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

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.

Trial of a New Diabetes Education Model: Closing the Gap in Health Disparity for People with Diabetes.

BACKGROUND: Quality measures relating to diabetes care in America have not improved between 2005 and 2016, and have plateaued even in areas that outperform national statistics. New approaches to diabetes care and education are needed and are especially important in reaching populations with significant barriers to optimized care. METHODS: A pilot quality improvement study was created to optimize diabetes education in a clinic setting with a patient population with significant healthcare barriers. Certified Diabetes Care and Education Specialists (CDCES) were deployed in a team-based model with flexible scheduling and same-day education visits, outside of the traditional framework of diabetes education, specifically targeting practices with underperforming diabetes quality measures, in a clinic setting significantly impacted by social determinants of health. RESULTS: A team-based and flexible diabetes education model decreased hemoglobin A1C for individuals participating in the project (and having a second A1C measured) by an average of -2.3%, improved Minnesota Diabetes Quality Measures (D5) for clinicians participating in the project by 5.8%, optimized use of CDCES, and reduced a high visit fail rate for diabetes education. CONCLUSIONS: Diabetes education provided in a team-based and flexible model may better meet patient needs and improve diabetes care metrics, in settings with a patient population with significant barriers.