and at 3, 6, 9, and 12 months were used in order to capture potential effects at different points in time However, no statistically significant differences were measured with 3 month intervals, and the results are
therefore presented as baseline, 6- and 12-month data The data response rate Table 1, Appendix A was found to be representative and valid Blood sample data The use of blood sample data is addressed in Chapter 5 They include HbA1c, total serum cholesterol, serum LDL, serum HDL and serum triglycerides Baseline blood samples were analysed as follows: HbA1c was analysed using a Tosoh blood sample analyser on venous whole blood drawn and stored in EDTA aliquots Serum cholesterol, serum HDL-cholesterol and serum triglycerides were analysed using a Hitachi 917 System or an Abbott Aeroset analyser with an enzymatic colorimetric test as the test principle LDL-cholesterol was calculated using Fridewalds formula All blood samples after baseline were analysed on several laboratories in the two counties, all subject to the Danish quality assurance for laboratories The blood sample data were fed into a database from case record forms reported by GPs and from data files obtained from the central laboratories These data were combined and displayed in one database by a data-manager to ensure accuracy and eliminate observer bias Data was blinded by the use of serial numbers in order to prevent
observer bias and to comply with the stipulations concerning regulation of databases, the Danish Data Protection Agency Data were afterwards automatically transformed into the Statistical Program for Social Science SPSS version 110 for Windows 175 Blood sample data were obtained at baseline and after 3, 6, 9 and 12 months in order to capture potential effects at different points in time However, no statistically significant differences were measured with the 3-month intervals, and the results are therefore presented as baseline, 6- and 12-month data Blood sample data was obtained in order to measure effect on the patients risk profile National Health Service Registry data The use of register data files obtained from the National Health Service Registry are addressed in Chapter 5 Data extraction was performed by a data-manager and retrieved into database for all included patients I used various types of data as measuring method which could have created problems during the data processing and analysis stages However, the support of a data-manager secured proper data-entry into the database and data could be analysed in SPSS

Statistical methods
The intervention, Motivational
interviewing, targeted the GPs and was supposed to be implemented into the daily clinical work in general practice Practices were randomisation units Thereby the included patients were cluster-randomised, meaning that they were allocated into clusters receiving different intervention depending on the grouping of their GP Statistically, the patients were therefore not independent individuals and the statistical analysis was performed at the level of the practice/GPs Variability between and within the clusters could arise if the sample included a small number of clusters, because of the individuality of GPs and/or their practices If variability between the clusters was present and ignored, the confidence intervals would become too narrow 120;122;137;139;185;186 However, when a study includes a large number of cluster units, variability is reduced to an insignificant level and balanced comparison is possible Random normal variation between and within the GPs was assumed on basis of the number of practices/GPs randomised in the study Statistical analysis was adjusted for the clustering within GPs by using a mixed regression model Before launch of the ADDITION-study and this PhD study,
power analysis was performed At that time the study assumed inclusion of approximately 650 patients in the intervention arm of the RCT in the ADDITION-study These 650 patients would be cluster-randomised to GPs trained in using Motivational interviewing or not At that time approximately 60 GPs within approximately 40 practices were expected to be cluster-randomised and that an average of 16 Type 2 diabetes patients would be included per practice In general practice, the intra-cluster correlation coefficient on outcome is approximately 003 to 005 121;187 However, Kerry et al investigated cholesterol in general practice and concluded that the intra-cluster correlation coefficient was 00036 138 In the power analysis, the intra-cluster correlation coefficient was conservatively estimated to be 005 on the remaining primary outcome measures When sample size in power analysis is to be corrected for cluster-sampling, the following equation was used: Nn/1m-1xICC NTotal number corrected of cluster-sampling nTotal number total number before cluster-sampling correction mAverage cluster size ICC Intra-cluster Correlation Coefficient This equation was used in order to reach the corrected number
N, which could be used in the power analysis for the outcome measures below: - HbA1c: N650/116-1×005 371 - Total cholesterol: N650/116-1×00036 617 - Adherence to prescribed medication: N650/116-1×005 371 - Smoking cessation: N430/116-1×005 245 It was assumed that approximately 2/3 of 650 patients within the intervention arm of the ADDITION-study were smokers, which makes N430

In the power analysis SPSS Sample Power Two Sample Proportion was used After correction of cluster-sampling it was concluded at that time, that the study would show effect 95CI of Motivational interviewing, if: - Min 19 patients reached normal HbA1c HbA1c below 6,4 - Min 15 patients achieved a 10 reduction of total cholesterol - Min 22 patients achieved smoking cessation - Min 19 patients adhered to prescribed medication adherence defined as 90 respecting the prescribed medication The study did achieve the inclusion of 65 GPs from the beginning of the study However, it did not reach the goals of including 650 patients within the intervention arm of the ADDITION-study At the data deadline of the PhD study, only 265 Type 2 diabetes patients with a 1-year follow-up had been included Thereby it was not
possible to fulfil the expectations of measured effect of the study This is supported by using post power analysis on the goals, as an example HbA1c: In power analysis 650 patients was used as N, which after correction for clustering allowed us by means of power analysis to conclude that Motivational interviewing would show effect if a min of 19 patients reached normal HbA1c HbA1c below 64 If the included number was used, N265, then the power analysis after correction for clustering concludes that Motivational interviewing would show effect if a min of 28 patients reached normal HbA1c HbA1c below 64 Finally, a large proportion 56 of the included patients had HbA1c within treatment goal from the onset of the study, which meant that these patients could not show any change due to Motivational interviewing If the number of included Type 2 diabetes patients who actually had an HbA1c level above the treatment target at baseline 44 of all included patients, N117 was used, Chapter 5, Table 3, page 56, then the number would decrease further and power analysis would, after correction for clustered sampling, conclude that Motivational interviewing would show effect if a min of 39 patients
reached normal HbA1c HbA1c below 64 Thus, a lower number of included Type 2 diabetes patients decreased the probability of achieving positive effect on patient risk profile Considering the form of intervention Motivational interviewing, the 1-year follow-up period, the patient population newly diagnosed Type 2 diabetes patients detected by screening, the actual number of included patients, and the large proportion of patients within treatment goal from onset of study, it is questionable whether the study goals could have been reached Retrospectively, the total number of expected patients should have been reduced in the power analysis in order to take into account that a proportion of the patients might have been within the treatment goal from the study onset However, the size of this proportion of patients was unexpected Furthermore, the study goals were deemed clinically relevant and realistic at the study onset which was important if the study should reach a conclusion recommending the implementation of Motivational interviewing in general practice in Denmark

Potential generalisation of outcome
This study had no exclusion criteria for the GPs, which secured external data
validity The study managed to diminish potential selection bias at GP level by including a large number of GPs from which only 6 GPs dropped out all in the control group after randomisation Figure 1, Appendix A Patient exclusion criteria were limited to patients previously diagnosed with diabetes, which should not influence the potential generalisation of outcome to the general population This study includes GPs randomised to a training programme in Motivational interviewing, which was flexible in relation to the GPs daily work and training in the practical use of specific methods was focused and targeted Type 2 diabetes patients Therefore it may be possible to generalise to GPs in Denmark as to how Motivational interviewing was implemented, how the method was used in the daily work in general practice, and which effect the methods had Furthermore, the use of Motivational interviewing is not limited to certain types of counsellors, ie GPs, psychologists etc, as shown in Chapter 2 Thereby, the effect of Motivational interviewing may be generalised to a hospital setting, however keeping in mind, that the method requires training and a continuum in the patient-doctor relationship
Thus, generalisation is probably limited to consultants because of their possibility of meeting the same patient in a treatment continuum Furthermore, motivating and changing behaviour in patients with Type 2 diabetes allows for generalisation to other disease areas

Chapter 7
General discussion of results

Introduction
Analysis of the data obtained in the PhD study has addressed the research questions put forward in the aim of the PhD study stated in the general introduction Chapter 1, page 2 The results and the analysis have been discussed in detail in the Chapters 3 to 5 This chapter will review the results and offer an overall discussion in relation to current literature

Discussion of results
Condition for obtaining an effect of the training course in Motivational interviewing The training in Motivational interviewing was to be learned through active participation in a residential course This course gave introductions to the different techniques of Motivational interviewing and it presupposed a high level of participation in subsequent groups, workshops and role-plays Thus, it may be a difficult process as a teacher to choose the way to present and train a concept
including a specific method and technique at the course 132;157;163;169;188 Thus, different demands have to be evaluated and accommodated to design the course in the best way possible In this process, subjects like teaching resources, incentives helping the GPs to set aside time for the courses and the contents of the course are crucial elements Residential courses in Motivational interviewing had previously been conducted several times by Professor Carl Erik Mabeck, and GPs had attended these courses Course evaluations had been positive but the courses had not been validated or been a part of a research study In this study it was chosen to train the GPs by using the same course, course curriculum and Professor Carl Erik Mabeck as teacher Chapter 3, page 26 2;89 The strategy of these courses, combining various multifaceted approaches cognitive, behavioural and affective components and training the methods of Motivational interviewing had been described in previous studies 189-191 Multiple theories and strategies have been proposed on how to achieve behaviour change and obtain adherence to methods 1;2;4;90;104;106;128;129;142;144;192-210 All these theories and strategies, including
the Motivational interviewing, have similarities, eg that behavioural change and adherence is achieved only by reaching a plan accepted by both the patient and the GP, allowing treatment decisions to be based on mutual understanding between the patient and the GP 98;189-191;211-218 It was deemed necessary for the intervention to obtain effect and have a sustained effect not only to conduct the course with a view to launching a process of professional behaviour change, but also to maintain the potential effect through follow-up meetings supervised by Professor Carl Erik Mabeck All GPs scheduled for the course during the study participated and with only few exceptions all GPs attended the follow-up days However, GPs were not supplied with further support in maintaining the use of Motivational interviewing or tools for self-evaluation in order to prevent lack of adherence to the method Besides this, the teaching style may also influence the implementation and use of the methods Thus, an ineffective teaching style in terms of teachers pedagogical abilities, contents and teaching method, size of teaching group may also decrease the use of Motivational interviewing and thereby influence
the effect on the patients risk profile However, the GPs found that the course had provided them with skills that afforded them great confidence in using Motivational interviewing for patient treatment It may, of course, be possible that availability of continuous supervision groups and self-evaluation methods would have increased the implementation and the use of Motivational interviewing even further

Effect of Motivational interviewing on general practitioners When focusing on the first level of change upon introducing Motivational interviewing, ie change of professional behaviour among the GPs, this study showed that a Motivational interviewing course influence GPs professional behaviour, thus providing the GPs with skills that afford them greater confidence in using Motivational interviewing for patient treatment In addition to this, GPs found that Motivational interviewing was more effective than traditional advice giving and that it improved the patient-doctor relationship Furthermore, the experienced GPs used the more complex parts of Motivational interviewing The GPs using Motivational interviewing found that the methods was not more time-consuming and that they de
facto used the same or fewer consultation encounters than GPs resorting to traditional advice giving 103 than traditional advice giving This has also been found in previous studies 88;98;219;220 However, the study provided no specific measuring of the actual use of Motivational interviewing or the extent to which the GPs adhered to the methods Therefore, it cannot be determined, on basis of the GPs self-rated use of Motivational interviewing, whether the poor effect on the patient risk profile was due to the concept of Motivational interviewing or to poor implementation of the method by the GPs In order to conclude on the specific use of Motivational interviewing and adherence to the methods, direct measuring method is required, eg video recordings of counselling encounters, as discussed in Chapter 6, Intervention, page 64 However, as described above, the study showed that GPs self-rated an effect of a course in Motivational interviewing on their professional behaviour and on their use of the method Thus, no effect on the patient risk profile may be caused by the limited observation period of change in patient behaviour as discussed below Besides this, the lacking effect on patient
risk profile may reflect our choice of GPs in the I- and Cgroup The study control group comprised GPs who were trained in intensive treatment of Type 2 diabetes, including giving advice on behaviour change Thus, GPs in C-group were not supposed to use Motivational interviewing, but they were urged to act as counsellors for the patients, giving them advice on how to reduce the risk of late diabetic complications and letting the treatment decisions to be based on mutual understanding between the patient and the GP Chapter 3, page 26 Thus, some of these GPs may have used elements from Motivational interviewing, which may have reduced the effect of Motivational interviewing The lacking effect of Motivational interviewing may also be ascribed to GPs failure to use all the potential three motivational consultations made available by the study GPs in the I- and C-group on average used only one prophylactic consultation for each patient This may be an indicator for poor implementation of Motivational interviewing and use of the method by the GPs Thus, the possibility of an effect on the risk profile would have been greater if the GPs in I-group had used all three consultations deploying
Motivational interviewing Effect of Motivational interviewing on patient behaviour change and patient risk profile The effect of Motivational interviewing at the second level, ie change at the level of patient behaviour eg lifestyle behaviour, adherence to prescribed medication, was monitored in terms of self-rated change eg smoking and alcohol status and effect measures external to the patient eg use of prescribed medication Chapters 4 and 5 This enabled us to evaluate the patients contemplation and readiness to change behaviour and the changes in behaviour that actual occurred The study showed significant an effect of Motivational interviewing on self-rated patient behaviour with patients becoming more motivated for change and for sustaining behavioural change The study obtained a statistically significant effect of Motivational Interviewing on patients beliefs regarding Type 2 diabetes and on patients contemplation and readiness to behaviour change However, even though the effect was statistically significant, it was small, and

the importance of this finding in the clinical setting remains uncertain The study showed no effect on actual changes in smoking and alcohol intake
behaviour In relation to change of alcohol intake behaviour, this may be caused by the fact that more than 98 of the patient population were within treatment goals from study onset which left only little room for demonstrating effect of Motivational interviewing The study showed a tendency that more GPs in I-group than C-group asked the patients about smoking status and behaviour Chapter 4, Table 3, page 44 However, no change was found in smoking behaviour, which may be caused by the GPs not using the opportunity to focus on smoking behaviour or the GPs not motivating for smoking behaviour change The patients statements indicated the latter, thus, that they were not motivated to change smoking behaviour Whether this was a result of GPs including many subjects eg smoking behaviour, lifestyle behaviour, Type 2 diabetes self-care etc in the same counselling encounter, or if it was their use of the Motivational interviewing, or the concept of Motivational interviewing itself, was difficult to determine for certain However, overall the patients found themselves to be more motivated for changing behaviour, thus it seems as Motivational interviewing has effect on the patients
contemplation of behaviour change Whether Motivational interviewing will induce measurable change in patient behaviour needs to be evaluated on a long-term follow-up period as planned in the ADDITION-study At the third level, changes were evaluated in terms of specific measures of the patient risk profile, in which no effect of Motivational interviewing were found It cannot be established for certain whether this is a result of lacking effect of Motivational interviewing, lacking use or adherence to Motivational interviewing from the GPs or if it is due to the limitations of the study design, eg the limited observation period of 1-year follow-up as previously discussed Design, Page 62 The review and the meta-analysis showed that a number of studies with a 1-year follow-up period had an effect on patient outcome measures Chapter 2 However, neither of these studies intervened on diabetes, but were related primarily to alcohol treatment performed by trained psychologists familiar with the methods of Motivational interviewing before study onset 15;16;23;31;33;4749;54;62;66;67;72;74 Only a few studies with a 1-year follow-up period and GPs as counsellor have been 21;45;46;51 These
studies showed effect, however, none of these focused on diabetes, but conducted on other different subjects 21;45;46;51 In all of these studies, the GPs were trained and familiar with the methods of Motivational interviewing before onset of the study, and they were thus focusing from study onset on patient behaviour change and patient outcome 21;45;46;51 It is possible that an effect on the patients risk profile might have been obtained within the 1-year study period if GPs had been trained and had been familiar with Motivational interviewing before the study was launched The lack of effect on outcome may also have been shaped by the the patient population newly diagnosed Type 2 diabetes patients detected by screening, the actual number of included patients, and the large proportion of patients within treatment goal from onset of study As discussed in the section Statistical methods page 69, this left little room for demonstrating an effect of Motivational interviewing The study showed effect of Motivational interviewing on the first level, the GPs professional behaviour and use of the method, and on the second level on the patients contemplation of behaviour change The
uncertainty on what caused no effect on patient risk profile may simply reflect how much effect the Motivational interviewing method accomplished in the process of change within the follow-up period the first year

