Protocol for a hybrid type 1 effectiveness-implementation trial of a mind-body activity program for older adults with chronic pain in a medically underserved area: The iHOPE study.

BACKGROUND: Older adults in medically underserved areas (MUAs) are disproportionately affected by chronic musculoskeletal pain but lack access to safe, evidence-based psychosocial treatments. Staff at community clinics, where many disadvantaged older adults receive care, must manage complex pain needs and comorbidities with limited time and resources. Shared medical visits integrate medical care, education, and peer support, offering a feasible, scalable solution to overcome barriers associated with chronic pain management in primary care. We previously developed GetActive+, an intervention delivered through shared medical visits at a community clinic to teach mind-body and activity skills to older adults with chronic pain. Here, we describe the protocol for a fully powered hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) comparing GetActive+ to treatment as usual (TAU). METHODS: We will recruit 200 English and Spanish-speaking older adult patients from two Massachusetts community clinics located in an MUA. We will assess multimodal physical function and psychosocial outcomes at baseline, post-intervention (11 weeks), and follow-up (6 months). Effectiveness will be determined by improvements in self-reported physical function post-intervention compared to TAU. Using mixed methods, we will assess implementation outcomes (feasibility, acceptability, fidelity, and adoption) at patient, provider, and organizational levels. RESULTS: The trial is ongoing. We have enrolled 54 older adults, 21 of whom have completed post-intervention assessments. CONCLUSION: We describe the implementation and evaluation of a mind-body activity intervention for older adults with chronic pain using shared medical visits. Results will inform subsequent implementation and dissemination efforts of GetActive+ in community clinics across the United States. CLINICAL TRIALS REGISTRATION NUMBER: NCT06119698.