Funding National Institute of Diabetes and Digestive and Kidney Diseases of NIH (R34DK084009). Funding source had no role in the design, execution, analyses,

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Funding National Institute of Diabetes and Digestive and Kidney Diseases of NIH (R34DK084009). Funding source had no role in the design, execution, analyses, or interpretation of the data. Disclosure Authors of this presentation have no disclosures concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation. Acknowledgements Mayo Clinic: Sara Heim, Vicki Clark, Kasey Boehmer, Marc Matthews MD, Gregory Bartel MD, Jennifer Pecina MD, Laura Pelaez MD Olmsted Medical Center: Alice Medlyn RN, Linda Paradise RN, Randy Hemann MD, Daniel Swartz MD, Linda Williams MD, Craig Thauwald MD, Daniel Pesch MD, Shaun Dekutoski MD, Dale Loeffler DO Decision Aids to Enhance Shared Decision Making in Diabetes: A Randomized Trial Holly Van Houten 1, Megan Branda MS 1, Nilay Shah PhD 1, Barbara Yawn MD 2, Annie LeBlanc PhD 3, Laurie Pencille 3, Kari Ruud MEd 3, Marge Kurland 2, Victor Montori MD 3 1 Division of Health Care Policy & Research, Mayo Clinic; 2 Olmsted Medical Center, 3 Knowledge and Evaluation Research Unit, Mayo Clinic PURPOSE To obtain estimates of the impact of patient decision aids versus usual care on measures of patient involvement in decision- making and diabetes control METHODS Study Design Practice-level, multi-site cluster randomized trial Patient decision aids versus usual care Randomized 10 participating primary care practices to implement either: Diabetes Medication Choice Statin Choice Study Population Patients with diabetes were enrolled between March 2010 and July 2011 in rural primary care practices Eligibility criteria: Age 18+ years Type 2 diabetes Maximum dosages of current medications Planning to discuss changing/adding medication HbA1c > 7.3 for diabetes discussion only Data Collection Abstraction from the medical & pharmacy records Surveys administered to patients and clinicians Demographics *no significant differences between study arms RESULTS *modified and adjusted by discussion and study arm LIMITATIONS This was a feasibility study Too small and brief to conclude about the effectiveness of decision aids in diabetes Efficacy and feasibility of decision aids confirmed with suggestive results of improved medication adherence Several lessons to improve the feasibility of larger study were drawn For more information Overall (n=103) Decision Aid (n=53) Usual Care (n=50) Discussion to start medication Diabetes39 (37.9%)27 (50.9%)12 (24.0%) Statin64 (62.1%)26 (49.1%)38 (76.0%) Male63 (61.2%)37 (69.8%)26 (52.0%) Age (years)57.6 ± ± ± 11.4 DM duration 5+ yrs50 (48.5%)29 (54.7%)21 (42.0%) CONCLUSIONS We were able to deliver decision aids to intervention patients in nonurban clinics, but the trial had important feasibility challenges Decision aids more likely to spark conversation about medications inform patients about options, risks and benefits of each medication Clinicians felt decision aid was easy to deliver during patient office visit for support staff to integrate in daily activities Pharmacy DA patients were more adherent and persistent IMPLICATIONS FOR PRACTICE OR POLICY Tough to implement shared decision making in a pragmatic trial when quality metrics are disease centric, patients do not expect involvement, and clinicians are not trained to share decisions. Both trials and decision aids must be designed to fit the characteristics of users and practices. Much more work is needed in this area. Decision AidUsual CareP-Value Patient post-visit survey n=52 n=47 Discussion to start medication40 (76.9%)21 (44.7%)< Diabetes Knowledge questions3.1 (1.0)1.8 (0.8) Decisional Conflict Subscale: information* 80.8 (1.8)75.8 (1.5)< Clinician post-visit survey n=49 n=47 Discussion to start medication44 (89.9%)32 (68.1%) Felt delivery of DA was very easy/easy 35 (81.4%)-- Felt support staff integration of DA was very easy/easy 35 (81.4%)-- Pharmacy Data n=43 n=44 Adherence > 80%25 (58.1)%20 (45.4%) Persistence (days)189.8 (48.1)97.6 (37.4)0.0062