Chapter 8 Conclusion

Conclusion
Chapters 6 and 7 have discussed the methods and results of the PhD thesis Chapter 8 presents the overall conclusion of the PhD thesis The review shows that Motivational interviewing has been used in treatment of various lifestyles and diseases, and 3 out of 4 studies obtained an effect no matter biological or psychological disease as shown in the meta-analysis Chapter 2, page 17 Motivational interviewing has an effect not only according to questionnaires, but also measured in terms of epidemiological and clinical measures and endpoints Motivational interviewing can be effective even in brief encounters of 15 min and the likelihood of an effect rises with the number of counselling encounters Motivational interviewing can be utilized with equal effect by physicians, GPs, psychiatrists and psychologists The PhD study shows that a Motivational interviewing course seems to influence GPs professional behaviour GPs found that the course
provided them with skills that afforded them greater confidence in using Motivational interviewing for patient treatment GPs also found that Motivational interviewing was more effective than traditional advice giving and that it improved the patient-doctor relationship Furthermore, the experienced GPs found that the method was not more time-consuming than traditional advice giving The study obtained a statistically significant effect of Motivational Interviewing on patients beliefs regarding Type 2 diabetes and on patients contemplation and readiness to behaviour change However, even though the effect was statistically significant, it was small, and the importance of this finding in the clinical setting remains uncertain The study did not show an effect of Motivational interviewing on actual lifestyle behaviour or on the risk profile in patients with Type 2 diabetes detected by screening The process of behaviour change in general practice is elicited and supported by different methods, eg Motivational interviewing 143;221-224 Motivational interviewing is a promising approach for changing and sustaining altered patient behaviour 88;220 A meta-analysis concludes that psychological
therapies like Motivational interviewing can improve long-term glycaemic control 131 Previous studies have also pointed to the need for more research on innovative approaches like Motivational interviewing to assist patient behaviour change and sustain adherence, and on methods for integration of such approaches into clinical settings, clinical guidelines and into the health care system 127;225-227 Thus, previous studies side with the results of the present study on GPs professional behaviour and patient behaviour Chapters 2 and 3 in supporting the need for long-term evaluation of the effect of Motivational interviewing on the risk profile

Chapter 9
Perspectives and implications for future research and practice

Perspectives
Implications for future research Previous research and use of Motivational interviewing has increasingly embraced aspects from other psychological models of behaviour change and different approaches for managing the patientdoctor relationship In order for future research to be able to recommend guidelines on how to use Motivational interviewing in practice, it is imperative that it makes an effort to describe exactly how the counsellor is educated and
trained, which methods are used and in what ways Motivational interviewing have been applied in the counselling This would improve the knowledge on what proved effective and it would allow us to recommend to future counsellors what to do in your present encounter with a patient in need for change In the process of analysing how and where Motivational interviewing will be effect, future research would benefit from a detailed discussion of models for implementation of the method in clinical setting, and the extent of generalisation from the project to other clinical settings Implications for practice Motivational interviewing is not limited to counselling of a small group of selected clients or use by certain types of counsellors Given the assumption that future research is able to provide more specific recommendations on how to use Motivational interviewing, it becomes important to clarify what is needed in order to initiate the process by changing professional behaviour This study showed that the use of a training programme requires an effort to sustain the spirit, enthusiasm and motivation of the professionals Immediately after the course, it is fun to adapt and apply new methods
However, as time passes, it becomes increasingly difficult to sustain a professional behaviour change, if the professional does not have visual sight of the advantages of using the method This may be assured by 1 listing progress in patient treatment, 2 using standardised methods of self-evaluation, eg video-recordings, 3 establishing supervision groups, and 4 by changing the organisational level in order to facilitate the process

Chapter 10
English summary

This PhD thesis is a part of the ADDITION-study, Anglo-Danish-Ducth study of intensive treatment in people with screen-detected diabetes in primary care, which was developed and implemented in cooperation between the Department of General Practice and the Steno Diabetes Centre This PhD thesis includes a 1-year follow-up of the effect of Motivational interviewing on newly diagnosed Type 2 diabetes patients detected by screening undergoing intensive polypharmacological treatment This thesis focuses on whether GPs using Motivational interviewing can increase adherence to and effect of intensive treatment of Type 2 diabetes patients risk profile, thus reaching treatment goals The PhD study was enrolled in 2001 and this
thesis was submitted in 2004 General introduction The PhD thesis consist of a general introduction, four articles, a discussion of methods and results and a conclusion with perspectives and presentation of future implications for research and practice Chapter 1 introduces the concept and methods of Motivational interviewing This PhD thesis is based on the definition of Motivational interviewing by Miller Rollnick, described in 1991 and elaborated in 2002 It has been used and evaluated internationally, especially during the last decade in relation to the following main areas 1 addiction alcohol abuse and addiction to drugs, 2 change in lifestyle smoking cessation, weight-loss, physical activity, asthma and diabetes treatment, and 3 adherence to treatment and to control, encounters of follow-up, counselling meetings Motivational interviewing has been deployed by various health care providers, including psychologist, doctors, nurses, dieticians and midwifes However, current studies have focused on the effect of Motivational interviewing in a hospital setting with no or little attention to how the methods could be implemented and applied afterward in daily clinical work This thesis
focuses on the effect of Motivational interviewing in general practice Motivational interviewing has only recently been introduced in Denmark, but its use has been rising over the past years and it has been deployed in different scientific and clinical settings Thus, in 2000 the Danish College of General Practitioners issued an introduction booklet on Motivational interviewing 11, which was mailed to all members of the Danish Medical Association Furthermore, a Danish book on the subject was issued in more than 10000 copies 12 and more than 30 residential courses in Motivational interviewing have been conducted by Professor Carl Erik Mabeck since These courses attracted mainly nurses, however, a number of GPs also attended the courses with a view to use the methods in general practice Thus, a significant effort has been made in order to enhance the use of Motivational interviewing in Denmark However, no research on the effect of this effort has so far been attempted Aim of PhD thesis The overall aim of this PhD thesis was to evaluate the effect of a course in Motivational interviewing on intensive treatment of Type 2 diabetes patients detected by screening in general practice
Furthermore, the PhD study aimed at evaluating: 1 The effectiveness of Motivational Interviewing as an intervention tool in previous randomised controlled clinical trials RCT and to identify factors shaping outcomes in the areas reviewed 2 In which way a 1-day course in Motivational interviewing and subsequent follow-up meetings influenced the GPs professional behaviour

3 If the GPs having participated in a course in Motivational interviewing found the method applicable and useful in general practice 4 If Motivational Interviewing in general practice can improve patients a contemplation and readiness to change behaviour, b their actual change in patient behaviour, and c their beliefs about Type 2 diabetes treatment 5 If a course in Motivational interviewing for GPs can improve the risk profile of Type 2 diabetes patients detected by screening Motivational interviewing, a systematic review and a meta-analysis Article 1 Chapter 2 describes the background of Motivational interviewing, reviews the literature and performs a meta-analysis on previous studies Its aim is to evaluate the effectiveness of Motivational interviewing in different disease areas and to identify factors
shaping outcomes The meta-analysis showed a significant effect of Motivational interviewing for combined effect estimates for BMI, total serum-cholesterol, systolic blood pressure, blood alcohol concentration, standard ethanol content, while combined effect estimates for cigarettes per day and for HbA1c were non-significant Motivational interviewing had a significant and clinically relevant effect in approximately 3 out of 4 studies with equal effect on biological 72 and psychological diseases 75 Psychologists and medical doctors obtained an effect in approximately 80 of the studies, while other health care providers obtained an effect in 46 of the studies How does an education and training course in Motivational interviewing influence general practitioners professional behaviour Article 2 Chapter 3 examines the first level in the process of measuring the effect of Motivational interviewing It presents the results of how a 1-day course in Motivational interviewing including follow-up meetings influenced GPs professional behaviour and GPs evaluation of the usefulness of the course in general practice The study showed that a Motivational interviewing course influenced GPs
professional behaviour GPs found that the course provided them with skills that afforded them greater confidence in using Motivational interviewing for patient treatment GPs found that Motivational interviewing was more effective than traditional advice giving and that it improved the patient-doctor relationship Furthermore, the experienced GPs used more complex parts of Motivational interviewing and found that the methods was not more timeconsuming than traditional advice giving Effect of motivational interviewing on beliefs and behaviour among people with Type 2 diabetes detected by screening Article 3 Chapter 4 analyses the second level in the process of measuring the effect of Motivational interviewing It brings the results of screen-detected Type 2 diabetes patients evaluation of the effect of Motivational interviewing in terms of the patients self-reported 1 contemplation and readiness to change behaviour, 2 their actual behaviour change, and 3 their beliefs regarding Type 2 diabetes The study showed a statistically significant effect of Motivational Interviewing on patients beliefs regarding Type 2 diabetes and on their contemplation and readiness to behaviour change
However, both groups obtained effects, and even though effect of Motivational Interviewing was statistically significant, it was a small additional effect Thus, the importance of this finding in the clinical setting is uncertain The study did not show any significant changes in lifestyle behaviour

No effect of the motivational interview on risk profile in people with Type 2 diabetes detected by screening A one year follow-up of a RCT Article 4 Chapter 5 presents the third level in the process of measuring the effect of Motivational interviewing It analyses whether a course in Motivational interviewing for GPs improved adherence to intensive treatment based on evaluation of risk profile in patients with Type 2 diabetes detected by screening The study showed no effect of the motivational interview on the risk profile of patients with Type 2 diabetes detected by screening at the 1-year follow-up Previous studies side with the results of the present study on GPs professional behaviour and patient behaviour in supporting the need for long-term evaluation of the effect of Motivational interviewing on the risk profile General discussion of methods Chapter 6 provides an overall
discussion of the methods of the study applied at the various levels of the process These methods are also discussed separately in the four articles Chapters 2 to 5 The discussion is divided into headings: Setting, Design, Intervention, Measuring methods, Statistical methods and Generalisation The difficulties of evaluating a training programme are discussed General discussion of results Chapter 7 comprises a discussion of all the results of the study obtained at the different levels of the study process: results which are presented separately in the four articles Chapter 2 to 5 The results are discussed in relation to current literature and accomplishments are detailed The discussion is structured into headings: 1 condition for obtaining an effect of the training course in Motivational interviewing, 2 effect of Motivational interviewing on general practitioners, and 3 effect of Motivational interviewing on patient behaviour change and patient risk profile Conclusion Chapter 8 presents the overall conclusions of this PhD study Motivational interviewing has been used in treatment of various lifestyles and diseases, and 3 out of 4 studies obtained an effect no matter biological or
psychological disease as shown in the meta-analysis The PhD study shows that a Motivational interviewing course seems to influence GPs professional behaviour Furthermore, the study obtained a statistically significant effect of Motivational Interviewing on patients beliefs regarding Type 2 diabetes and on patients contemplation and readiness to behaviour change However, the study did not show an effect of Motivational interviewing on the risk profile Perspectives and implications for future research and practice Chapter 9 draw the methods, results and conclusions of this PhD study into perspective and underscore the implications and recommendations for the future, divided into issues for research and practice

Chapter 11
Dansk resumé

PhD afhandlingen er en del af ADDITION-studiet og baseret på projektet Effekten af den motiverende samtale i intensive behandling af Type 2 diabetes Studiet blev afviklet i 2 amter, København og Aarhus, Danmark Studiet blev startet og styret i samarbejde mellem Institut og Forskningsenhed for Almen Medicin, Aarhus Universitet og Steno Diabetes Center, Gentofte PhD studiet inkluderer en 1-års opfølgning på effekten af den motiverende samtale på
screenede nydiagnosticerede Type 2 diabetes patienter intensivt behandlet PhD studiet fokuserer på effekten af den motiverende samtale på adherence og effekten af intensiv medicinsk behandling af Type 2 diabetes patienternes risiko profil PhD studiet blev indskrevet og optaget i 2001 og PhD afhandlingen blev indleveret i 2004 Introduktion PhD afhandlingen består af en generel introduktion, 4 artikler, en generel diskussion af metode og resultater med konklusion, samt perspektivering med anbefalinger i forhold til fremtidig forskning og fremtidig lægepraksis Kapitel 1 introducerer til de grundlæggende elementer af den motiverende samtale Denne PhD afhandling er baseret på Miller Rollnicks definition af den motiverende samtale, beskrevet i 1991 og uddybet i 2002 Den motiverende samtale har været brugt og blevet evalueret internationalt i den seneste årrække i relation til 1 misbrug alkohol misbrug og stof misbrug, 2 livsstilsadfærd rygning, overvægt, manglende fysisk aktivitet, astma og diabetes behandling, og 3 adherence til behandling og kontrolforløb Den motiverende samtale er blevet anvendt af mange forskellige behandlere, blandt andet psykologer, læger, sygeplejersker,
diætister og jordmødre Tidligere studier har udelukkende arbejdet med effekten af den motiverende samtale i hospitalssystemet uden at være opmærksom på hvordan denne metode kunne implementeres og anvendes i hverdagens kliniske arbejde efterfølgende I Danmark er anvendelsen af den motiverende samtale som metode relativt ny, dog er den over de seneste 5 år blevet mere udbredt I år 2000 udgav Dansk Selskab for Almen Medicin en klaringsrapport med vejledning i anvendelsen af den motiverende samtale, som blev udsendt til samtlige medlemmer af den Danske Lægeforening Desuden blev der udgivet en dansk bog på området, som blev solgt i mere end 10000 eksemplarer og endelig er der afholdt mere end 30 internats kurser i den motiverende samtale af Professor Carl Erik Mabeck Disse kurser har været målrettet til fag personer indenfor sundhedssektoren, men hoveddelen af deltagerne har været sygeplejersker Enkelte kurser er blevet afholdt primært målrettet mod praktiserende læger Der er således brugt store ressourcer på at indføre og forstærke brugen af den motiverende samtale i Danmark Indtil nu er der ikke udført forskning på effekten af den motiverende samtale i Danmark Formål med PhD
afhandlingen Det overordnede formål med PhD afhandlingen var at evaluere effekten af et kursus i den motiverende samtale på intensiv behandling af screenede nydiagnosticerede Type 2 diabetes patienter i almen praksis Derudover havde PhD studiet til formål at evaluere om: 1 Effekten af den motiverende samtale som intervention i tidligere randomiserede kontrollerede forsøg, samt hvilke faktorer som påvirker effekten af den motiverende samtale

