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

ClinicalTrials.gov ID

NCT07584252

Lead Sponsor

Stephanie Di StasiOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

804Estimated

Last Update Posted

May 13, 2026Actual

Start Date

Jul 1, 2026Estimated

Primary Completion Date

Aug 1, 2030Estimated

Completion Date

Mar 1, 2032Estimated

Official Title

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

Brief 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).

• Trauma Blunt
• Orthopedic

• Comprehensive trauma recovery programming (C-TRP)
• Standard of Care (Investigator Selected)

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Patients:

Inclusion Criteria:

1. Age >= 18 years
2. Anticipated hospital length of stay > 72 hours
3. Moderate to severe orthopaedic trauma treated surgically for 1 or more injuries
4. GCS >= 13 at the time of enrollment
5. Willing and able to meet with Evellere coach while hospitalized or via the telephone within 72 hours of discharge (intervention cohort only)

Exclusion Criteria:

1. Non-english speaking (must be sufficiently fluent in English to consent and complete surveys without interpretive services)
2. Prior to index hospitalization, patient must not be receiving home services or be independent in daily tasks
3. Any penetrating brain injury
4. Patients with significant burn injury
5. Prior cognitive impairment
6. Hospital death or imminent death
7. 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
8. Prisoner/ inmate or police/ security intervention during hospitalization
9. No reliable internet access at baseline
10. Psychosis
11. Trauma presentation is a result of suicide attempt/ self-harm

Care Partners

Inclusion criteria:

1. Identified by the enrolled patient as a primary source of support during their recovery. A care partner can be in person or supporting remotely.
2. Age >= 18 years
3. 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:

1. Non-english speaking (must be sufficiently fluent in English to consent and complete surveys without interpretive services)
2. Paid professionals or home healthcare providers whose support is provided as part of employment (e.g., nurses, aides, case managers)
3. Already enrolled as a care partner for another participant in the HEART Trial
4. Hospitalized at time of patient enrollment
5. No reliable internet access at baseline

Healthcare Workers

Inclusion criteria:

1. Age > 18 years
2. Currently employed (full-time, part-time) at a participating trauma center in a role type associated with trauma care (e.g., engaged in clinical care navigation, behavioral health, rehabilitation, recovery coordination, etc.)
3. Provides or supports care for orthopedic trauma patients for ≥20% of their clinical time
4. Expected to remain employed at the trauma center for >12 months after enrollment

Exclusion criteria:

1. Are contracted staff or traveling temporary staff
2. Are students or trainees
3. No reliable internet access at baseline

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Sequential Assignment

Masking

None (Open Label)

Lead Sponsor

Stephanie Di StasiOTHER

Collaborators

Patient-Centered Outcomes Research InstituteOTHER

MGage@som.umaryland.edu4104486400

Emily.Wagstrom@hcmed.org6148736963

Ida.Leah.Gitajn@hitchcock.org603-650-5133

carmen.quatman@osumc.edu614-293-2663

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