Improving Patient Care

MICHEL WENSING, Full Professor of Health Services Research and Implementation Science, University of Heidelberg, Heidelberg; Department of General Practice and Health Services Research, Heidelberg University Hospital, Heidelberg, Germany; Department IQ healthcare, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands. RICHARD GROL, Emeritus Professor, Radboud University, Nijmegen; and Maastricht University, Maastricht, The Netherlands. JEREMY GRIMSHAW, Senior Scientist, Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario; Full Professor, Department of Medicine, University of Ottawa, Ottawa, Ontario; Canada Research Chair in Health Knowledge Transfer and Uptake, Ottawa, Ontario, Canada.

List of Contributors xv

Introduction xix

Part I Principles of the Implementation of Change 1

1 Implementation of Change in Healthcare: A Complex Problem 3
Richard Grol and Michel Wensing

1.1 Introduction 3

1.2 The Implementation Problem 5

1.2.1 Effective Care 6

1.2.2 Safe Care 6

1.2.3 Efficient Care 7

1.2.4 Access to Care 8

1.2.5 Patient-Centered Care 8

1.2.6 Variation in the Provision of Care 8

1.3 Various Approaches to the Implementation of Change in Patient Care 9

1.4 What is Implementation? 12

1.5 Which Recommended Practices Should Be Adopted? 15

1.5.1 New Insights and Technologies 15

1.5.2 Problems in Healthcare Practice 16

1.6 A Systematic Approach to “Sustainable Change” 16

References 17

2 Theories on Implementation of Change in Healthcare 21
Michel Wensing and Richard Grol

2.1 Introduction 21

2.2 Theories on Factors Related to Individual Professionals 23

2.2.1 Cognitive Theories 23

2.2.2 Educational Theories 25

2.2.3 Motivational Theories 26

2.3 Theories on Social Processes 27

2.3.1 Social Learning Theory 27

2.3.2 Theories on Communication 27

2.3.3 Social Network Theories 28

2.3.4 Theories on Teamwork 29

2.3.5 Theories on Professionalization 29

2.3.6 Theories on Leadership 30

2.4 Theories on Organizational Systems 31

2.4.1 Theories of Effective Organizations 31

2.4.2 Theory of Quality and Safety Management 31

2.4.3 Theory of Operations Management 33

2.4.4 Theory of Complex Systems 33

2.4.5 Theory of Organizational Learning 34

2.4.6 Theories of Organizational Culture 35

2.5 Theories on Economic and Societal Structures 36

2.5.1 Economic Theories 36

2.5.2 Theories on Contracting 37

2.6 Conclusions 37

References 39

3 Effective Implementation of Change in Healthcare: A Systematic Approach 45
Richard Grol and Michel Wensing

3.1 Elements of Effective Implementation 45

3.2 The Implementation of Change Model 52

3.3 Developing a Proposal and Targets for Change 53

3.4 Assessment of Performance 55

3.5 Analysis of the Target Group and Setting 56

3.5.1 Aims and Settings of the Implementation 57

3.5.2 Segments within the Target Group and Stages of Change 57

3.5.3 Phases in a Process of Change: A Summary of the Literature 58

3.5.4 Orientation 59

3.5.5 Insight 59

3.5.6 Acceptance 59

3.5.7 Change 60

3.5.8 Maintenance 60

3.5.9 Barriers and Facilitators to Changing Practice 60

3.6 Selection and Development of Improvement Strategies 61

3.7 Development, Testing, and Execution of an Implementation Plan 61

3.8 Sustainable Change: Integration of Change into Practice Routines 63

3.9 Evaluation and (Possible) Adaptations to the Plan 63

3.10 Planning of the Implementation Process 66

3.11 Conclusions 68

References 68

4 Planning and Organizing the Change Process 73
Richard Grol and Michel Wensing

4.1 Introduction 73

4.2 A Motivated Team Comprising All Relevant Expertise 75

4.3 Creating a Context for Change 76

4.3.1 The Central Role of Physicians 76

4.3.2 Collaboration in Teams for Patient Care 78

4.4 Involving the Target Group and Stakeholders in the Plan 81

4.5 Leaders and Key Figures 81

4.5.1 Medical Leadership 82

4.6 Project Management: Time Schedule and Responsibilities 82

4.7 Resources and Support 83

4.8 Conclusions 84

References 84

Part II Guidelines and Innovations 87

5 Characteristics of Successful Innovations 89
Richard Grol and Michel Wensing

5.1 Introduction 89

5.2 Various Types of Improvements Require Various Types of Change Proposals 91

5.2.1 Scientific Literature, Guidelines, Decision Support, and Decision Aids 91

5.2.2 Clinical Pathways 92

5.2.3 Improved Care Processes 93

5.2.4 Other Innovations 93

5.3 Characteristics of Innovations That Promote Implementation 94

5.4 Format and Presentation 97

5.5 Involvement of the Target Group and Local Adaptation 99

5.6 Conclusions 100

References 100

6 Clinical Practice Guidelines as a Tool for Improving Patient Care 103
Jako Burgers, Trudy van der Weijden, and Richard Grol