2 Hvordan et 1-dags kursus i den motiverende samtale påvirker praktiserende lægers professionelle adfærd 3 De praktiserende læger efter et kursus i den motiverende samtale finder disse metoder anvendelige og mulige at integrere i deres kliniske arbejde i almen praksis 4 Den motiverende samtale i almen praksis forbedrer Type 2 diabetes patienters a parathed til at ændre livsstil, b deres aktuelle ændringer i livsstil og adfærd, samt c deres overbevisning og forståelse af Type 2 diabetes sygdommen 5 Et kursus i den motiverende samtale til praktiserende læger forbedrer Type 2 diabetes patienters risiko profil Den motiverende samtale, et systematisk review og en meta-analyse Artikel 1 Kapitel 2 beskriver baggrunden for den motiverende samtale
med en kritisk gennemgang af litteraturen, samt præsenterer en meta-analyse baseret på de tilgængelige data Målet var at evaluere effekten af den motiverende samtale set i forhold til forskellige sygdomsområder og desuden at identificere de mulige faktorer, som påvirker effekten Meta-analysen påviste signifikant effekt 95CI af den motiverende samtale for det kombinerede effekt estimat for body mass index BMI, blod total-cholesterol, systolisk blodtryk, blod alkohol koncentration, standard ethanol indhold, imens kombinerede effekt estimat for cigaretter pr dag og HbA1c var non-signifikant Den motiverende samtale vist signifikant og klinisk relevant effekt i omtrent 3 ud af 4 studier uafhængigt af om det drejede sig om biologiske/somatiske 72 eller psykologiske/ psykosomatiske 74 sygdomme Psykologer og læger opnåede ens effekt 80 i studierne, hvorimod andre sundheds faggrupper opnåede mindre effekt 46 i studierne Hvordan påvirker et kursus i den motiverende samtale praktiserende lægers professionelle adfærd Artikel 2 Kapitel 3 undersøger det første niveau i processen af at måle effekt af den motiverende samtale Her vises resultaterne af hvordan et 1-dags internats kursus i den
motiverende samtale påvirkede de praktiserende lægers professionelle adfærd, samt deres evaluering af metodernes anvendelighed et år efter kurset Studiet viste, at den motiverende samtale påvirker praktiserende lægers professionelle adfærd De praktiserende læger fandt, at kurset medførte kompetence til at anvende metoden i patientbehandlingen Desuden fandt de praktiserende læger at metoden den motiverende samtale var mere effektiv end deres vanlige rådgivning/samtaleteknik og at det forbedrede patientlæge forholdet Endelig angav de praktiserende læger, at anvendelse af den motiverende samtale ikke var mere tidskrævende end deres vanlige samtaler Effekten af den motiverende samtale på screenede Type 2 diabetes patienters overbevisning og adfærd Artikel 3 Kapitel 4 undersøger det andet niveau i processen af at måle effekt af den motiverende samtale Her bringes resultater af de screenede nydiagnosticerede Type 2 diabetes patienters evaluering af effekten af den motiverende samtale på patienternes 1 holdning og parathed til at ændre adfærd, 2 på deres aktuelle ændringer i livsstil, og 3 på deres overbevisning og forståelse for Type 2 diabetes sygdommen Studiet dokumenterede statistisk
signifikant effekt af den motiverende samtale på patienternes overbevisning og forståelse af sygdommen og dens konsekvenser, samt deres overvejelser og parathed til at ændre adfærd PhD studiet påviste dog effekt i begge grupper, og den signifikante effekt af den motiverende samtale var lille, hvilket medfører, at den kliniske betydning af dette fund er usikker Studiet påviste ingen ændringer i livsstilsadfærd i form af fx rygestop

Ingen effekt af den motiverende samtale på screenede Type 2 diabetes patienters risiko profil En 1-års opfølgning af et randomiseret kontrolleret forsøg Artikel 4 Kapitel 5 undersøger det tredje niveau i processen af at måle effekt af den motiverende samtale Her angives i hvilket omfang den motiverende samtale gennem ændring af faglig adfærd og herefter patient adfærd medførte effekt på patienternes risiko profil Studiet kunne ikke påvise ændring i risiko profil efter 1 år på screenede nydiagnosticerede Type 2 diabetes patienter Tidligere studier støtter sammen med resultaterne fra dette PhD studie, at det er nødvendigt at foretage lang tids evaluering af den motiverende samtales effekt på risiko profil Generel diskussion af metoderne Kapitel 6
diskuterer de metoder studiet har anvendt til at evaluere processen på de forskellige niveauer, hver især publiceret i de 4 artikler Kapitel 2 til 5 Afsnittet tillader en mere detaljeret diskussion, som indgående omhandler alle aspekter set i forhold til diskussionsafsnittet af hver enkelt artikel Diskussionen er inddelt i overskrifterne: setting, design, intervention, måle metoder, statistiske metoder og generalisering Problemstillinger i forbindelse med evaluering af et uddannelsesprogram diskuteres, samt hvordan studiet har forsøgt at løse disse problemer og på hvilken måde metoderne opfyldte kravene til evaluering af alle niveauer i denne proces Generel diskussion af resultater Kapitel 7 indeholder en diskussion af studiets resultater på de forskellige niveauer i processen, som alle er publiceret i de 4 artikler Kapitel 2 til 5 Resultaterne diskuteres i forhold til litteraturen på området Diskussionen er struktureret i overskrifterne: 1 forhold som påvirker muligheden for at opnå effekt af et kursus i den motiverende samtale, 2 effekten af den motiverende samtale på praktiserende læger, og 3 effekten af den motiverende samtale på patienternes ændring i adfærd, samt ændring i
deres risiko profil Konklusion Kapitel 8 præsenterer et resumé af konklusionerne fra diskussionen af metoder og resultater i PhD studiet, samt desuden en overordnet diskussion Den motiverende samtale har været anvendt i behandlingen af mange forskellige adfærdsområder og har vist signifikant og klinisk relevant effekt i omtrent 3 ud af 4 studier uafhængigt af om det drejede sig om biologiske/somatiske eller psykologiske/psykosomatiske sygdomme Derudover viste PhD studiet, at et kursus i den motiverende samtale påvirkede de praktiserende lægers professionelle adfærd til at anvende metoden Desuden dokumenterede studiet statistisk signifikant effekt af den motiverende samtale på patienternes overbevisning og forståelse af sygdommen og deres overvejelser og parathed til at ændre adfærd Endelig påviste studiet ikke en ændring i risiko profil efter 1 år på screenede nydiagnosticerede Type 2 diabetes patienter Perspektiver og studiets konsekvenser for fremtidig forskning og praksis Kapitel 9 sammenholder PhD studiets metoder, resultater og konklusioner i et fremtidig perspektiv og uddrager konsekvenser og anbefalinger for fremtidens forskning og klinisk
praksis

References

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102

Appendices

103

Appendix A

Figure 1 Flowchart of the ADDITION-study Eligible practices/General practitioners willing to participate in United Kingdom, The Netherlands and Denmark Randomisation stratified by county and size of practice

Intervention group Educated and trained in intensive multifactorial treatment of Type 2 diabetes including lifestyle advice, prescription of aspirin and ACE-inhibitors, in addition to protocol-driven tight control of blood glucose, blood pressure and cholesterol

Control group Following conventional treatment according to current national guidelines

In addition to intensive treatment, GPs are educated and trained in centre-specific interventions to motivate adherence to lifestyle changes and medication eg Motivational Interviewing

Intensive treatment with no further intervention

Inclusion of app 3000 patients with Type 2 diabetes following inclusion-/exclusion criteria: All newly diagnosed Type 2 diabetes patients detected by screening, aged 40-69 years, were eligible unless they were
found to have: contraindications or intolerance to study medication; a history of alcoholism, drug abuse, psychosis or other emotional problems that were likely to invalidate informed consent or adherence to treatment; malignant disease with a poor prognosis; or were pregnant or lactating Patients previously diagnosed with diabetes were excluded

Follow up is planned for 5 years Endpoints will include mortality, macro-vascular and micro-vascular complications, patient health status and satisfaction, process-of-care indicators and costs

Figure 2 Flowchart of included general practitioners GPs and Type 2 diabetes patients T2D Eligible practices willing to participate N 48 including 65 GPs Eligible practices/GPs, who two years previously attended a residential course in Motivational interviewing External Study group EM-group N 20 practices 20 GPs

Randomisation stratified by county Copenhagen and Aarhus and size of practice

Control group IC-group N 27 36 GPs

Intervention group trained in Motivational interviewing IM-group, N 21 29 GPs

GPs received residential course in intensive treatment of Type 2 diabetes GPs received residential course in Motivational interviewing Follow
protocol, guidelines, case record forms and patient material Inclusion of patients according to inclusion-/exclusion criteria GPs follow up days, day twice during the first year GPs included with one year follow-up Control group, IC-group N 25 30 GPs Intervention group, IM-group N 21 29 GPs GPs included with three years follow-up

External group, EM-group N 20 20 GPs

Patients included with one year follow-up N 128 T2D in IC-group N 137 T2D in IM-group

View Table 1 to see data rates on all data in IM- and IC-group 2 practices 6 GPs dropped out after randomisation 2 Type 2 diabetes patients dropped out after randomisation

Table 1 Data rate collected from patients after one year C-group: Control group of GPs N128 I-group: Intervention group of GPs trained inMotivational interviewing N137 Group data collected from patients T-Chol blood total cholesterol mmol/l HDL high density lipoproteins mmol/l LDL low
density lipoproteins mmol/l Tgly triglycerid mmol/l HbA1c GHb Smoking status Physical activity Blood pressure BMI Body Mass Index ns non-statistical significant difference P 0,05 I-group N137 70 67 61 64 91 88 86 76 79 C-group N128 83 77 71 74 91 86 86 83 84 I-group vs C-group P-value P 0,05 P 0,05 P 0,05 P 0,05 ns ns ns ns ns

Appendix B

Noter til

Den motiverende samtale
- et uundværligt redskab Carl Erik Mabeck Overordnet mål Øge deltagernes muligheder for at motivere patienter til adfærdsændringer, der er nødvendige for at realisere patientens ønsker om at opnå og bevare et godt helbred Specifikke mål Forstå det teoretiske grundlag for Den motiverende samtale Opnå kendskab til, hvordan den motiverende samtale gennemføres Lære at lytte aktivt reflective listening Lære at etablere et bæredygtigt forhold til patienten ved hjælp af PEARLS Lære at finde patienten, hvor han/hun er ved hjælp af VA-skaler og Forandringens hjul Lære at anvende Balanceskemaet Lære at rokke ved ambivalencen Lære at styrke patientens ressourcer empowering Lære at undgå fælderne
Undervisningsmetode: Voksenundervisning am Malcolm Knowles Adult learning is an internal process with the locus of
control of that process residing in the learner, but the process can be facilitated by outside helpers The learning is based on the assumption that you as a learner: 1 have the self-concept of being an adult and the desire and capability of taking responsibility for planning and managing your own learning with help from fellow students, the facilitator, and other helpers It is further assumed that what you learn through your own initiative you will learn more effectively than what you learn as a requirement by others 2 bring with you a rich background of experience that is a valuable resource both for your own learning and for the learning of fellow students It further assumes that your experience is different from the experience of other members of the course, and that your combined experiences represent a rich pool of resources for one anothers learning 3 are most prepared to learn those things you perceive will be most helpful in performing your lifes work and will allow you to achieve a higher level of performance It further assumes that the facilitator has the obligation to help you make the most use of the course, using your learning contract, in order to perform more
effectively 4 are unique, along with every other member of the course, because you have your own style and pace of learning, outside commitments and pressures, goals, and internal motivations For these reasons your learning plan and must be highly individualised

1 Hvad er problemet?
Spørgsmål Hvorfor gør patienterne ikke som vi siger? Svar: Fordi ingen voksne mennesker ændre adfærd, blot fordi vi siger det?

Vi har effektive behandlinger mod en lang række sygdomme Mindre end 50 af patienterne tage medicinen som foreskrevet Vores store folkesygdomme er livsstilsrelateret Mindre end 25 af patienterne følger vore velbegrundede opfordringer til adfærdsændringer Dårlig adherence compliance er ingen naturlov Behandleren har stor indflydelse på patientens adherence Dårlig udnyttelse af imponerende lægevidenskabelige fremskridt er den største udfordring for sundhedsvæsenet

3 Motivation er handlingsorienteret
Motivation er parathed til at handle Det kan være fortsættelse af en bestemt aktivitet fx motion, eller parathed til adfærdsændring fx rygestop Motivationen udtrykker sandsynligheden for, at personen gennemfører en bestemt handling

4 Den motiverende samtale er baseret på:

Vi behandler ikke patienter Når patienten er ude af døren, er det patienten, der afgør, hvad der bliver gjort Ingen handler imod deres overbevisning Ændre patienten overbevisning, ændre patienten adfærd Behandleren kan ikke ordinerer ændringer i patientens overbevisning Det er en almenmenneskelig reaktion, at forsøg på påvirkning vækker modstand Opleves påvirkningen som forsøg på indskrænkning af selvbestemmelsesretten, forstærkes modstanden Patientens ambivalens dvs diskrepansen mellem patienten ønsker om et godt helbred og opretholdelse af den aktuelle adfærd Patienten stimuleres til at reflektere over diskrepansen Løsningen skal findes i et samarbejde med den enkelte patient/klient og tage udgangspunkt i forståelse af: Hvem er patienten, hvad mener patienten og hvad er hendes situation, ønsker og muligheder? Vi kan styrke patientens muligheder til at finde sine stærke sider og sine ressourcer empowering

Hvad mener patienten?
Patientens overbevisning er afgørende for motivationen Nytter det? Kan jeg? Er det umagen værd?

