The Healing and Empowerment Actions for Recovery From Trauma (HEART) Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorStephanie Di Stasi
About this trial
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).
Eligibility criteria
Qualifiers
Age >= 18 years
Anticipated hospital length of stay > 72 hours
Moderate to severe orthopaedic trauma treated surgically for 1 or more injuries
GCS >= 13 at the time of enrollment
Disqualifiers
Non-english speaking (must be sufficiently fluent in English to consent and complete surveys without interpretive services)
Prior to index hospitalization, patient must not be receiving home services or be independent in daily tasks
Any penetrating brain injury
Patients with significant burn injury
Trial design
Treatments tested in this trial
- Comprehensive trauma recovery programming (C-TRP)
- Standard of Care (Investigator Selected)
Treatment groups
804 Participants
are divided into 2 treatment groupsSponsors and collaborators
Stephanie Di Stasi
Lead sponsor
Ohio State University
Sponsor institution
Patient-Centered Outcomes Research Institute
Collaborator
Source ClinicalTrials.gov