The impact of decision aids to enhance shared decision making for diabetes (the DAD study): protocol of a cluster randomized trial

BackgroundShared decision making contributes to high quality healthcare by promoting a patient-centered approach. Patient involvement in selecting the components of a diabetes medication program that best match the patient’s values and preferences may also enhance medication adherence and improve outcomes. Decision aids are tools designed to involve patients in shared decision making, but their adoption in practice has been limited. In this study, we propose to obtain a preliminary estimate of the impact of patient decision aids vs. usual care on measures of patient involvement in decision making, diabetes care processes, medication adherence, glycemic and cardiovascular risk factor control, and resource utilization. In addition, we propose to identify, describe, and explain factors that promote or inhibit the routine embedding of decision aids in practice.Methods/DesignWe will be conducting a mixed-methods study comprised of a cluster-randomized, practical, multicentered trial enrolling clinicians and their patients (n = 240) with type 2 diabetes from rural and suburban primary care practices (n = 8), with an embedded qualitative study to examine factors that influence the incorporation of decision aids into routine practice. The intervention will consist of the use of a decision aid (Statin Choice and Aspirin Choice, or Diabetes Medication Choice) during the clinical encounter. The qualitative study will include analysis of video recordings of clinical encounters and in-depth, semi-structured interviews with participating patients, clinicians, and clinic support staff, in both trial arms.DiscussionUpon completion of this trial, we will have new knowledge about the effectiveness of diabetes decision aids in these practices. We will also better understand the factors that promote or inhibit the successful implementation and normalization of medication choice decision aids in the care of chronic patients in primary care practices.Trial registrationNCT00388050

[1]  Roger. T. Anderson,et al.  Health-related quality of life and cost-effectiveness components of the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial: rationale and design. , 2007, The American journal of cardiology.

[2]  Anselm L. Strauss,et al.  Qualitative Analysis For Social Scientists , 1987 .

[3]  L. Davies ECONOMIC EVALUATION IN CLINICAL TRIALS , 1998 .

[4]  F. Légaré,et al.  Barriers and facilitators to implementing shared decision-making in clinical practice: a systematic review of health professionals' perceptions , 2006, Implementation science : IS.

[5]  Matthew B. Miles,et al.  Qualitative Data Analysis: An Expanded Sourcebook , 1994 .

[6]  G. Elwyn,et al.  The OPTION scale: measuring the extent that clinicians involve patients in decision‐making tasks , 2005, Health expectations : an international journal of public participation in health care and health policy.

[7]  Allan Donner,et al.  Design and Analysis of Cluster Randomization Trials in Health Research , 2001 .

[8]  R. Glasgow RE-AIMing research for application: ways to improve evidence for family medicine. , 2006, Journal of the American Board of Family Medicine : JABFM.

[9]  Maggie Breslin,et al.  Creating a Conversation: Insights from the Development of a Decision Aid , 2007, PLoS medicine.

[10]  Timothy P. Hofer,et al.  When do patients and their physicians agree on diabetes treatment goals and strategies, and what difference does it make? , 2003, Journal of General Internal Medicine.

[11]  R. Glasgow,et al.  The RE-AIM framework for evaluating interventions: what can it tell us about approaches to chronic illness management? , 2001, Patient education and counseling.

[12]  David O. Meltzer,et al.  Patient Perceptions of Quality of Life With Diabetes-Related Complications and Treatments , 2007 .

[13]  C. Dowrick,et al.  Implementation Science Development of a Theory of Implementation and Integration: Normalization Process Theory , 2022 .

[14]  Gordon H Guyatt,et al.  The diabetes mellitus medication choice decision aid: a randomized trial. , 2009, Archives of internal medicine.

[15]  G. Elwyn,et al.  Shared decision making: developing the OPTION scale for measuring patient involvement , 2003, Quality & safety in health care.

[16]  Maggie Breslin,et al.  The design of a decision aid about diabetes medications for use during the consultation with patients with type 2 diabetes. , 2008, Patient education and counseling.

[17]  S. Michie Talking to primary care patients about weight: A study of GPs and practice nurses in the UK , 2007, Psychology, health & medicine.

[18]  H. Hearnshaw,et al.  What do we mean by adherence to treatment and advice for living with diabetes? A review of the literature on definitions and measurements , 2006, Diabetic medicine : a journal of the British Diabetic Association.

[19]  N. Denzin,et al.  The Sage Handbook of Qualitative Research , 2007 .

[20]  Rebecca L. Kesman,et al.  Use of a decision aid to improve treatment decisions in osteoporosis: the osteoporosis choice randomized trial. , 2011, The American journal of medicine.

[21]  Benjamin Eng,et al.  The potential effects of HEDIS performance measures on the quality of care. , 2008, Health affairs.

[22]  Amiram Gafni,et al.  Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. , 2007, Archives of internal medicine.

[23]  A. O'Connor Validation of a Decisional Conflict Scale , 1995, Medical decision making : an international journal of the Society for Medical Decision Making.

[24]  N. Denzin,et al.  The Sage handbook of qualitative research, 3rd ed. , 2005 .

[25]  Shari Bolen,et al.  Systematic Review: Comparative Effectiveness and Safety of Oral Medications for Type 2 Diabetes Mellitus , 2007, Annals of Internal Medicine.

[26]  P. Yudkin,et al.  Putting theory into practice: a cluster randomized trial with a small number of clusters. , 2001, Statistics in medicine.

[27]  J. Ware,et al.  Measuring Health Perceptions in the Health Insurance Experiment , 1981 .

[28]  Amiram Gafni,et al.  Clinician's use of the Statin Choice decision aid in patients with diabetes: a videographic study nested in a randomized trial. , 2009, Journal of evaluation in clinical practice.

[29]  L. Pogach,et al.  Diabetes process and outcome measures in the Department of Veterans Affairs. , 2004, Diabetes care.

[30]  E. Vermeire,et al.  Interventions for improving adherence to treatment recommendations in people with type 2 diabetes mellitus. , 2005, The Cochrane database of systematic reviews.

[31]  P. Dolan,et al.  Health state valuations from the general public using the Visual Analogue Scale , 1996, Quality of Life Research.