Etik
Motivational interviewing is a directive client-centred counseling approach for initiating behaviour change by helping clients to resolve ambivalence
Miller og Rollnick Den motiverende samtale er både direktiv, non-direktiv og forhandlende Direktiv Patienten fastholdes i samtalen om ambivalensen Non-direktiv Patienten skal selv definere sine mål Forhandlende: Behandleren skal sammen med patienten finde en løsning Det er Behandlerens ansvar at informere og sikre, at patienten har forstået sin situation og sine muligheder Det er patientens ansvar at træffe en beslutning og gennemføre den

Nogle etiske grundbegreber
Teleologi regeletik Handlingens rigtighed er uafhængig af konsekvenserne Ex Vi skal respektere patientens ret til oplysning om diagnose og prognose uanset at det efter vor opfattelse skader patienten mere end det gavner patienten Deontologi konsekvensetik Handlingens rigtighed afhænger af konsekvenserne Ex Patienten skal kun oplyses om diagnose og prognose, hvis det gavner ham/hende mere end det skader Handlingen er rigtig, hvis den gavner mere end den skader Regelutilitarisme Reglen er rigtig, hvis den ud fra en generel og overordnet betragtning gavner mere end den skader, dvs uanset, at den kan medføre skade i enkelte tilfælde Ex Patienter skal altid have sandheden at vide om deres diagnose og prognose, fordi det
gavner skaber tryghed, tillid mm mere end det skader, uanset at nogle patienter bliver slået helt i stykker

5 Patient-centreret medicin Patient-centred medicine: To bridge the gab between a biomedical understanding of the
patients disease and understanding the patient as an individual in a unique situation

Den kliniske diagnose
Den medicinske diagnose Afvigelser fra en biologisk norm disease Naturvidenskab Fælles og upersonligt Objektive kriterier Undersøgelser Kvantitative data Personen og situationen Patientens oplevelser Illness Humanistiske videnskaber Individuelt Subjektive kriterier Kommunikation Kvalitative data

6 Hvordan kan vi hjælpe? Eksperten
Paternalistisk Behandleren definerer problemet og finder den rigtige løsning Informerer og ordinerer en behandling Behandleren tager ansvar for beslutninger Fokus på problemet

Rådgiveren
Behandleren respekterer patientens autonomi Patienten tager ansvar for beslutningerne Informerer og rådgiver Overtaler Ansvar til patienten Forkus på pts adfærd

Katalysatoren
Behandleren tror på patientens evner til selv at finde en løsning Stimulerer til refleksion Ansvar til patienten Fokus på pts
overbevisning

Sygdoms-centreret

Patient-centreret

Modstand
Det er en almenmenneskelig reaktion, at forsøg på påvirkning vækker modstand Opleves påvirkningen som forsøg på indskrænkning af selvbestemmelsesretten, forstærkes modstanden Modstand er en etikette, som behandleren sætter på klienter med visse typer af uønsket adfærd og ytringer Behandleren opfatter modstand som et karaktertræk hos patienten - ikke som en reaktion på behandlerens forsøg på påvirkning For patienten er modstand en naturlig, forståelig og fornuftig reaktion på behandlerens misforståelser og forsøg på overtalelse Det kan være nyttigt at se på modstand som et signal til behandleren om, at han går for hurtigt frem

8 Lytte aktivt
At lytte aktivt Reflective listening betyder: Du reflekterer non-verbalt kropssprog og lyde eller verbalt brug papegøje metoden, eller hellere omskrivninger Du reflekterer og resumerer, hvad du har opfattet som meningen med det, patienten siger, og de følelsesmæssige reaktioner, patienten viser Du stimulerer patienten verbalt og non-verbalt til at fortælle Du lytter hypotetisk og undersøger, om du har forstået korrekt Er det rigtigt forstået, at ? Du styrer samtalen ved at
reflektere på de informationer, du anser for vigtige

9 Hvad skal der til for at opnå patientens tillid?
The tree function model

Relationship building Develop, maintain, and conclude the therapeutic relationship Patient to feel cooperative, satisfied, and better Understanding the problem Determine and monitor the nature of the problem Data must be comprehensive, reliable, ands relevant Agreeing in management Tell a meaningful diagnosis Negotiate and implement a plan

10 Samtalens lag
Kliché laget Formål: Bryder isen og skabe tryghed Ex: Kunne du finde en parkeringsplads Sikken et vejr Facts referenceramme Meninger Formål: Forstå problemet inden for en sundhedsfaglig Ex Hvornår begyndte det? Har du haft det før? Forstå patientens handlinger Patientens tolkninger og opfattelse af nøglen til forståelse af hendes handlinger EX Hvis patienten tolker sin hovedpine som et muligt tegn på sygdom, går hun til læge Hvis hun tolker det som tegn på et dårligt indeklima, går hun til sin sikkerhedsrepræsentant Hvis hun tolker det som tegn på stres, går hun til sin arbejdsgiver Formål: Forstå, hvad det betyder for patienten Det er patientens følelsesmæssige reaktioner, der er nøglen til
forståelse af, hvad det betyder for hende Ex Angsten for, hvad det kan være eller udvikle sig til

Følelser

12 Tænk over noget, du gør eller ikke gør, der ikke er godt for dit helbred, men som egentlig synes, du burde gøre anderledes af hensyn til dit helbred
fx cykle til arbejde, dyrke mere motion, spise mindre fedt el lign Vigtigt: Det skal være noget, du ikke har noget imod at fortælle om i gruppen

Hvad?

13 Hvad skal der til for at opnå patientens tillid?
Det er spild af tid at begynde, før der er etableret et bæredygtigt forhold baseret på:

PEARLS:
Partnerskab Vi skal gøre noget sammen Empati Vise, at du forstår, hvordan det er at være i patientens sko Accept Møde patienten med en positiv og uforbeholden indstilling Respekt Viser, at du tro på, at patienten er i stand at tage ansvaret for sine beslutnigner Legitimering Patienten tænker logisk og hans/hendes følelser er ikke forkerte Support Jeg er her og vil gerne hjælpe dig - også fremover

14 Hvad er patientens motivation?
Hvor vigtigt er det for dig? Angiv på en skala fra 0 til 10 Hvordan vurderer du dine muligheder for at lave om på det? Skala 0-10

15 Hvor finder jeg patienten?
Det er afgørende at finde patienten
hvor han/hun er, og starte dér

Forandringens hjul Forandringens hjul efter Stage of Change Model, Prochaska
DiCelemente 1 Førovervejelsesstadiet
Patienten er ikke motiveret for at ændre adfærd og har derfor heller ikke tænkt på at gøre noget ved det Der er modstand mod forandring Hvorfor skal jeg altid høre om ? fornægtelse er karakteristisk Rygeren med bronkitis mener ikke, at rygningen er et problem Patientens indstilling kan også være en demonstration af, at patienten selv bestemmer Strategi: Vær ikke konfronterende eller argumenterende Spørg hellere: Har du nogensinde overvejet at holde op med at ryge? Hvad var grunden til, at du tænkte på at holde op?

2 Overvejelsesstadiet
Patienten anerkender, at der er et problem og begynder at tænke på forandring Patienten kan tale med Behandleren om det hensigtsmæssige i at ændre adfærd Men der er tale om løse og uforpligtende planer Rygeren kan i flere år tale om, at hun en dag vil holde op med at ryge Det er tale om en ambivalent indstilling Strategi: Forsøg at afdække ambivalensen sammen med patienten Få patienten til at reflektere over diskrepansen mellem ønsker og aktuelle adfærd Brug balanceskemaet Ingen forsøg på overtalelse

3
Forberedelsesstadiet
Patienten har besluttet sig til, at der skal gøres noget Fra på mandag vil jeg Men ambivalenseen er ikke afklaret Patienten har fortsat behov for at overbevise sig selv om, at det er nyttigt , muligt og umagen værd Strategi: Empowering Behandleren skal styrke patientens selvtillid og tro på, at det kan lade sig gøre Han skal også sørge for, at patienten har en realistisk vurdering af mulighederne for at løse opgaven Det er vigtigt, at det er patienten og ikke behandleren, der beslutter, at der skal ske noget

4 Handlingsstadiet
Patienten er i gang med forandringen Hun er holdt op med at ryge, spiser anderledes osv Hun er motiveret Strategi: Behandleren skal hjælpe patienten til at nå frem til den mest egnede løsning Behandleren skal finde den rette balance mellem at påvirke patienten og motivere patienten til selv at finde løsninger på sine problemer Hyppige kontakter kan være med til at understrege opfattelsen af, at det er vigtigt og at Behandleren går op i problemet Blodprøver eller et vægtskema kan fungere som redskaber i selvevalueringen og giver feed-back Lad patienten opbevare resultaterne

5 Vedligeholdelsesstadiet
Uden en stærk vilje og bevidsthed om,
at indgroede vaner ikke ændres i løbet af få måneder, men over år, er der stor risiko for tilbagefald Et vægttab fjerner ikke i sig selv årsagen til overvægt Det er jo ikke vægten, men patientens kostvaner, der er problemet Strategi: Behandleren skal hjælpe patienten med at identificere risici for tilbagefald og strategier for forebyggelse af tilbagefald Det er vigtigt, at patienten er instrueret i, hvad hun skal gøre hvis, eller helst før, der er tilbagefald

6 Tilbagefald
Succes er ikke en garanti mod tilbagefald Det er vigtigt at patienten kommer videre i hjulet og ikke låses fast i dette stadium Hvad var det, der skete? Hvad skal der til for at undgå tilbagefald? Hvad skal der til, for at komme i gang igen? Det er vigtigt, at behandleren hjælper patienten til at fatte mod og vende tilbage til det overvejende stadium Fokuser på patientens erfaringer Hvad var det, der gjorde det så svært?

12 Balanceskemaet
Skal jeg fortsætte? A Nævn mindst 3 gode grunde for dig til at fortsætte, f eks med at ryge Jeg kan lide det Jeg tror ikke, det er muligt osv B Nævn mindst 3 problemer for dig ved at fortsætte, f eks med at ryge Det er dyrt Det skader mit helbred osv Eller skal jeg ændre
adfærd? C Nævn mindst 3 fordele for dig ved at ændre adfærd, f eks holde op med at ryge Jeg får det bedre med min samvittighed Mine børn bliver glade osv D Nævn mindst 3 problemer for dig ved ændre adfærd, f eks at holde op med at ryge Jeg tager på i vægt Jeg bliver umulig at omgås osv

Pas på ikke at lægge hovedvægten på B og C Argumentation avler modargumentation Gevinster skal være konkrete, personlige og her og nu

13 Rokke ved ambivalensen
Working with ambivalence is working with the hart of the problem Miller Rollnick Ambivalens er en normal foreteelse
Målet er at få patienten til at overveje sin situation og få patienten til at ændre adfærd i retning af sine personlige mål hvis de er acceptable for Behandleren? Vi kan rokke ved ambivalensen i de situationer, hvor der er et misforhold mellem patientens adfærd og patientens ønsker om et godt helbred

Tro aldrig, at patienten opfatter cost-benefit på samme måde som du
Prøv ikke at overtale patienten Lad patienten selv komme med forslag og vær meget opmærksom på reservationer

Det er vigtigere at beskæftige sig med motiverne end med målene Behaviour is more likely to be altered if affective or value dimensions of desirability
are affected Miller Rollnick
Hvad vil patienten gerne opnå? Vægt, kolesterol, blodtryk osv er ikke et mål i sig selv

Patientens motiver kunne være: Jeg er utilfreds med mig selv Jeg er træt at være så tyk Jeg er bange for, at det skal gå mig lige som min mor osv Hvis patienten ændre overbevisning, ændre han/hun adfærd
Når patienten hører sig selv fortælle om mål og adfærd øges hans/hendes bevidsthed om diskrepansen Motivationen opstår, når patienten forstår diskrepansen og er overbevist om nødvendighed og muligheder for at ændre på forholdet

14 Empowering
Du skal finde patientens ressourcer i stedet for kun at fokusere på patientens svage sider Du skal hjælpe patienten til at tro på, at han/hun selv kan finde løsninger på sine problemer, og selv kan gennemføre en plan Dig for gold Not for shit Sam Putnam Problem Vores sygdomsmodel er fejlsøgende Vi er i langt højere grad uddannet til at finde patientens svagheder, end patientens stærke sider Empowering er udtryk for samarbejde og fordeling af ansvar og gensidig respekt Vær med til at skabe selvtillid hos patienten

Ros er det stærkeste medikament
Rollespil B Hvad gør du for at bevare dit helbred? Tænk på alt A Du skal: 1 Rose
Du skal vise din anerkendelser for patientens indsats Når patienten selv synes, at han/hun på trods af dårlige betingelser virkelig har gjort en indsats, skal du udtrykke din tilslutning 2 Kun stille åbne spørgsmål Du må gerne gå tilbage i tiden Du skal få B til at fortælle 3 Ikke komme med gode forslag, men demonstrere, at du tror på patientens gode vilje og sunde fornuft

15 Forhandle en plan
Ingen voksne mennesker ændre adfærd, blot fordi vi siger det?

I skal sammen finde en løsning, men det er patienten, der skal gennemføre den Give råd Hvordan kan det gøres? Ikke: Hvorfor det skal gøres
Patienten afgør om dine velmente råd kan bruges Vær ikke for ivrig Hellere være lidt kostbar med gode råd Er du sikker på, at jeg er bedre til at finde på løsninger, end du selv? Tror du, du kan bruge mine forslag? Forslag kan gives i en uforpligtende og upersonlig stil: Det er en mulighed Du kan måske bruge det

Fjerne barrierer Hjælpe med at identificere og overvinde forhindringer
Vigtigt at patienten føler, at han/hun har valgmuligheder Reagér på modstand med eftergivenhed Prøv at forstå og lad patienten forklare Pas på ikke at være for ivrig og negligere modstand Hvis
sukkersygepatienten har en dårlig adherence, kan du ikke løse problemet, men hjælpe patienten til at finde en løsning Patienten er nøglen til forståelse af, hvorfor det ikke fungerer Er patienten ikke overbevist? Er der praktiske forhindringer Er patienten bange for bivirkninger? Minder medicinen hende for meget om sygdommen? Osv Du skal undgå lukkede spørgsmål

Undgå argumentation
Du burde gøre noget ved det fører til: Ja, men - og Behandleren tror, at patienten er uinteresseret The confrontation-denial trap Argumentation avler mod-argumentation Patienten skal ikke overtales, men presses til at indse konsekvenserne og overveje situationen i lyset af dine oplysninger Det er patienten, der skal præsentere argumenterne for adfærdsændringer

Give feedback Feedback skal være konkret og konstruktiv Sig hvad du synes patienten gør godt
Vær rosende og konkret Lad være med at kritisere Kritik skaber afstand Kom hellere med konstruktive forslag om, hvad man også kan gøre Styrke patientens selvtillid

Resumere Periodiske resumeringer sikre: - at I er enige og har forstået, hvad er der er aftalt - Reinforcerer aftaler og motivationen Rollespil Hvad vil og kan patienten? Oplæg Brug f eks
balanceskemaet Hvor er du nu med din sukkersyge? Rok ved ambivalensen og brug empowering Tag udgangspunkt i figuren Vigtigheden-Kan jeg? punkt 6
Hvad er du god til? Hvad vil du gerne opnå? Hvad skal der til for at nå målet? Hvad kan du selv gøre? Hvad vil jeg gerne have, at andre hjælper dig med? Hvad er det første, der skal ske? Hvem vil du fortælle om din beslutning?

