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NOT YET RECRUITING
NCT07584252
NA

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

Sponsor: Stephanie Di Stasi

View on ClinicalTrials.gov

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).

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

804

Start Date

2026-07-01

Completion Date

2032-03-01

Last Updated

2026-05-13

Healthy Volunteers

No

Interventions

BEHAVIORAL

Comprehensive trauma recovery programming (C-TRP)

A multicomponent, patient-focused intervention that follows the standardized recovery protocol (TRP) with added resiliency coaching, peer support, education, and navigation resources. C-TRP begins during hospitalization and continues throughout recovery, allowing patients and care-partners to engage based on their needs and preferences. Upon enrollment, patients are connected with a local resiliency coach from Evellere for optional in-person support. Coaching provides a holistic approach to ensure safety, connection, and recovery planning, including referrals to site-specific or community providers for depression, anxiety, or PTSD as needed. Education is delivered through online resources, print materials, mobile apps, and peer and coach guidance. The intervention is delivered by Evellere using the Trauma Responsive Continuum of Care (TRCC)™ model, supporting collaboration with health systems and addressing psychosocial needs while enabling medical teams to focus on physical trauma car

OTHER

Standard of Care (Investigator Selected)

Every trauma system adheres to a standardized protocol, aligned with credentialing requirements of ATS and The Joint Commission. Locally, this involves tailored referrals by hospital teams at time of discharge, based on specific needs of the patient. Additionally, a standard after-visit summary, with discharge instructions, is provided to the patient. It is a routine practice for the discharge team to review these instructions with the patient to address any questions. After discharge, the responsibility for managing the recovery process shifts to the patient and/or their care-partner. This includes calling physician offices for specific questions. However, social services and resources to navigate the process are limited after discharge.

Locations (7)

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