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The authors of this protocol disclose no financial conflict of interest pertinent to this study. 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. Investigators at the KER unit, including authors of this manuscript, do not receive funding from any for-profit pharmaceutical or device manufacturer, nor do they receive any royalties or other monetary benefits, directly or indirectly, from the use of the decision aids. The KER unit makes effective decision aids available online free of charge at http://kerunit.e-bm.org, http://kercards.e-bm.info/ and http://shareddecisions.mayoclinic.org/.
AL wrote the first draft of the manuscript. KLR contributed to the first draft of the manuscript and made critical revisions to the manuscript. NDS, BPY, CRM and VMM conceived and designed the study, applied for funding, and made critical revisions to the manuscript. MEB, KT, LJP, and HVH contributed to the design of the study and provided revisions of the manuscript. KRB and MM made critical revisions to the manuscript. All authors approved the final version of this manuscript.
Shared 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.
We 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.
Upon 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.