6.1 Introduction 103

6.2 Aims of Guidelines 104

6.3 Potential Benefits and Limitations of Guidelines 105

6.3.1 Potential Benefits 106

6.3.2 Possible Limitations 106

6.4 Development of Effective Guidelines 107

6.4.1 Topic Selection 107

6.4.2 Composition of the Guideline Development Group 110

6.4.3 Patient and Public Involvement 111

6.4.4 Drafting the Scope 113

6.4.5 Development of Draft Guideline 114

6.4.6 Identifying and Reviewing Available Guidelines and Reviews 114

6.4.7 Collection and Evaluation of Scientific Evidence 115

6.4.8 Contribution of All Relevant Expertise and Experience 116

6.4.9 Formulation of Recommendations 116

6.4.10 Consultation and Authorization 118

6.4.11 Consultation 118

6.4.12 Pilot Testing 119

6.4.13 Authorization 119

6.4.14 Design of the Guideline and Related Products 119

6.4.15 Evaluation 120

6.4.16 Updating Guidelines 121

6.5 Quality of Guidelines and Guideline Development Programs 121

6.6 International Collaboration in Guideline Development 123

6.7 Conclusion 124

References 125

Part III Assessment of Performance 131

7 Indicators for Quality and Safety of Care 133
Jozé Braspenning, Rosella Hermens, Hilly Calsbeek, Stephen Campbell, Philip van der Wees, and Richard Grol