16 Pas på fælderne
11

Ekspertrollen Jeg er eksperten på det medicinske område Patienten er eksperten i sit liv Informationer modificeres Alle informationer tilpasses patientens begrebsverden For mange informationer For mange informationer slår hinanden ihjel som her? Mod-argumentation Argumentation avler mod-argumentation Skræmmebilleder Får nogle patienter til at lukke øjnene Spørgsmål-svar fælden Pas på den interessere og videbegærlige patient Utålmodighed Pas på, du ikke taber patienten undervejs Prøv ikke at løse for mange problemer på én gang Det bedste er det godes fjende At overhøre modstand Viser patienten modstand, skal du starte med den Patientens afvisning Prøv ikke at presse dig igennem Det øger patientens modstand Den nemme og flinke patient Overlader ansvaret til dig - og gør ikke noget selv
Urørlighedszonen Overtræd ikke patientens grænser Blaming the victim Det er ikke et spørgsmål om placering af skyld, men af ansvar

17 Vi er selv en del af processen
12

Min private huskeseddel
1 Patienten handler i overensstemmelse med sin egen overbevisning
Patienten handler ikke på grundlag af informationer og min overbevisning Patienten foretager en selvstændig tolkning af de givne informationer Mine vurderinger og forslag tolkes sammen med mange andre informationer og påvirkninger Resultatet af denne tolkning er afgørende for, hvordan hun handler Hvis patienten ændrer opfattelse, ændrer han/hun adfærd i overensstemmelse hermed Det nytter intet, at jeg er overbevist om at mine løsninger og forslag er geniale Ingen handler imod deres egen overbevisning, heller ikke patienten

2 Gengælder jeg patientens tillid?
Med sin henvendelse viser patienten mig sin tillid Gengælder jeg denne tillid? Opfatter jeg og behandler jeg patienten som et selvstændigt og ansvarligt menneske, der er i stand til på fornuftig vis at tage vare på egne forhold? Viser jeg, at jeg tror på hende? Hvis jeg ikke tror på, at patienten er den bedste til at løse sine problemer, hvad er det så, jeg tror på?

3 Jeg
kan ikke lave om på patienten Det kan kun patienten selv
Motivation til forandring skal komme fra patienten og ikke påduttes af mig Det er ikke mig, der skal vurdere fordele og ulemper ved adfærdsændringer? Men jeg skal gøre mit bedste for at patienten forstår sin situation og sine muligheder Ambivalente følelser opstår, når der er uoverensstemmelse mellem mål og adfærd Balanceskema Det er patientens opgave at formulere og finde en løsning på sine ambivalente indstilling Jeg forsøger at rokke ved ambivalensen med det formål at tippe balancen til fordel for en sundhedsfremmende adfærd

4 Patienten kender sin situation og sine muligheder bedre end jeg
Jeg er eksperten på det medicinske område Men patientens situation er unik, og hun er eksperten, når det gælder kendskab til hendes baggrund, viden, overbevisninger, værdinormer, situation, mål og ønsker Er det mig, der har fundet en løsning på patientens problemer med udgangspunkt i mine personlige forestillinger om patientens liv? Har jeg interesseret mig for patientens problemer eller for patientens ressourcer?

5 Hvis jeg ikke finder patienten der, hvor han/hun er og starter der, opnår jeg ingenting
Kirkegaard: At man, når det i
Sandhed skal lykkes En at føre et Menneske hen til et bestemt Sted, først og fremmest maa passe paa at finde ham der, hvor han er, og begynde der Motivationens stadier Forandringens hjul

6 Dårlig compliance afhænger af mig
90 af alle patienter følger ikke vores gode råd om adfærdsændringer Det kan blive bedre Jeg må tro på, at jeg kan gøre noget Parathed til forandring afhænger af mig Forsøg på overtalelse er ikke en effektiv metode til ændring af patientens adfærd Jeg skal undgå en egentlig diskussion med patienten Modstand mod forandring er ikke et karaktertræk hos patienten, men en reaktion på min indsats

7 Aldrig sige bare

Bare røber, at jeg ikke forstår, hvorfor det er så svært for patienten Hvis det bare var så let, søgte patienten ikke din hjælp Min rolle er at være lyttende, spørgende og tilbageholdende Med interesse og spørgsmål stimulerer jeg patienten til selv at reflekterer over sin situation og sine muligheder

8 Gentagelse hjælper ikke prøv noget nyt
Hvis patienten ikke har handlet i overensstemmelse med mine gode råd og forslag, er der måske noget galt med dem Ved jeg, hvorfor patienten ikke kan bruge dem? Det nytter intet med gentagelser Prøv at finde på
noget nyt

9 Det er lettere at narre mig selv end patienten
Jeg vil så gerne hjælpe og vise, at jeg kan udrette noget Det gør mig blind og ukritisk Al erfaring viser, at jeg uhyre let kan bilde mig ind, at patienten såmænd nok ændre mening og handler i overensstemmelse med mine gode og velmente råd, når hun får tænkt sig godt om Der er intet erfaringsmæssigt belæg for denne opfattelse Derimod mange, der viser, at det er forkert Tør jeg bede patienten om at resumere, hvad vi har talt om og er nået frem til?

10 Pas på fælderne

Appendix C

Spørgeskema tid 0

Side 1

Løbenummer

0 Hvad er dit personnummer?

Følgende 6 spørgsmål handler om dig og dit helbred generelt Besvar spørgsmålene med det udsagn, der bedst beskriver din helbredstilstand i dag Markér kun et svar ved de følgende spørgsmål 1 Bevægelighed
Jeg har ingen problemer med at gå omkring Jeg har nogle problemer med at gå omkring Jeg er bundet til sengen

2 Personlig pleje Jeg har ingen problemer med min personlige pleje Jeg har nogle problemer med at vaske mig eller klæde mig på Jeg kan ikke vaske mig eller klæde mig på 3 Sædvanlige aktiviteter feks arbejde, studie, husarbejde, familie- eller fritidsaktiviteter
Jeg
har ingen problemer med at udføre mine sædvanlige aktiviteter Jeg har nogle problemer med at udføre mine sædvanlige aktiviteter Jeg kan ikke udføre mine sædvanlige aktiviteter

4 Smerter/ubehag
Jeg har ingen smerter eller ubehag Jeg har moderate smerter eller ubehag Jeg har ekstreme smerter eller ubehag

5 Angst/depression
Jeg er ikke ængstelig eller deprimeret Jeg er moderat ængstelig eller deprimeret Jeg er ekstremt ængstelig eller deprimeret

6 Sammenlignet med min helbredstilstand gennem de seneste 12 måneder, er min helbredstilstand i dag
Bedre Stort set den samme Værre
3091

Spørgeskema tid 0

Løbenummer

Side 2

7 For at hjælpe dig med at sige, hvor god eller dårlig din helbredstilstand er, har vi tegnet en skala næsten ligesom et termometer, hvor den bedste helbredstilstand du kan forestille dig, er markeret med 100 og den værste helbredstilstand du kan forestille dig, er markeret med 0

Bedst tænkelige helbredstilstand 100

Vi beder dig angive på denne skala, hvor godt eller dårligt du mener dit eget helbred er i dag Angiv dette ved at tegne en streg fra kassen nedenfor til et hvil- ket som helst punkt på skalaen se eksempel, der viser, hvor god eller dårlig din
helbredstilstand er i dag

Eksempel:

1
Skal ikke udfyldes Forbeholdt kodning

0 Værst Bedst tænkelige tænkelige helbredstilstand regulering
3091

Spørgeskema tid 0

Løbenummer

Side 3

Herunder finder du en række udsagn, som forskellige personer har brugt til at beskrive sig selv Læs hvert udsagn og sæt en markering i den cirkel, der bedst udtrykker, hvordan du har det lige nu, i dette øjeblik Der er ingen rigtige eller forkerte svar Brug ikke for meget tid på et enkelt udsagn, men angiv det svar, som bedst beskriver dine nuværende følelser

Slet ikke 8 9 10 11 12 13

I nogen grad

I rimelig grad

Meget

Jeg føler mig rolig Jeg er anspændt Jeg føler mig oprevet Jeg er afslappet Jeg føler mig tilfreds Jeg er bekymret

Følgende spørgsmål handler om forskellige sider af livet Hvert spørgsmål har 7 svarmuligheder Du bedes besvare hvert spørgsmål ved at sætte en cirkel om det tal på hver af skalaerne, du synes passer bedst med din mening
14

Oplever du at du er ligeglad med det, der sker omkring dig?
Ofte

Meget sjældent/aldrig

Er det sket for dig, at du er blevet overrasket over opførslen hos personer, du
kendte godt?
Det er sket mange gange

Det er aldrig sket

Er det sket, at folk, som du stolede på, har skuffet dig?
Det er sket mange gange

Det er aldrig sket

Indtil nu har dit liv
Helt savnet mål

Haft både mål og mening
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18 Føler du dig uretfærdigt behandlet? Meget ofte

Side 4

Løbenummer

Meget sjældent/aldrig

19 Oplever du, at du i en uvant situation ikke ved, hvad du skal gøre? Meget ofte 20 Er din dagligdag kilde til Glæde og dyb tilfredsstillelse

Meget sjældent/aldrig

Smerte og kedsomhed

21 Har du modstridige tanker og følelser? Meget ofte

Meget sjældent/aldrig

22 Sker det, at du har følelser i dig, som du helst ikke vil føle? Meget ofte

Meget sjældent/aldrig

23 Selv mennesker med stærk personlighed kan ind imellem føle sig som en taber Hvor ofte

har du følt dig sådan?
Aldrig

Meget ofte

24 Hvor tit oplever du, at du over- eller undervurderer betydningen af noget, der sker? Meget ofte Aldrig

25 Hvor ofte føler du, at de
ting, du foretager dig i din hverdag, er uden mening? Meget ofte

Meget sjældent/aldrig

26 Hvor ofte har du følelser, som du ikke er sikker på, at du kan kontrollere? Meget ofte

Meget sjældent/aldrig

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Side 5

Løbenummer

De følgende 6 spørgsmål handler om Deres motionsvaner

Angående besvarelse af følgende spørgsmål Hård fysisk aktivitet er en aktivitet, der kræver en stor fysisk anstrengelse og gør din vejrtrækning meget hurtigere end normalt Moderat fysisk aktivitet er en aktivitet, der kræver en moderat fysisk anstrengelse og gør din vejrtrækning noget hurtigere end normalt

27 Hvor mange dage i løbet af de sidste 7 dage har du været i hård fysisk aktivitet, som fx tunge løft, gravearbejde, konditræning eller cyklet hurtigt? Tænk kun på de aktiviteter, du udførte mindst 10
minutter ad gangen

Dage

Ingen gå til spørgsmål 28

a Hvor megen tid brugte du sædvanligvis på hård fysisk aktivitet en af disse dage? Timer Minutter

28 Igen skal du kun tænke på den fysiske aktivitet, du udførte mindst 10 minutter ad gangen Hvor mange dage i løbet af de sidste 7 dage har du været i moderat fysisk aktivitet, som fx at løfte
lettere ting, cykle i jævnt tempo eller spille en double i tennis? Gåture skal ikke medregnes Dage Ingen gå til spørgsmål 29

a Hvor megen tid brugte du sædvanligvis på moderat fysisk aktivitet en af disse dage? Timer Minutter

29 Hvor mange dage i løbet af de sidste 7 dage har du gået i mindst 10 minutter ad gangen? Medregn, hvor meget du går på arbejdet og derhjemme, gåture for at komme fra et sted til et andet og alle andre gåture, som du foretog i forbindelse med fornøjelse, sport, motion eller fritid Dage Ingen gå til spørgsmål 30

a Hvor megen tid brugte du sædvanligvis på at gå en af disse dage? Timer Minutter
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Side 6

Løbenummer

30 Det sidste spørgsmål handler om, hvor lang tid du sidder ned på hverdage, både når du er på arbejde, hjemme, på kursus og i fritiden Medregn den tid du sidder ved et skrivebord, besøger venner, læser, kører i bus eller sidder eller ligger, mens du ser fjernsyn I løbet af de sidste 7 dage, hvor lang tid har du i gennemsnit siddet ned i løbet af en almindelig hverdag? Timer Minutter

31 Har du et arbejde ude eller hjemme?
Sæt kun én markering

Nej gå til spørgsmål 32

Hvis Ja, hvilken af følgende grupper mener du selv,
at du tilhører på din arbejdsplads?

