Clinical Trial

The Healing and Empowerment Actions for Recovery From Trauma (HEART) Trial

Study acronym: HEART
Not Yet Recruiting
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Summary
The HEART Trial aimed to determine if wrap-around psychosocial support for patients who sustain moderate to severe trauma requiring orthopedic surgery intervention improves outcomes for patients (Aim 1), care-partners (Aim 2), and healthcare workers (Aim 3) as well as explore implementation strategies to improve health systems' capabilities and capacity to integrate psychosocial support services. The comparators represent real healthcare options for patients, caregivers, and healthcare workers. The HEART Trial is a multicenter pragmatic, stepped-wedge cluster randomized, hybrid type I comparative effectiveness-implementation superiority trial. The study intervention (C-TRP) is a trauma-focused psychosocial intervention, with each site serving as its own control (TRP).
Trial Details
NCT Number NCT07584252
Lead Sponsor Stephanie Di Stasi
Collaborators: Patient-Centered Outcomes Research Institute
Conditions Trauma Blunt, Orthopedic
Enrollment 804 participants
Start Date 2026-07-01
Primary Completion 2030-08-01 (estimated)
Study Completion 2032-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-13