The Healing and Empowerment Actions for Recovery From Trauma (HEART) Trial
Starting soon · Not applicable
Conditions studied: Trauma Blunt, Orthopedic
In brief
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).
Key facts
- Study ID
- NCT07584252
- Run by
- Stephanie Di Stasi
- People needed
- 804
- Starts
- 2026-07-01
- Expected to finish
- 2032-03-01
- Last updated by the study team
- 2026-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Willing and able to meet with Evellere coach while hospitalized or via the telephone within 72 hours of discharge (intervention cohort only)
You may not qualify if…
- 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
- Prior cognitive impairment
- Hospital death or imminent death
- Hospice care at time of trauma or selection for hospice during initial hospital admission or do not resuscitate or comfort care only before index visit
- Prisoner/ inmate or police/ security intervention during hospitalization
- No reliable internet access at baseline
- Psychosis
- Trauma presentation is a result of suicide attempt/ self-harm
- Care Partners
- Inclusion criteria:
- Identified by the enrolled patient as a primary source of support during their recovery. A care partner can be in person or supporting remotely.
- Age >= 18 years
- Willing and able to meet with an Evellere coach during patient hospitalization or via telephone within 72 hours of discharge (intervention cohort only)
- Exclusion criteria:
- Non-english speaking (must be sufficiently fluent in English to consent and complete surveys without interpretive services)
- Paid professionals or home healthcare providers whose support is provided as part of employment (e.g., nurses, aides, case managers)
- Already enrolled as a care partner for another participant in the HEART Trial
- Hospitalized at time of patient enrollment
- No reliable internet access at baseline
- Healthcare Workers
- Inclusion criteria:
- Age > 18 years
Where it is running
- University of Colorado Anschutz — Aurora, Colorado, United States
- R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Hennepin Healthcare — Minneapolis, Minnesota, United States
- Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
- The Ohio State University — Columbus, Ohio, United States
- Vanderbilt University — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.