Abstract
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
Highlights
Shared decision making contributes to high quality healthcare by promoting a patient-centered approach
In close collaboration with a multidisciplinary team of patients, clinicians, and designers, we have developed decision aids targeting glycemic and cardiovascular risk factor control through medication therapy (Diabetes Medication Choice, Statin Choice) [6,7]
There is urgent need to conduct patientcentered translational practice-based research in diabetes care. To pursue this effort we propose to 1) evaluate, in a cluster-randomized practical trial enrolling primary care practices and their patients with type 2 diabetes, 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; and 2) identify, describe, and explain, using a theory-driven qualitative research approach, factors that promote or inhibit the routine embedding of decision aids in the rural and suburban practices participating in the randomized trial
Summary
The proposed trial seeks to determine 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 urban and rural practices in the Midwestern United States. The Knowledge and Evaluation Research Unit at Mayo Clinic houses the processes of design and evaluation of decision aids, such as Diabetes Medication Choice and Statin Choice, decides on topics of investigation, pursues funding, designs and conducts evaluation trials, and reports their findings. Author details 1Department of Health Sciences Research, Division of Health Care Policy and Research, Mayo Clinic, Rochester, MN, USA. Author details 1Department of Health Sciences Research, Division of Health Care Policy and Research, Mayo Clinic, Rochester, MN, USA. 2Knowledge and Evaluation Research Unit, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA. 3Center for the Science of Healthcare Delivery, Mayo Clinic, Rochester, MN, USA. 4Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA. 5Department of Anthropology and Sociology, Université Lumière Lyon 2, Lyon, France. 6Department of Research, Olmsted Medical Center, Rochester, MN, USA. 7Department of Family and Community Health, University of Minnesota, Minneapolis, MN, USA. 8Family Medicine, Mayo Clinic, Rochester, MN, USA. 9Faculty of Health Sciences, University of Southampton, Southampton, UK. 10Department of Medicine, Division of Endocrinology, Mayo Clinic, Rochester, MN, USA
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