Making sense of diabetes medication decisions: a mixed methods cluster randomized trial using a conversation aid intervention

Marleen Kunneman, Megan E Branda, Jennifer L Ridgeway, Kristina Tiedje, Carl R May, Mark Linzer, Jonathan Inselman, Angela L H Buffington, Jordan Coffey, Deborah Boehm, James Deming, Sara Dick, Holly van Houten, Annie LeBlanc, Juliette Liesinger, Janet Lima, Joanne Nordeen, Laurie Pencille, Sara Poplau, Steven Reed, Anna Vannelli, Kathleen J Yost, Jeanette Y Ziegenfuss, Steven A Smith, Victor M Montori, Nilay D Shah, Marleen Kunneman, Megan E Branda, Jennifer L Ridgeway, Kristina Tiedje, Carl R May, Mark Linzer, Jonathan Inselman, Angela L H Buffington, Jordan Coffey, Deborah Boehm, James Deming, Sara Dick, Holly van Houten, Annie LeBlanc, Juliette Liesinger, Janet Lima, Joanne Nordeen, Laurie Pencille, Sara Poplau, Steven Reed, Anna Vannelli, Kathleen J Yost, Jeanette Y Ziegenfuss, Steven A Smith, Victor M Montori, Nilay D Shah

Abstract

Purpose: To determine the effectiveness of a shared decision-making (SDM) tool versus guideline-informed usual care in translating evidence into primary care, and to explore how use of the tool changed patient perspectives about diabetes medication decision making.

Methods: In this mixed methods multicenter cluster randomized trial, we included patients with type 2 diabetes mellitus and their primary care clinicians. We compared usual care with or without a within-encounter SDM conversation aid. We assessed participant-reported decisions made and quality of SDM (knowledge, satisfaction, and decisional conflict), clinical outcomes, adherence, and observer-based patient involvement in decision-making (OPTION12-scale). We used semi-structured interviews with patients to understand their perspectives.

Results: We enrolled 350 patients and 99 clinicians from 20 practices and interviewed 26 patients. Use of the conversation aid increased post-encounter patient knowledge (correct answers, 52% vs. 45%, p = 0.02) and clinician involvement of patients (Mean between-arm difference in OPTION12, 7.3 (95% CI 3, 12); p = 0.003). There were no between-arm differences in treatment choice, patient or clinician satisfaction, encounter length, medication adherence, or glycemic control. Qualitative analyses highlighted differences in how clinicians involved patients in decision making, with intervention patients noting how clinicians guided them through conversations using factors important to them.

Conclusions: Using an SDM conversation aid improved patient knowledge and involvement in SDM without impacting treatment choice, encounter length, medication adherence or improved diabetes control in patients with type 2 diabetes. Future interventions may need to focus specifically on patients with signs of poor treatment fit.

Clinical trial registration: ClinicalTrial.gov: NCT01502891.

Keywords: Decision aids; Diabetes; Patient-centered care; Patient–clinician communication; Shared decision making.

Conflict of interest statement

V.M.M. is lead investigator in the Knowledge and Evaluation Research Unit, a research team that designs, implements, and evaluates SDM tools which, if found useful, are placed in the public domain and produce no income to the unit or its investigators. M.L. is supported for physician burnout prevention studies through Hennepin Healthcare by the American Medical Association, the American College of Physicians, the Institute for Healthcare Improvement, and the American Board of Internal Medicine. He is also supported by NIH and AHRQ, and consults on a grant for Harvard University on diagnostic accuracy and working conditions. He was supported for work on this project by AHRQ. No other competing interests are reported.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
Study flowchart

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Source: PubMed

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