7.1 Introduction 133

7.1.1 Aim of the Assessment 135

7.2 Indicators for Quality and Safety of Care 137

7.2.1 Aims of Measurement 137

7.2.2 Domains and Perspectives 138

7.2.3 Categories of Indicators 138

7.3 Methods to Develop a Set of Indicators 140

7.4 Selecting or Developing a Preliminary Set of Indicators 140

7.4.1 Indicator Attributes 141

7.4.2 Number of Indicators 141

7.5 Finding Consensus among Target Users 141

7.5.1 Delphi Technique 142

7.5.2 RAND/UCLA Appropriateness Method 142

7.6 Testing the Indicators Empirically 144

7.6.1 Validity and Reliability 144

7.7 Create a Feedback Report 147

7.7.1 Calculating Indicators and Benchmarks 147

7.7.2 Formulating Aims of Improvement 147

7.8 Use and Effect of Quality Indicators 148

7.8.1 Unintended Effects 148

7.9 Conclusion 149

References 150

Part IV Problem Analysis 155

8 Determinants of Implementation 157
Michel Wensing and Richard Grol

8.1 Introduction 157

8.2 Analysis of Stakeholders 159

8.3 Determinants of Change 161

8.3.1 Individual Health Professional Factors 161

8.3.1.1 Cognitive Factors 161

8.3.1.2 Motivational Factors 162

8.3.1.3 Behavioral Factors (Routines) 163

8.3.2 Patient Factors 163

8.3.3 Professional Interactions 163

8.3.3.1 Team Processes 163

8.3.4 Professional Networks 164

8.3.5 Organizational Factors 165

8.3.5.1 Capacity for Organizational Change 165

8.3.6 Organizational Structure 165

8.3.7 Organizational Culture 166

8.3.8 Availability of Necessary Resources 166

8.3.9 Societal Factors 166

8.3.9.1 Health Professions 166

8.3.9.2 Financial Incentives and Disincentives 167

8.3.9.3 Legislation 167

8.4 Subgroups in the Target Population 167

8.5 Conclusions 168

References 168

9 Methods to Identify and Analyze Determinants of Implementation 173
Michel Wensing and Richard Grol

9.1 Introduction 173

9.2 Interviews 175

9.2.1 Individual Interviews 175

9.2.2 Group Interviews 175

9.3 Surveys 177

9.3.1 Questionnaires about Clinical Guidelines 178

9.3.2 Questionnaires on Theory-Based Determinants of Implementation 178

9.4 Observation 180

9.4.1 Routinely Collected Data 180

9.4.2 Direct Observation 180

9.5 Data Analysis 181

9.5.1 Scientific Methods of Data Analysis 182

9.5.2 Quality Improvement Methods 183

9.5.3 Paretogram 183

9.5.4 Fishbone Diagram 184

9.5.5 Flow Chart 185

9.6 Prioritization and Goal Setting 186

9.7 Conclusions 186

References 187

Part V Strategies for Change 189

10 Selection of Strategies for Improving Patient Care 191
Richard Grol and Michel Wensing

10.1 Introduction 191

10.2 Methods to Select and Develop Implementation Strategies 192

10.2.1 Explorative Methods 194

10.2.2 Theory-Based Methods 196

10.3 Classification of Implementation Strategies 196

10.4 Implementation Strategies in the Different Phases of Change 199

10.4.1 Orientation 200

10.4.2 Insight and Understanding 200

10.4.3 Acceptance 201

10.4.4 Change 201

10.4.5 Maintenance 202

10.5 Subgroups within the Target Group 202

10.6 The Effectiveness of Different Strategies and Interventions 203

10.7 Conclusions 204

References 205

11 Dissemination of Innovations 207
Richard Grol and Michel Wensing

11.1 Introduction 207

11.2 Mass Media Approach 210

11.2.1 Written Materials 210

11.2.2 Internet-Based Approaches 210

11.2.3 Factors Associated with the Impact of Mass Media Strategies 212

11.3 Personalized Approaches 213

11.3.1 CME Courses and Conferences 214

11.3.2 Social Networks 214

11.3.3 Influential Individuals 215

11.3.4 Personal Introduction in Practice 216

11.4 Conclusion 217

References 218

12 Educational Implementation Strategies 221
Michel Wensing, Cornelia Fluit, Jeremy Grimshaw, and Richard Grol

12.1 Introduction 221

12.2 Types of Educational Strategies 223

12.3 Effectiveness of Education 224

12.3.1 Educational Materials 225

12.3.2 Educational Meetings 225

12.3.3 Outreach Visits 226

12.3.4 E-learning 226

12.4 Determinants of the Effectiveness of Education 227

12.4.1 Targets for Education 228

12.4.2 Active Participation 229

12.4.3 Duration of Education 229

12.4.4 Opinion Leaders 229

12.4.5 Assessment and Feedback 230

12.5 Discussion and Conclusions 230

References 231

13 Clinical Performance Feedback and Decision Support 235
Noah Ivers, Benjamin Brown, and Jeremy Grimshaw

13.1 Introduction 235

13.2 Definitions, Characteristics, and Components 238

13.2.1 Feedback 238

13.2.2 Decision Support 238

13.3 Effectiveness of Feedback and Decision Support 239

13.4 Factors Associated with Effects 241

13.4.1 Underlying Assumptions, Relevant Theories, and Mechanisms 241

13.4.2 Factors Associated with Effects 242

13.5 Discussion and Conclusions 246

References 248

14 Engaging Patients in Healthcare Improvement and Innovation 253
Glyn Elwyn and Amy Price

14.1 Introduction 253

14.2 Impact of Patient Engagement on Direct Care 254

14.2.1 Well-Established Conceptual Frameworks 254

14.2.2 Persistent Theory–Practice Gap 255

14.2.3 Broader Impacts 256

14.3 Impact of Patient Engagement on Organizational Design and Governance 257

14.4 Impact of Patient Engagement in Policy Making 259

14.5 Conclusion 260

References 260

15 Organizational Implementation Strategies 263
Michel Wensing, Miranda Laurant, and Richard Grol