Du sidder for det meste ned og går ikke ret meget omkring på arbejdspladsen
fx skrivebordsarbejde, samle smådele og lignende

Du går en del omkring på arbejdspladsen uden at skulle slæbe på tunge ting
fx lettere industriarbejde, ikke stillesiddende kokntorarbejde, husligt arbejde, undervisning og lignende

Du går for det meste og må ofte gå op ad trapper og løfte forskellige ting
fx postombæring, byggearbejde, flytte tunge møbler og lignenede

Du har legemligt arbejde, løfter tunge ting og anstrenger dig fysisk
fx gravearbejde, skovarbejde, jord- og betonarbejde og lignende

32 Hvilken af følgende grupper mener du selv, at din fritidsbeskæftigelse omfatter?
Sæt kun én markering

Du sidder som regel og læser, ser fjernsyn, går i biografen og tilbringer fritiden med stillesiddende sysler Du går tur, kører lidt på cykel eller er i legemlig aktivitet mindst 4 timer om ugen
lettere fritidsbyggeri, bordtennis, bowling og lignende

Du er aktiv idrætsudøver mindst 3 gange ugentlig Hvis du ikke dyrker sport, men ofte udfører tungt havearbejde eller tungt fritidsarbejde, hører du også til denne gruppe Du dyrker konkurrenceidræt svømning, fodbold eller
langdistanceløb flere gange om ugen

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33 Hvordan synes du, dit helbred er alt i alt?
Sæt kun markering i én af cirklerne

Side 7

Løbenummer

Fremragende Vældig godt Godt Mindre godt Dårligt 34 Sammenlignet med for ét år siden, hvordan er dit helbred alt i alt nu?
Sæt kun markering i én af cirklerne

Meget bedre nu end for ét år siden Noget bedre nu end for ét år siden Nogenlunde det samme Noget dårligere nu end for ét år siden Meget dårligere nu end for ét år siden

35 De følgende spørgsmål handler om aktiviteter i dagligdagen Er du på grund af dit helbred

begrænset i disse aktiviteter? I så fald, hvor meget?
Sæt en markering i cirklen under det rigtige svar for hvert spørgsmål

Ja, meget begrænset a Krævende aktiviteter, som feks at løbe, løfte tunge ting, deltage i anstrengende sport b Lettere aktiviteter, såsom at flytte et bord, støvsuge eller cykle c At løfte eller bære dagligvarer d At gå flere etager op ad trapper e At gå én etage op ad trapper f At bøje sig ned eller gå ned i knæ g Gå mere end én kilometer h Gå nogle hundrede meter i Gå 100 meter

Ja, lidt begrænset

Nej, slet ikke begrænset

j Gå i bad eller tage tøj på
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Side 8

Løbenummer

Har du inden for de sidste 4 uger, haft nogen af følgende problemer med dit arbejde eller andre daglige aktiviteter på grund af dit fysiske helbred?
Sæt en markering i cirklen under det rigtige svar for hvert spørgsmål

JA a Jeg har skåret ned på den tid, jeg bruger på arbejde eller andre aktiviteter b Jeg har nået mindre, end jeg gerne ville c Jeg har været begrænset i hvilken slags arbejde eller andre aktiviteter, jeg har kunnet udføre d Jeg har haft besvær med at udføre mit arbejde eller andre aktiviteter fx krævede det en ekstra indsats 37

NEJ

Har du inden for de sidste 4 uger haft nogen af følgende problemer med dit arbejde eller andre daglige aktiviteter på grund af følelsesmæssige problemer?
Sæt en markering i cirklen under det rigtige svar for hvert spørgsmål

JA a Jeg har skåret ned på den tid, jeg bruger på arbejde eller andre aktiviteter b Jeg har nået mindre, end jeg gerne ville c Jeg har udført mit arbejde eller andre aktiviteter mindre omhyggeligt, end jeg pleje

NEJ

Inden for de sidste 4 uger, hvor meget har dit fysiske helbred eller følelsesmæssige problemer vanskeliggjort din kontakt med familie, venner, naboer eller andre?
Sæt kun
markering i én af cirklerne

Slet ikke Lidt Noget En hel del Virkelig meget 39

Hvor stærke fysiske smerter har du haft i de sidste 4 uger?
Sæt kun markering i én af cirklerne

Ingen smerter Meget lette smerter Lette smerter Middelstærke smerter Stærke smerter Meget stærke smerter
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Side 9

Løbenummer

40 Inden for de sidste 4 uger, hvor meget har fysisk smerte vanskeliggjort dit daglige arbejde

både arbejde udenfor hjemmet og husarbejde?
Sæt kun markering i én af cirklerne

Slet ikke Lidt Noget En hel del Virkelig meget 41 Disse spørgsmål handler om, hvordan du har haft det i de sidste 4 uger

Hvor stor en del af tiden i de sidste 4 uger:
Sæt en markering i cirklen under det rigtige svar for hvert spørgsmål Det meste af tiden En hel del af tiden Noget af tiden Lidt af tiden På intet tidspunkt

Hele tiden

a Har du følt dig veloplagt og fuld af liv? b Har du været meget nervøs? c Har du været så langt nede, at intet kunne opmuntre dig? d Har du følt dig rolig og afslappet? e Har du været fuld af energi f Har du følt dig trist til mode? g Har du følt dig udslidt? h Har du været glad og tilfreds? i Har du følt dig træt?

42 Inden for de sidste 4 uger hvor stor
del af tiden har dit fysiske helbred eller følelsesmæssige

problemer gjort det vanskeligt at se andre mennesker fx besøge venner, slægtninge osv?
Sæt kun markering i én af cirklerne

Hele tiden Det meste af tiden Noget af tiden Lidt af tiden På intet tidspunkt
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Side 10

Løbenummer

43 Hvor rigtige eller forkerte er de følgende udsagn for dit vedkommende?
Sæt en markering i cirklen under det rigtige svar for hvert udsagn

Helt rigtigt a Jeg bliver nok lidt lettere syg end andre b Jeg er lige så rask som enhver anden, jeg kender c Jeg forventer at mit helbred bliver dårligere d Mit helbred er fremragende

Overvejende rigtigt

Ved ikke

Overvejende forkert

Helt forkert

De næste spørgsmål handler om nervebetændelse

JA 44 Er dine ben og fødder ofte følelsesløse? 45 Har du nogensinde en brændende smerte i dine ben og fødder? 46 Er dine fødder meget følsomme for berøring? 47 Har du ofte haft en prikkende følelse i dine ben eller fødder? 48 Gør det ondt, når sengetøjet rører huden på dine ben eller arme?

NEJ

Hvis du har svaret ja til nogen af spørgsmålene 44-48
49 Er dine symptomer værre om natten? 50 Er du i stand til at mærke forskel på varmt og koldt vand,
når du går i bad? 51 Har du nogensinde fået amputeret en tå, en fod eller en del af underbenet?
Amputationer på grund af ulykke regnes ikke med

52 Har du nogensinde haft et åbent fodsår? 53 Har din læge nogensinde sagt til dig, at du har diabetisk nervebetændelse? 54 Føler du dig træt i hele kroppen det meste af tiden? 55 Gør det ondt i dine ben, når du går? 56 Kan du mærke dine fødder, når du går? 57 Er huden på dine fødder så tør, at den sprækker?
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Side 11

Løbenummer

De sidste spørgsmål handler om dit medicinforbrug umiddelbart før du fik konstateret diabetes

58 Tog du dagligt nogen form for medicin, der var ordineret af en læge ikke vitaminpiller og

andet kosttilskud umiddelbart før du fik konstateret diabetes?
Ja Nej

Hvis Ja, beder vi dig skrive navn på medicinen, grunden til at du tog den samt det årstal, hvor du startede med at tage medicinen

1 Medicin:
Grunden til at du tog medicinen: Hvornår startede du med at tage medicinen:
Årstal

2 Medicin:
Grunden til at du tog medicinen: Hvornår startede du med at tage medicinen:
Årstal

3 Medicin:
Grunden til at du tog medicinen: Hvornår startede du med at tage medicinen:
Årstal

4 Medicin:
Grunden til
at du tog medicinen: Hvornår startede du med at tage medicinen:
Skal ikke udfyldes Forbeholdt instituttet

Årstal

Mange tak fordi du tog dig tid til at udfylde skemaet
Skemaet indsendes snarest muligt i vedlagte portofrie svarkuvert
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2004

Side 1

Hvad er dit personnummer?

Sundhedspersonale har forskellige måder at omgås patienter på, og vi vil gerne vide noget om, hvordan du har haft det med sundhedspersonalet, når I har talt om din diabetes Dine svar bliver behandlet med fortrolighed Vi beder dig være ærlig og oprigtig Du bedes sætte én markering i firkanten under det svar, der bedst passer til din grad af enighed Arbejd hurtigt og besvar alle punkterne så godt du kan

Meget uenig

Noget uenig

Lidt uenig

Neutral

Lidt enig

Noget enig

Meget enig

2 Jeg føler, at sundhedspersonalet præsenterede mig for valg og muligheder med hensyn til at håndtere min diabetes 3 Jeg føler mig forstået af sundhedspersonalet med hensyn til min diabetes 4 Sundhedspersonalet udtrykker tillid til, at jeg kan foretage de ændringer, der er nødvendige for at styre min diabetes 5 Sundhedspersonalet opmuntrer

mig til at stille spørgsmål om min diabetes
6
Sundhedspersonalet prøver at forstå, hvordan jeg ser på min diabetes, inden de foreslår en ny måde at gøre tingene på

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Side 2

Der er mange forskellige grunde til, at patienter tager deres medicin, checker deres blodsukker, følger deres diæt eller motionerer regelmæssigt Vi beder dig overveje følgende udsagn og angive, i hvor høj grad du er enig eller uenig i hvert udsagn ved hjælp af skalaen herunder

A Jeg tager min diabetesmedicin og/eller måler mit blodsukker, fordi:

Meget uenig

Noget uenig

Lidt uenig

Neutral

Lidt enig

Noget enig

Meget enig

7 Andre mennesker ville blive vrede på mig, hvis jeg ikke gjorde det 8 Det er en personlig udfordring for mig at gøre det 9 Jeg ved egentlig ikke hvorfor jeg prøver, det nytter alligevel ikke 10 Jeg tror personligt, at mit helbred vil forbedres, hvis jeg har min diabetes under kontrol 11 Jeg ville føle skyld, hvis jeg ikke gjorde, som min læge siger

12 Jeg vil gerne have, at min læge synes, jeg er en god patient 13 Jeg ville have det dårligt med mig selv, hvis jeg ikke gjorde det

14 Det er spændende at prøve at holde mit blodsukker inden for et område, der er godt for mit helbred 15 Jeg
ønsker ikke, at andre mennesker skal blive skuffede over mig

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Side 3

B Grunden til, at jeg følger min diæt og motionerer regelmæssigt, er at:
Meget uenig Noget uenig Lidt uenig Lidt enig Noget enig Meget enig

Neutral

16 Jeg ville gøre andre kede af det, hvis jeg ikke gjorde det 17 Jeg tror personligt på, at disse forhold er vigtige for at forblive sund og rask 18 Jeg ville skamme mig over mig selv, hvis jeg ikke gjorde det 19 Det er lettere at gøre, hvad jeg får besked på, end selv at skulle tænke over det 20 Jeg har tænkt grundigt på at følge min diæt og motionere og tror på, at det er det rigtige at gøre 21 Jeg vil gerne have, at andre skal se, at jeg kan følge min diæt og holde mig i god form 22 Jeg ved ikke hvorfor Jeg gør det vel kun, fordi min læge har sagt, at jeg skal 23 Jeg føler personligt, at det er bedst for mig at være opmærksom på min diæt og motion 24 Jeg ville føle skyld, hvis jeg ikke var opmærksom på min diæt og motion 25 Regelmæssig motion og overholdelse af diæt er valg, jeg virkelig ønsker at træffe 26 Det er en udfordring at lære, hvordan man lever med diabetes 27 Jeg er ikke sikker på, hvorfor jeg egentlig overholder
min diæt eller motionerer regelmæssigt; jeg må vente og se tiden an
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Side 4

De næste spørgsmål handler om dine betragtninger vedrørende din diabetes Vi er interesseret i dit eget, personlige syn på, hvordan du opfatter din diabetes nu
Sæt èn markering firkanten ud for hvert udsagn, der viser i hvor høj grad du er enig eller uenig i de følgende udsagn

Meget enig 28 En bakterie eller virus er skyld i min diabetes 29 Kost spillede en stor rolle for udviklingen af min diabetes 30 Miljøforurening er skyld i min diabetes 31 Min diabetes er arvelig - det ligger til familien 32 Det var bare et tilfælde, at jeg blev syg 33 Stress var en vigtig faktor for udviklingen af min diabetes 34 Min diabetes skyldes overvejende min egen adfærd 35 Andre mennesker spillede en stor rolle for udviklingen af min diabetes 36 Min diabetes skyldes dårlig lægelig behandling i fortiden 37 Min sindstilstand spillede en stor rolle for udviklingen af min diabetes 38 Min diabetes vil vare i kort tid 39 Min diabetes vil snarere være permanent end midlertidig 40 Min diabetes vil vare i lang tid 41 Mit liv vil blive kortere, fordi jeg har diabetes 42 Min diabetes vil hurtigt gå
over 43 Jeg forventer at have diabetes resten af livet 44 Min diabetes er en alvorlig trussel mod mit helbred

Enig

Hverken enig eller uenig

Uenig

Meget uenig

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Side 5

Sæt èn markering firkanten ud for hvert udsagn, der viser i hvor høj grad du er enig eller uenig i de følgende udsagn

Meget enig 45 Min diabetes har haft store konsekvenser for mit liv 46 Jeg har kun diabetes i mild grad 47 Jeg er bekymret for at udvikle diabeteskomplikationer 48 Min diabetes vil ikke få stor indflydelse på mit liv 49 Min diabetes vil i høj grad påvirke andre menneskers opfattelse af mig 50 Det vil ikke påvirke mit helbred at have diabetes 51 Jeg vil sandsynligvis udvikle diabeteskomplikationer 52 Min diabetes har alvorlige økonomiske konsekvenser 53 Min diabetes vil ændre mine dagelige aktiviteter venner, arbejde, skole 54 Min diabetes vil i høj grad påvirke min opfattelse af mig selv som menneske

Enig

Hverken enig eller uenig

Uenig

Meget uenig

55 Vær venlig at skrive de diabeteskomplikationer du kender til Nævn så mange, du kan komme i tanker om Skriv med blokbogstaver

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Side 6

56 Hvor STOR BETYDNING har hvert
af følgende punkter haft for, at du har din diabetes under kontrol?
Sæt en markering i den firkant ud for hvert spørgsmål, der bedst beskriver dine følelser Særdeles stor Ingen Lille Nogen Stor betydning betydning betydning betydning betydning

Regelmæssig motion? Ikke at ryge? Regelmæssig måling af dit blodsukker? Holde regnskab med resultaterne af dine blodsukkermålinger? At følge din kostplan? Ikke at spise for mange søde sager? At tage din medicin/insulin som ordineret? Kun at drikke lidt eller ingen alkohol? At gøre som anbefalet de dage, hvor du er syg?

