ORIGINAL RESEARCH
Deborah J. Cohen, PhD; Shannon M. Sweeney, MPH, PhD; Rachel Springer, MS; Bijal A. Balasubramanian, MBBS, PhD; LeAnn Michaels; Miguel Marino, PhD; Danielle Hessler, PhD; Andrea Baron, MPH; Johanna Nesse, FNP
Corresponding Author: Deborah Cohen, PhD; Department of Family Medicine, Oregon Health & Science University
Email: cohendj@ohsu.edu
DOI: 10.3122/jabfm.2024.240265R1
Keywords: Behavioral Counseling, Chronic Care Management, Diabetes, Disease Management, Integrated Health Care Systems, Outcome Measures, Patient Health Questionnaire, Primary Health Care, Psychosocial Care, Type 2 Diabetes Mellitus
Dates: Submitted: 07-15-2024; Revised: 10-22-2024; Accepted: 11-04-2024
Status: In production for ahead of print.
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 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 (e.g., 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 (e.g., remote facilitation and training sessions). Despite an adapted delivery and COVID 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.