TY - JOUR AU - D. J. Cohen AU - S. M. Sweeney AU - R. Springer AU - B. A. Balasubramanian AU - L. Michaels AU - M. Marino AU - D. Hessler AU - A. Baron AU - J. Nesse A1 - AB - BACKGROUND: This proof-of-concept study tested the feasibility and acceptability of INTEGRATE-D, an implementation support intervention for primary care clinics to improve the psychosocial care of patients with type 2 diabetes. METHODS: Cluster randomized controlled pragmatic trial, with a parallel, convergent mixed methods design. Two Intervention Clinics (ICs) were offered tailored training on American Diabetes Association (ADA)-recommended psychosocial care and facilitation to identify and support clinical change. Two Control Clinics (CCs) received no intervention. PRIMARY OUTCOMES: intervention acceptability, appropriateness and feasibility. SECONDARY OUTCOMES: process-of-care metrics (eg, depression screening, diabetes management) and clinical outcomes measures (PHQ-9 and A1C). Qualitative data were collected to assess implementation and experience with the intervention. RESULTS: ICs were offered training and received 15-months of facilitation. To accommodate COVID-19-related safety restrictions, the intervention was changed to be delivered virtually (eg, remote facilitation and training sessions). Despite an adapted delivery and COVID-19 and staffing stressors, clinics exposed to INTEGRATE-D found it to be acceptable, well-aligned with clinics' needs, and feasible. Qualitative data suggest COVID-19 stressors tempered feasibility. The effect of INTEGRATE-D on process and clinical outcome measures were mixed. Several factors, including differences in ICs and CCs not addressed in randomization and delivery of a less intensive intervention due to the pandemic, may help explain these results. CONCLUSIONS: Given the growing number of people with type 2 diabetes and the importance of psychosocial care for these patients, INTEGRATE-D warrants further pilot-testing with a larger sample of clinics and patients, and under conditions where in-person facilitation and expanded training is possible. AD - From the Department of Family Medicine, Oregon Health & Science University, 3181 Sam Jackson Park Road, Portland, OR (DJC, SMS, RS, LM, MM, AN); Department of Epidemiology, University of Texas Health Science Center at Houston School of Public Health, Dallas, TX (BAB); Department of Family Medicine, University of California, San Francisco, CA (DH); OHSU Primary Care, Beaverton, OR (JN). cohendj@ohsu.edu).; From the Department of Family Medicine, Oregon Health & Science University, 3181 Sam Jackson Park Road, Portland, OR (DJC, SMS, RS, LM, MM, AN); Department of Epidemiology, University of Texas Health Science Center at Houston School of Public Health, Dallas, TX (BAB); Department of Family Medicine, University of California, San Francisco, CA (DH); OHSU Primary Care, Beaverton, OR (JN). AN - 40578908 BT - J Am Board Fam Med C5 - Medically Unexplained Symptoms; Education & Workforce CP - 2 DA - Jun 27 DO - 10.3122/jabfm.2024.240265R1 DP - NLM ET - 20250627 IS - 2 JF - J Am Board Fam Med LA - eng N2 - BACKGROUND: This proof-of-concept study tested the feasibility and acceptability of INTEGRATE-D, an implementation support intervention for primary care clinics to improve the psychosocial care of patients with type 2 diabetes. METHODS: Cluster randomized controlled pragmatic trial, with a parallel, convergent mixed methods design. Two Intervention Clinics (ICs) were offered tailored training on American Diabetes Association (ADA)-recommended psychosocial care and facilitation to identify and support clinical change. Two Control Clinics (CCs) received no intervention. PRIMARY OUTCOMES: intervention acceptability, appropriateness and feasibility. SECONDARY OUTCOMES: process-of-care metrics (eg, depression screening, diabetes management) and clinical outcomes measures (PHQ-9 and A1C). Qualitative data were collected to assess implementation and experience with the intervention. RESULTS: ICs were offered training and received 15-months of facilitation. To accommodate COVID-19-related safety restrictions, the intervention was changed to be delivered virtually (eg, remote facilitation and training sessions). Despite an adapted delivery and COVID-19 and staffing stressors, clinics exposed to INTEGRATE-D found it to be acceptable, well-aligned with clinics' needs, and feasible. Qualitative data suggest COVID-19 stressors tempered feasibility. The effect of INTEGRATE-D on process and clinical outcome measures were mixed. Several factors, including differences in ICs and CCs not addressed in randomization and delivery of a less intensive intervention due to the pandemic, may help explain these results. CONCLUSIONS: Given the growing number of people with type 2 diabetes and the importance of psychosocial care for these patients, INTEGRATE-D warrants further pilot-testing with a larger sample of clinics and patients, and under conditions where in-person facilitation and expanded training is possible. PY - 2025 SN - 1557-2625 SP - 253 EP - 274+ ST - Intervention to Improve Psychosocial Care for People with Type 2 Diabetes T1 - Intervention to Improve Psychosocial Care for People with Type 2 Diabetes T2 - J Am Board Fam Med TI - Intervention to Improve Psychosocial Care for People with Type 2 Diabetes U1 - Medically Unexplained Symptoms; Education & Workforce U3 - 10.3122/jabfm.2024.240265R1 VL - 38 VO - 1557-2625 Y1 - 2025 ER -