15.1 Introduction 263

15.2 Revision of Professional Roles 264

15.3 Enhanced Patient Care Teams 266

15.4 Knowledge Management (Use of IT) 267

15.5 Integrated Care Systems 269

15.6 Quality and Safety Management 271

15.7 Conclusions 272

References 272

16 Patient Safety Strategies 275
Marieke Zegers, Mirelle Hanskamp-Sebregts, Hub Wollersheim, and Charles Vincent

16.1 Introduction 275

16.2 Definition of Patient Safety Concepts 276

16.3 Strategies to Measure Patient Safety 277

16.4 Patient Safety Improvement Strategies 280

16.4.1 Teamwork Training 280

16.4.2 Improved Handovers 280

16.4.3 Rapid Response Team 285

16.4.4 Infection Prevention 285

16.4.5 Delirium Prevention 286

16.4.6 Fall Prevention 287

16.4.7 Pressure Ulcers 287

16.4.8 Pain Management 287

16.4.9 Interventions to Prevent Adverse Drug Events 288

16.5 Strategies to Assure Patient Safety 289

16.5.1 Leadership 289

16.5.2 Safety Culture 290

16.5.3 Governance 290

16.6 Conclusions 292

References 292

17 Health System Strategies for Implementation 299
Michel Wensing, Holger Pfaff, and Richard Grol

17.1 Introduction 299

17.2 Strategies to Enhance Evidence-Based Policy Making 300

17.3 Scaling Up Interventions and Practices 303

17.4 Changes in the Financial Reimbursement of Healthcare Providers 304

17.5 Changes in the Financial Risk for Patients 306

17.6 Changes in the Healthcare System 307

17.7 Conclusions 309

References 309

18 Multifaceted Implementation Strategies 313
Marlies Hulscher and Michel Wensing

18.1 Introduction 313

18.2 Strategies in Multifaceted Implementation Strategies 314

18.3 Effectiveness of Multifaceted Implementation Strategies 320

18.4 Tailoring in Multifaceted Strategies 320

18.5 Volume and Classification of Strategies 321

18.6 Combinations of Specific Strategies 322

18.7 Conclusions 324

References 325

Part VI Organization and Evaluation 329

19 Planning of Implementation 331
Richard Grol

19.1 Introduction 331

19.1.1 Planning of the Implementation Process 334

19.2 Development of the Plan According to Phases in the Change Process 334

19.3 Planning of Activities for Different Levels of Care 336

19.4 Planning of Activities over Time 337

19.5 Incorporating the Implementation Plan into Existing Activities 337

19.6 Testing of the Implementation Strategies 338

19.7 Setting Goals for Evaluation 339

19.8 Integration and Embedding of New Practice into Routines and Organization 340

19.9 Conclusions 342

References 343

20 Experimental Designs for Evaluation of Implementation Strategies 345
Michel Wensing and Jeremy Grimshaw

20.1 Introduction 345

20.2 Experimental Study Designs 347

20.2.1 Pragmatic versus Explanatory Trials 348

20.2.2 Cluster Randomization 348

20.2.3 Options for Choice of Study Groups 349

20.2.4 Block Designs 349

20.2.5 Allocation of Participants to Study Arms 350

20.3 Outcome Measures and Data-Collection Methods 351

20.4 Statistical Power and Data Analysis 353

20.5 Regulatory and Ethical Considerations 354

20.6 Conclusion 354

References 355

21 Observational Evaluation of Implementation Strategies 357
Michel Wensing and Jeremy Grimshaw

21.1 Introduction 357

21.2 Designs for Observational Evaluations 358

21.3 Cross-Sectional Studies 359

21.4 Before–After Comparisons 359

21.5 Controlled Before–After Comparisons 361

21.6 Multiple Case Studies 363

21.7 Developmental Research 364

21.8 Data Analysis in Observational Evaluation Designs 365

21.9 Conclusions 366

References 366

22 Process Evaluation of Implementation Strategies 369
Marlies Hulscher and Michel Wensing

22.1 Introduction 369

22.2 Frameworks for Process Evaluation 370

22.3 Process Evaluation and Implementation Strategies 372

22.3.1 Evaluation of Pilots and Small Improvement Projects 373

22.3.2 Evaluation of Strategies in Experimental Designs 373

22.3.3 Evaluation of Improvement Programs in Observational Designs 374

22.4 Assessing the Fidelity of Implementation Strategies 374

22.5 Framing Process Evaluations 378

22.6 A Practical, Step-wise Approach to Process Evaluation 381

22.6.1 Step 1: Analysis of Implementation Strategy as Planned 381

22.6.2 Step 2: Assessment of Intervention Fidelity 382

22.6.3 Step 3: Assessment of Participant Experiences 383

22.6.4 Step 4: Exploration of Working Mechanisms 384

22.7 Conclusions 385

References 386

23 Economic Evaluation of Implementation Strategies 389
Johan L. Severens, Ties Hoomans, Eddy Adang, and Michel Wensing

23.1 Introduction 389

23.2 The Basics of Economic Evaluation 390

23.2.1 Definition of Cost-Effectiveness 391

23.3 Types of Economic Evaluation 392

23.4 Policy Cost-Effectiveness 395

23.5 Framing Economic Evaluations 396

23.5.1 Choice of Comparator 396

23.5.2 Time Horizon of a Study 396

23.5.3 Study Perspective 396

23.6 Cost Analysis 398

23.6.1 Directly Attributable, Indirectly Attributable, Fixed, and Variable Costs 398

23.6.2 Categories of Costs 399

23.6.3 Volumes and Cost Prices 400

23.7 Sensitivity Analysis, Quantitative Modeling, and Budget Impact 402

23.7.1 Sensitivity Analysis 402

23.7.2 Quantitative Modeling 403

23.7.3 Budget Impact Analysis 404

23.8 Ex Post Evaluation of the Efficiency of Implementation 405

23.9 Conclusions 405

References 406

Index 409