Not Yet RecruitingNot Applicable

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

United States804 participantsStarted 2026-07-01

Plain-language 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).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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)

Exclusion criteria

. Non-english speaking (must be sufficiently fluent in English to consent and complete surveys without interpretive services)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is focused on measuring anxiety outcomes after a blunt orthopedic trauma — given my specific injury and current mental health needs, does it make sense for me to look into a trial like this, or should I focus first on my physical recovery?
2Since this trial isn't recruiting yet, how long might it realistically be before enrollment opens, and is there anything I should be doing in the meantime to address trauma-related anxiety?
3The trial seems to measure anxiety using a tool called PROMIS-Anxiety rather than a physical recovery outcome — does that mean this study is primarily about my emotional and psychological recovery after injury, and would that address a real gap in my current care plan?
4Because this trial is listed as Phase NA, which often means it's testing a behavioral or psychosocial approach rather than a drug, can you help me understand what kind of intervention I might actually be participating in and what it would involve day-to-day?
5Are there existing programs or therapies for trauma-related anxiety after orthopedic injury that I could access right now, while this trial is still in the pre-recruitment stage?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

PROMIS-Anxiety

Timeframe: 5-7 weeks and 12-14 weeks post enrollment

Trial details

NCT IDNCT07584252

SponsorStephanie Di Stasi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-08-01

View on ClinicalTrials.gov More Trauma Blunt trials