TY - JOUR AU - B. M. Kwan AU - L. M. Dickinson AU - J. Dailey-Vail AU - R. E. Glasgow AU - R. M. Gritz AU - D. Gurfinkel AU - C. M. Hester AU - J. S. Holtrop AU - P. Hosokawa AU - A. Lanigan AU - D. E. Nease Jr. AU - A. Nederveld AU - P. Phimphasone-Brady AU - N. D. Ritchie AU - M. Sajatovic AU - R. Wearner AU - A. Begum AU - M. Carter AU - T. Carrigan AU - B. Clay AU - D. Downey AU - R. Koren AU - S. A. Trujillo AU - J. A. Waxmonsky A1 - AB - BACKGROUND: Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known. OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes. DESIGN: Pragmatic cluster randomized trial. PARTICIPANTS: A total of 1060 adults with type 2 diabetes in 22 primary care practices. INTERVENTIONS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors). MAIN MEASURES: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models. KEY RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions. CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order. NIH TRIAL REGISTRY NUMBER: NCT03590041. AD - Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, USA. bethany.kwan@cuanschutz.edu.; Adult & Child Center for Outcomes Research & Delivery Science, University of Colorado Anschutz Medical Campus, Aurora, CO, USA. bethany.kwan@cuanschutz.edu.; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA. bethany.kwan@cuanschutz.edu.; Department of Family Medicine, University of Colorado School of Medicine, Aurora, CO, USA.; Adult & Child Center for Outcomes Research & Delivery Science, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.; University of Colorado College of Nursing, Aurora, CO, USA.; Division of Health Care Policy & Research, University of Colorado School of Medicine, Aurora, CO, USA.; American Academy of Family Physicians National Research Network, Leawood, KS, USA.; Office of Research, Denver Health & Hospital Authority, Denver, CO, USA.; Department of Psychiatry, University of Colorado School of Medicine, Aurora, CO, USA.; Departments of Psychiatry and Neurology, University Hospitals Cleveland Medical Center, Case Western Reserve University School of Medicine, Cleveland, OH, USA.; Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.; Invested in Diabetes Patient Partners, Aurora, CO, USA. AN - 38943014 BT - J Gen Intern Med C5 - Education & Workforce CP - 15 DA - Nov DO - 10.1007/s11606-024-08868-7 DP - NLM ET - 20240628 IS - 15 JF - J Gen Intern Med LA - eng N2 - BACKGROUND: Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known. OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes. DESIGN: Pragmatic cluster randomized trial. PARTICIPANTS: A total of 1060 adults with type 2 diabetes in 22 primary care practices. INTERVENTIONS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors). MAIN MEASURES: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models. KEY RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions. CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order. NIH TRIAL REGISTRY NUMBER: NCT03590041. PY - 2024 SN - 0884-8734 (Print); 0884-8734 SP - 2970 EP - 2979+ ST - Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial T1 - Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial T2 - J Gen Intern Med TI - Comparative Effectiveness of Patient-Driven versus Standardized Diabetes Shared Medical Appointments: A Pragmatic Cluster Randomized Trial U1 - Education & Workforce U3 - 10.1007/s11606-024-08868-7 VL - 39 VO - 0884-8734 (Print); 0884-8734 Y1 - 2024 ER -