57 Hvor SANDSYNLIGT er det, at hvert af følgende punkter kan hjælpe med til at forebygge diabeteskomplikationer i fremtiden?
Sæt en markering i den firkant ud for hvert spørgsmål, der bedst beskriver dine følelser Ikke Lidt Noget Meget Højst sandsynligt sandsynligt sandsynligt sandsynligt sandsynligt

Regelmæssig motion? Ikke at ryge? Regelmæssig måling af dit blodsukker? Regelmæssig undersøgelse af dine fødder? Holde regnskab med resultaterne af dine blodsukkermålinger? At følge din kostplan? Ikke at spise for mange søde sager? At tage din medicin/insulin som ordineret? Kun at drikke lidt eller ingen alkohol? At gøre som
anbefalet de dage, hvor du er syg? Sikre, at du bliver undersøgt regelmæssigt for diabetesrelaterede følgesygdomme fx øjenus
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2004

Side 7

De næste spørgsmål handler om hvilke råd du har modtaget af dit behandlingsteam

Hvilke af følgende råd har dit behandlingsteam læge, sygeplejerske, diætist eller diabetesskole givet dig? Sæt gerne flere markeringer At følge en fedtfattig kostplan At følge en diæt sammensat af kylhydrater, der optages langsomt Fx kartofter, ris, pasta og lign At reducere dit kalorieindtag for at tabe dig At spise masser af fiberrig mad At spise masser af frugt og grønsager mindst 5 om dagen At spise meget få søde sager fx desserter, ikke-sukkerfri sodavand, chokolade Du har ikke fået nogen kostråd af dit behandlingsteam Andet Beskriv:
Skal ikke udfyldes Forbeholdt kodning

Hvilke af følgende råd har dit behandlingsteam læge, sygeplejerske, diætist eller diabetesskole givet dig? Sæt gerne flere markeringer Dagligt at dyrke let motion fx at gå en tur Motionere uafbrudt i mindst 20 minutter mindst 3 gange om ugen Indpasse motion i dine dagelige vaner Fx at tage trappen i stedet for elevatoren, parkere et stykke
fra dit
bestemmelsessted og gå, osv

At dyrke en bestemt mængde motion af en bestemt type og varighed og på et bestemt niveau Du har ikke fået nogen motionsråd af dit behandlingsteam Andet Beskriv
Skal ikke udfyldes Forbeholdt kodning

Hvilke af følgende råd har dit behandlingsteam læge, sygeplejerske, diætist eller diabetesskole givet dig? Sæt gerne flere markeringer At måle dit blodsukker ved hjælp af en dråbe blod fra fingeren At måle dit blodsukker ved hjælp af et apparat, der kan aflæse resultaterne At undersøge om du har sukker i urinen Du har ikke fået nogen råd om hverken at undersøge dit blod eller urin af dit behandlingsteam Andet Beskriv
Skal ikke udfyldes Forbeholdt kodning

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Spørgeskema tid 12 måneder
2004

Side 8

Hvilke af følgende former for medicin har din læge ordineret for din diabetes?
Sæt kun én markering

En insulinindsprøjtning 1 eller 2 gange dagligt En insulinindsprøjtning 3 eller flere gange dagligt Tabletter til at holde din blodsukkerværdi under kontrol Du har ikke fået ordineret hverken insulin eller tabletter for din diabetes Andet Beskriv:
Skal ikke udfyldes Forbeholdtkodning

Medicin
Du bedes sætte en cirkel om det tal på skalaen, du synes
passer bedst med din vurdering

Hvor mange dage ud af de sidste SYV DAGE har du taget din anbefalede diabetesmedicin?

0
63

Dage

Hvor mange dage ud af de sidste SYV DAGE har du taget dine anbefalede insulinindsprøjtninger? 0 1 2 3 4 5 6 7 Dage Hvor mange dage ud af de sidste SYV DAGE har du taget dit anbefalede antal diabetestabletter?

Dage

Fodpleje
Du bedes sætte en cirkel om det tal på skalaen, du synes passer bedst med din vurdering

Hvor mange dage ud af de sidste SYV DAGE har du vasket dine fødder?

0
66

Dage

Hvor mange dage ud af de sidste SYV DAGE har du taget et fodbad?

0
67

Dage

Hvor mange dage ud af de sidste SYV DAGE har du tørret dig mellem tæerne efter at have vasket dem?

Dage
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Side 9

Rygning 68 Har du røget - endog bare et sug - i løbet af de sidste SYV DAGE? Nej Ja

Antal
Hvis ja, hvor meget ryger du i gennemsnit om dagen? cigaretter dagligt? cerutter dagligt? cigarer dagligt? gram pibetobak om ugen?

Hvis ja, blev du spurgt om dine rygevaner ved dit sidste lægebesøg?

Nej

Blev du rådet
til at holde op med at ryge eller henvist til et rygestopkursus ved dit sidste lægebesøg? Nej Ja

Hvornår har du sidst røget? Sæt kun én markering For mere end to år siden, eller har aldrig røget For et til to år siden For fire til tolv måneder siden For en til tre måneder siden Inden for den sidste måned I dag

Hvor meget ønsker du at holde op med at ryge? Sæt kun én markering Virkelig meget Meget Kun lidt Slet ikke

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Side 10

72 Hvor meget øl, vin og spiritus drikker du i gennemsnit på en almindelig uge?
skriv 0, hvis det er mindre end én genstand om ugen

Antal flasker Almindelig pilsnerøl Stærk øl? Rød eller hvidvin? Hedvin, feks sherry, portvin? Spiritus, feks snaps, whisky? eller eller eller Antal glas ca 6 glas pr flaske ca 9 glas pr flaske 1 glas 4 centiliter

73 Føler du, at du af hensyn til dit helbred burde nedsætte dit forbrug af alkohol øl, vin, spiritus? Ja Nej

74 Hvilken beskrivelse passer bedst på dig? Jeg spiser nogenlunde som gennemsnittet Jeg spiser mere sundt end de fleste Jeg spiser nok lidt mere usundt end de fleste Jeg spiser temmelig usundt

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Spørgeskema tid 12 måneder
2004

Side 11

De næste spørgsmål
handler om fysisk aktivitet
Hård fysisk aktivitet er en aktivitet, der kræver stor fysisk anstrengelse og gør din vejrtrækning meget hurtigere end normalt Moderat fysisk aktivitet er en aktivitet, der kræver en moderat fysisk anstrengelse og gør din vejrtrækning noget hurtigere end normalt Sammentællingen af den tid timer/minutter du har brugt på henholdvis hård fysisk aktivitet spm 75 a, moderat fysisk aktivitet spm 76 a, gåture spm 77 a, at sidde ned spm 78 og at sove spm 79 bør være 24 timer

75 Hvor mange dage i løbet af de sidste 7 dage har du været i hård fysisk aktivitet, som feks tunge løft, gravearbejde, konditræning eller hurtig cykling? Tænk kun på de aktiviteter, du udførte
mindst 10 minutter ad gangen

Ingen Dage Gå til a a Hvor meget tid brugte du i gennemsnit på hård fysisk aktivitet i løbet af 24 timer én af disse dage? Timer Minutter

Igen skal du kun tænke på den fysiske aktivitet du udførte mindst 10 minutter ad gangen

Hvor mange dage i løbet af de sidste 7 dage har du været i moderat fysisk aktivitet, som feks at løfte lettere ting, cykle i jævnt tempo eller spille en double i tennis? Gåture skal ikke medregnes Ingen Dage Gå til a a Hvor meget tid brugte
du i gennemsnit på moderat fysisk aktivitet i løbet af 24 timer én af disse dage? Timer Minutter

Hvor mange dage i løbet af de sidste 7 dage har du gået i mindst 10 minutter ad gangen? Medregn gåture til og fra arbejdet, gåture for at komme fra et sted til et andet og alle andre gåture, som du foretog i forbindelse med fornøjelse, sport, motion eller fritid Ingen Dage Gå til a a Hvor megen tid brugte du i gennemsnit på at gå i løbet af 24 timer én af disse dage? Timer Minutter
62215

Spørgeskema tid 12 måneder
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Side 12

78 Hvor lang tid sidder du ned på hverdage, både når du er på arbejde, hjemme, på kursus og i fritiden Medregn den tid du sidder ved et skrivebord, besøger venner, læser, kører i bus eller sidder eller ligger, mens du ser fjernsyn I løbet af de sidste 7 dage, hvor lang tid har du i gennemsnit siddet ned i løbet af et døgn 24 timer? Timer Minutter

79 I løbet af de sidste 7 dage, hvor lang tid har du i gennemsnit sovet eller ligget ned i løbet af et døgn 24 timer? Timer Minutter

80 Har du beskæftigelse?

Nej gå til spørgsmål 82

81 Hvis ja, hvilken af følgende grupper mener du selv, at du tilhører på din arbejdsplads?
Sæt kun én markering

Jeg sidder
for det meste ned og går ikke ret meget omkring på arbejdspladsen
feks skrivebordsarbejde, samle smådele og lignende

Jeg går en del omkring på arbejdspladsen uden at skulle slæbe på tunge ting
feks lettere industriarbejde, ikke stillesiddende kontorarbejde, husligt arbejde, undervisning og lign

Jeg går for det meste og må ofte gå op ad trapper og løfte forskellige ting
feks postombæring, byggearbejde, flytte tunge møbler og lignende

Jeg har legemligt arbejde, løfter tunge ting og anstrenger mig fysisk
feks gravearbejde, skovarbejde, jord- og betonarbejde og lignende

82 Hvor mange dages sygefravær har du haft inden for de sidste 4 arbejdsuger? Benyt gerne din kalender
Sygefravær er hvor du bliver hjemme fra arbejde på grund af sygdom Sygefravær pga lægebesøg, hospitalsindlæggelse, fysioterapi, kiropraktisk behandling, alternativ behandling og lignende skal ikke tælles med Sygefravær pga børns eller øvrig families sygdom skal heller ikke tælles med

Jeg har haft

dages sygefravær fra mit arbejde/uddannelse

83 Hvilken af følgende grupper mener du selv, at din fritidsbeskæftigelse omfatter? Jeg sidder som regel og læser, ser fjernsyn, går i biografen og tilbringer fritiden med
stillesiddende sysler Jeg går tur, kører lidt på cykel eller er i legemlig aktivitet mindst 4 timer om ugen lettere
fritidsbyggeri, husligt arbejde, bordtennis og bowling

Jeg er aktiv idrætsudøver mindst 3 gange ugentligt Hvis du ikke dyrker sport, men ofte
udfører tungt havearbejde eller tungt fritidsarbejde, hører du også til denne gruppe

Jeg dyrker konkurrenceidræt eller langdistanceløb flere gange om ugen

Mange tak for hjælpen

62215

Spørgsmål til alle læger i interventionsgruppen
ADDITION Spørgeskema 2/SR-SM Juni 2002

Side 1

Eksempel på en case, som du møder i din praksis: Tænk på en patient med type 2-diabetes og høj kardiovaskulær risiko 40 ifølge DSAMs Hjertevejledning, som du har forsøgt at behandle i 1 år uden effekt på risikoprofilen Hvad gør du i følgende situationer?

1 Hvad vil du gøre, når patienten åbenlyst ikke vil følge dine råd?
Helt enig Lidt enig Hverken enig eller uenig Lidt uenig Helt uenig

a Forklare behandlingsplanen igen b Orientere dig yderligere om patientens evner og muligheder for at løse problemet c Forklare hvorfor det er vigtigt at følge behandlingsplanen med saglige argumenter d Undersøge om patienten tror på, at de planlagte tiltag vil
gavne patienten selv

e Få patienten til at redegøre for fordele og ulemper ved aktuel adfærd i forhold til sygdom og behandlingstiltag

Informere yderligere for at overtale patienten til en aftale

g Fremhæve hvad konsekvenserne bliver, hvis planen ikke overholdes

Få patienten til at resumere aftalen

Spørge om hvilke forventningerer patienten har til, hvad du kan gøre i den aktuelle situation

Af mulighederne a - i nævn de 3, som du finder væsentligst

43806

Spørgsmål til alle læger i interventionsgruppen
ADDITION Spørgeskema 2/SR-SM Juni 2002

Side 2

2 Hvad vil du gøre, når du har på fornemmelsen, at patienten ikke vil følge dine råd?
Helt enig a b Forklare behandlingsplanen igen Orientere dig yderligere om patientens evner og muligheder for at løse problemet Forklare hvorfor det er vigtigt at følge behandlingsplanen med saglige argumenter Undersøge om patienten tror på, at de planlagte tiltag vil gavne patienten selv Få patienten til at redegøre for fordele og ulemper ved aktuel adfærd i forhold til sygdom og behandlingstiltag Informere yderligere for at overtale patienten til en aftale Fremhæve hvad konsekvenserne bliver, hvis planen ikke overholdes Få patienten
til at resumere aftalen Lidt enig Hverken enig eller uenig Lidt uenig Helt uenig

c d e

f g h i

Spørge om hvilke forventningerer patienten har til, hvad du kan gøre i den aktuelle situation Af mulighederne a - i nævn de 3, som du finder væsentligst

3 Hvad vil du gøre, når patientens egne mål fx ønsket om et godt helbred, ikke stemmer overens med patientens adfærd? Hverken
Helt enig Lidt enig enig eller uenig Lidt uenig Helt uenig

a b

Forklare behandlingsplanen igen Orientere dig yderligere om patientens evner og muligheder for at løse problemet Forklare hvorfor det er vigtigt at følge behandlingsplanen med saglige argumenter Undersøge om patienten tror på, at de planlagte tiltag vil gavne patienten selv Få patienten til at redegøre for fordele og ulemper ved aktuel adfærd i forhold til sygdom og behandlingstiltag Informere yderligere for at overtale patienten til en aftale Forhæve hvad konsekvenserne bliver, hvis planen ikke overholdes Få patienten til at resumere aftalen Spørge om hvilke forventningerer patienten har til, hvad du kan gøre i den aktuelle situation

d e

f g h i

Af mulighederne a - i nævn de 3, som du finder væsentligst
43806

Spørgsmål til alle læger i
interventionsgruppen
ADDITION Spørgeskema 2/SR-SM Juni 2002

Side 3

4 Hvad mener du er afgørende for, hvad patienten vælger at gøre?
Helt enig a b c d e f g h At der er tillid mellem dig og patienten At patienten grundigt forklares om argumenter for planen At du informerer mest muligt At du som læge lægger en klar plan for patienten At patienten er informeret om konsekvenserne af manglende handling At patienten selv kommer med løsningsforslag At patienten selv vælger en behandlingsplan blandt dine forslag At patienten kan udtrykke sin opfattelse af sygdomssituationen og sin forståelse for behandlingsplanen Lidt enig Hverken enig eller uenig Lidt uenig Helt uenig

