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

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

Journal: Endocrine 2022;75(2):377-391

PMID: 34499328

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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.

Address: Knowledge and Evaluation Research Unit, Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USA.; Medical Decision Making, Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.; Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado-Denver Anschutz Medical Campus, Aurora, CO, USA.; Division of Biomedical Statistics and Informatics, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.; Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.; Laboratoire d'anthropologie des enjeux contemporains, Lyon, France.; Faculty of Public Health and Policy, London School of Hygiene and Tropical Medicine, London, UK.; Department of Medicine, Hennepin Healthcare and University of Minnesota, Minneapolis, MN, USA.; Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Rochester, MN, USA.; Department of Psychiatry and Psychology, Mayo Clinic Health System, Mankato, MN, USA.; Department of Family Medicine and Community Health, University of Minnesota Medical School, Minneapolis, MN, USA.; Practice-Based Research Network, Mayo Clinic, Rochester, MN, US.; Center for Translational Science Activities, Mayo Clinic, Rochester, MN, USA.; Center for Patient and Provider Experience, Hennepin County Medical Center, Minneapolis, MN, USA.; School of Nursing, University of Minnesota, Minneapolis, MN, USA.; Decision Partners for Health, Richfield, MN, USA.; Mayo Clinic Health System Northwest Wisconsin, (dept) Home Health and Hospice, Eau Claire, WI, USA.; Department of Family and Emergency Medicine, Faculty of Medicine, Laval University, Quebec, QC, Canada.; Park Nicollet International Diabetes Center, St. Louis Park, MN, USA.; Mayo Clinic Health System, La Crosse, WI, US.; Kern Center for the Science of Health Care Deliver, Mayo Clinic, Rochester, MN, USA.; Office of Professional Worklife, Hennepin Healthcare, Minneapolis, MN, USA.; Department of Internal Medicine, Park Nicollet Clinic, Brooklyn Center, MN, USA.; Division of Epidemiology, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.; Division of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.; Center for Evaluation and Survey Research, HealthPartners Institute, Bloomington, USA.; Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, MN, USA.; Division of Health Care Policy and Research, Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA. [email protected].; Mayo Clinic Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Rochester, MN, USA. [email protected].

DOI: 10.1007/s12020-021-02861-4

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MeSH Terms: Decision Making, Decision Support Techniques, Diabetes Mellitus, Type 2, Humans, Medication Adherence, Patient Participation