Af mulighederne a - h nævn de 3, som du finder væsentligst

5 Hvilke muligheder anvender du for at motivere en patient til ændring af adfærd?
Altid a b Aktiv lytning Forbereder patienten på behandlingsmuligheder inden valg af løsning på problemet Klare argumenter for ændring af adfærden, som tydeliggør konsekvenserne af fortsat uændret adfærd Klargør for patienten hvad strategien er i forhold til tidsaspektet Fremhæver patientens ressourcer Klargør hvilke fordele og ulemper patienten selv opfatter ved sygdommen og
behandlingsplanen Viser patienten empati, støtte og respekt Fokuserer på det positive ved patientens adfærd i forhold til sygdomsforløb Ofte Ind imellem Sjældent Aldrig

d e f

g h

Af mulighederne a - h nævn de 3, som du finder væsentligst

43806

Spørgsmål til alle læger i interventionsgruppen
ADDITION Spørgeskema 2/SR-SM Juni 2002

Side 4

6 Hvad er for dig Den vanskelige patient?
Helt enig a Det er patienten, der kommer igen og igen med det samme problem, som der ikke er nogen løsning på fx diabetespatienten med dårligt reguleret sukkersyge, der mener, at der må være noget medicin, der er mere effektivt b Det er patienten, der kommer igen og igen fordi hun ikke gør det, der skal til for at løse problemet, men forventer, at du løser hendes problemer fx diabetespaienten, der fortsætter med at spise usundt og ikke taber i vægt c Det er patienten, der altid er skeptisk og kun er optaget af, hvorfor det er umuligt at gennemføre de handlinger/adfærdsændringer, der skal til fx diabetespatienten, der gerne til have hjælp til at holde op med at spise usundt, men afviser alle dine forsøg på at hjælpe d Det er patienten, som slet ikke selv kan forstå, at der en sammenhæng mellem adfærd
og problemer fx diabetespatienten, der er helt afvisende overfor tanken om, at hendes ustabile blodsukker ved kontrol kan have noget med hendes usunde spisevaner at gøre e Andre? Beskriv situationen Lidt enig Hverken enig eller uenig Lidt uenig Helt uenig

Skal ikke udfyldes Forbeholdt kodning

7 Havde du forud for ADDITION-projektet kendskab til principperne i Den Motiverende Samtale? Nej Ja, fra DSAMs bog Den motiverende samtale Ja, fra Ugeskrift for Læger Ja, fra Månedsskrift for Praktisk Lægegerning Ja, fra andre kurser Andet? Hvis ja Angiv hvorfra:
Skal ikke udfyldes Forbeholdt kodning

43806

Spørgsmål til alle læger i interventionsgruppen
ADDITION Spørgeskema 2/SR-SM Juni 2002

Side 5

Havde du forud for kurset kendskab til de teknikker, der er forbundet med Den Motiverende Samtale? Nej Ja, men jeg havde ikke anvendt disse teknikker i praksis Ja, men jeg havde kun anvendt disse teknikker i begrænset omfang Ja, disse teknikker indgik i min daglige patientbehandling

Ja, i høj grad

Nogenlunde

Hverken / eller

I Nej begrænset overhovedet omfang ikke

Har du efter kurset dannet dig et overblik over metoderne i Den Motiverende Samtale?

10 Føler du dig efter kurset rustet
til at anvende Den Motiverende Samtale i praksis? 11 Er Den Motiverende Samtale i praksis realistisk?

12 Hvad er din opfattelse af metoderne i Den Motiverende Samtale?
Helt enig a b c De er generelt særdeles velegnede til brug i almen praksis De er kun egnede til specielle situationer/ patienter De er mere effektive end traditionel information og rådgivning De er for tidsrøvende Patienterne vil have, at lægen fortæller, hvad der skal gøres Det er svært at ændre mine indøvede rutiner og metoder Jeg har ikke haft patienter, der passer til Den Motiverende Samtale Lidt enig Hverken enig eller uenig Lidt uenig Helt uenig

d e f

43806

Spørgsmål til alle læger i interventionsgruppen
ADDITION Spørgeskema 2/SR-SM Juni 2002

Side 6

13 Har du efter kurset anvendt nogle teknikker fra Den Motiverende Samtale? Nej
Gå til spørgsmål 14

Ja, jeg har anvendt en eller flere af følgende teknikker, beskrevet i 13a - 13g: 13a PEARLS Partnerskab, Empati, Accept, Respekt, Legitimering, Støtte Nej
Hvis ja, hvor ofte anvender du PEARLS?

Altid Ofte Indimellem Sjældent Aldrig
Hvis ja, er du enig i, at metoden er velegnet til almen praksis?

Helt enig Lidt enig Hverken enig eller uenig Lidt uenig
Helt uenig

13b AKTIV LYTTEN

Nej

Hvis ja, hvor ofte anvender du AKTIV LYTTEN?

Altid Ofte Indimellem Sjældent Aldrig
Hvis ja, er du enig i, at metoden er velegnet til almen praksis?

Helt enig Lidt enig Hverken enig eller uenig Lidt uenig Helt uenig

43806

Spørgsmål til alle læger i interventionsgruppen
ADDITION Spørgeskema 2/SR-SM Juni 2002

Side 7

13c DEN VISUELLE ANALOGSKALA

Nej

Hvis ja, hvor ofte anvender du DEN VISUELLE ANALOGSKALA?

Altid Ofte Indimellem Sjældent Aldrig
Hvis ja, er du enig i, at metoden er velegnet til almen praksis?

Helt enig Lidt enig Hverken enig eller uenig Lidt uenig Helt uenig

13d FORANDRINGENS HJUL

Nej

Hvis ja, hvor ofte anvender du FORANDRINGENS HJUL?

Altid Ofte Indimellem Sjældent Aldrig
Hvis ja, er du enig i, at metoden er velegnet til almen praksis?

Helt enig Lidt enig Hverken enig eller uenig Lidt uenig Helt uenig

43806

Spørgsmål til alle læger i interventionsgruppen
ADDITION Spørgeskema 2/SR-SM Juni 2002

Side 8

13e BALANCESKEMAET opstilling af fordele og ulemper ved at fortsætte adfærd

Nej

Hvis ja, hvor ofte anvender du BALANCESKEMAET?

Altid Ofte Indimellem Sjældent Aldrig
Hvis ja, er du enig i, at metoden er
velegnet til almen praksis?

Helt enig Lidt enig Hverken enig eller uenig Lidt uenig Helt uenig

13f ROKKE VED AMBIVALENSEN

Nej

Hvis ja, hvor ofte anvender du AT ROKKE VED AMBIVALENSEN?

Altid Ofte Indimellem Sjældent Aldrig
Hvis ja, er du enig i, at metoden er velegnet til almen praksis?

Helt enig Lidt enig Hverken enig eller uenig Lidt uenig Helt uenig

43806

Spørgsmål til alle læger i interventionsgruppen
ADDITION Spørgeskema 2/SR-SM Juni 2002

Side 9

13g EMPOWERING / ROS

Nej

Hvis ja, hvor ofte anvender du EMPOWERING / ROS?

Altid Ofte Indimellem Sjældent Aldrig
Hvis ja, er du enig i, at metoden er velegnet til almen praksis?

Helt enig Lidt enig Hverken enig eller uenig Lidt ueig Helt uenig

Helt enig 14 Den Motiverende Samtale er bedre end mine nuværende arbejdsmetoder 15 Jeg kan ikke omstille mine indarbejdede rutiner og implementere Den Motiverende Samtale 16 Det kan betale sig at skifte abejdsmetode 17 De pædagogiske redskaber / teknikker fra kurset hjælper mig i patientbehandlingen 18 Har du oplevet, at samtalen flyttede noget konkret ved patientens adfærd? Beskriv:

Lidt enig

Hverken enig eller uenig

Lidt uenig

Helt uenig

Skal ikke udfyldes Forbeholdt
kodning

19 Hvad skal der til, for at du vil anvende Den Motiverende Samtale i større omfang? Beskriv:
Skal ikke udfyldes Forbeholdt kodning

Mange tak for hjælpen

43806

Appendix D

Registreringsblanket for praktiserende læger CRF 4: Tid 0
Ydernummer: Patientens personnummer: Lægeinitialer:

Løbenummer

Dag Måned

Dato:

-200
År

Blodtryk:

- Personen skal være siddende og have været hvilende i 10 minutter - Hvis BT 120/80 gentages BT efter 5 minutter Skriv det lavest målte BT - Der anvendes en bred manchet, hvis omkredsen af armen 32 cm

Systolisk

Diastolisk

Vægt:

Personen vejes uden overtøj eller sko

Fodundersøgelse:

Højre fod Ja Nej

Venstre fod Ja Nej

Er der sår på:

Medicin:
Notér navn og mængde på den medicin, som patienten har indtaget dagligt gennem den sidste måned

1 2 3 4 5
Hvis patienten får mere medicin, fortsæt på bagsiden Forbeholdt instituttet

Tobaksoplysninger:

Patienten ryger ikke Cigaretter Cigarer/cerutter Patienten ryger pibe Antal pr dag Antal pr dag Pakker 50 g pr uge
14991

Registreringsblanket for praktiserende læger CRF 4: Tid 0

Løbenummer

Til patienten

INFORMERET SAMTYKKE

Jeg accepterer deltagelse i projektet som beskrevet i
udleveret brev Jeg kan til enhver tid trække min deltagelse tilbage, uden at dette på nogen måde vil forringe forholdet til min praktiserende læge eller påvirke dennes undersøgelse eller behandling af mig i negativ retning

Mit cprnr:

Dato

Underskrift

14991

Registreringsblanket for læger CRF 6: Tid 6 måneder

Interventionsgruppen Side 1

Løbenummer

Ydernummer:

Lægeinitialer:

Patientens personnummer:

Dag Måned

Dato:

-200
År

rBG:
og/eller

, , ,

mmol/l

Blodglukose måles på kapillært blod og analyseres ved brug af HemoCue-apparat

fBG:

mmol/l

Blodglukose måles på kapillært blod og analyseres ved brug af HemoCue-apparat

HbA1c:

Blodtryk:

Systolisk

Diastolisk

Vægt:

Personen vejes uden overtøj eller sko

Hvor mange gange har patienten haft hypoglykæmifølinger inden for den sidste uge
symptomer på hypoglykæmi, hvor patienten kunne klare situationen selv ved at drikke eller spise noget?

antal gange

Hvor mange gange har patienten i løbet af de sidste 4 uger
haft så svær hypoglykæmi, at det krævede hjælp fra andre?

antal gange
9408

Registreringsblanket for læger CRF 6: Tid 6 måneder

Interventionsgruppen Side 2

Løbenummer

Hvilken behandling får patienten? 1 Diæt 2 Oral diabeticum Hvis Ja, navn og dosering:
1 2 3

Nej Nej

Ja Ja,
Døgndosis
ATC-kode
Skal ikke udfyldes Forbeholdt instituttet

, , ,
Nej Ja,
Døgndosis

mg mg mg
Skal ikke udfyldes Forbeholdt instituttet

3 Insulin Hvis Ja, type og dosering:

ATC-kode

1 2 3

IE IE IE

4 Antihypertensiva Hvis Ja, type og dosering:

Nej

Ja,
Døgndosis ATC-kode

Skal ikke udfyldes Forbeholdt instituttet

1 2 3

, , ,
Nej Ja,
Døgndosis

mg mg mg
Skal ikke udfyldes Forbeholdt instituttet

5 Lipidsænkende medicin Hvis Ja, type og dosering:
1 2 3

ATC-kode

mg mg mg

9408

Registreringsblanket for læger CRF 6: Tid 6 måneder
6 Antitrombotica Hvis Ja, navn og dosering: Nej

Interventionsgruppen Side 3

Løbenummer

Ja,
Døgndosis ATC-kode

1 2 3

mg mg mg

Skal ikke udfyldes Forbeholdt instituttet

Tobaksoplysninger:

Patienten ryger ikke Cigaretter Cigarer/cerutter Patienten ryger pibe Antal pr dag Antal pr dag Pakker 50 g pr uge

Er der ved denne konsultation

Ja Generel information om Type 2
diabetes? Mad og alkohol? Motion? Tobaksophør? Den diabetiske fod? Insulinbehandling? Andet materiale?
Skriv venligst hvilket

Talt om

Nej

Medgivet pt pjecer om

Nej

Har patienten ved denne konsultation lånt videoen
Fedt nok Mads og Birte

Nej

9408

Registreringsblanket for læger CRF 8: Tid 1 år
Ydernummer: Patientens personnummer:

Interventionsgruppen Side 1

Løbenummer

Lægeinitialer:

Dag Måned

Dato:

-200
År

rBG:
og/eller

, , ,

mmol/l

Blodglukose måles på kapillært blod og analyseres ved brug af HemoCue-apparat

fBG: HbA1c:

mmol/l

Blodglukose måles på kapillært blod og analyseres ved brug af HemoCue-apparat

Blodtryk:

Systolisk

Diastolisk

Vægt:

Personen vejes uden overtøj eller sko kg

Hvor mange gange har patienten haft hypoglykæmifølinger inden for den sidste uge
symptomer på hypoglykæmi, hvor patienten kunne klare situationen selv ved at drikke eller spise noget?

antal gange

Hvor mange gange har patienten i løbet af de sidste 4 uger haft så svær
hypoglykæmi, at det krævede hjælp fra andre?

antal gange

Fodundersøgelse:

Højre fod Ja Nej

Venstre fod Ja Nej

Er der sår på:
19287

Registreringsblanket for læger CRF 8: Tid 1 år
Hvilken behandling får patienten? 1 Diæt 2 Oral diabeticum Hvis Ja, navn og dosering:
1 2 3

Interventionsgruppen Side 2

Løbenummer

Nej Nej

Ja Ja,
Døgndosis ATC-kode
Skal ikke udfyldes Forbeholdt instituttet

, , ,
Nej Ja,
Døgndosis

mg mg mg
Skal ikke udfyldes Forbeholdt instituttet

3 Insulin Hvis Ja, type og dosering:

ATC-kode

1 2 3

IE IE IE

4 Antihypertensiva Hvis Ja, type og dosering:

Nej

Ja,
Døgndosis ATC-kode

Skal ikke udfyldes Forbeholdt instituttet

1 2 3

, , ,
Nej Ja,
Døgndosis

mg mg mg

Lipidsænkende medicin Hvis Ja, type og dosering:
1 2 3

ATC-kode

Skal ikke udfyldes Forbeholdt instituttet

mg mg mg
19287

Registreringsblanket for læger CRF 8: Tid 1 år

Interventionsgruppen Side 3

Løbenummer

6 Antitrombotica Hvis Ja, navn og dosering:

Nej

Ja,
Skal ikke udfyldes Forbeholdt instituttet

Døgndosis

ATC-kode

1 2 3

mg mg mg

Tobaksoplysninger:
Patienten ryger ikke Cigaretter Cigarer/cerutter Patienten ryger pibe Antal pr dag Antal pr dag Pakker 50 g pr
uge

19287

Source:gha.org

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