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NCT Number: NCT07584252

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

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Key information

Conditions

Trauma Blunt Orthopedic Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Anschutz, Aurora, Colorado, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients:

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)
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
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.)
Provides or supports care for orthopedic trauma patients for ≥20% of their clinical time
Expected to remain employed at the trauma center for >12 months after enrollment

Exclusion criteria

Are contracted staff or traveling temporary staff
Are students or trainees
No reliable internet access at baseline

Treatment and study plan

Comprehensive trauma recovery programming (C-TRP)

Behavioral

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

Standard of Care (Investigator Selected)

Other

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.

Primary outcomes

PROMIS-Anxiety

Time frame: 5-7 weeks and 12-14 weeks post enrollment

The primary outcome for aims 1 (patients) and 2 (care partners) is anxiety, measured using PROMIS-Anxiety at 5-7 weeks and 12-14 weeks post-enrollment

Secondary outcomes

Maslach Burnout Inventory

Time frame: 6 months and 12 months

The primary outcome for Aim 3 (healthcare workers) is burnout, measured using Maslach Burnout Inventory (MBI) at 6 months and 12 months.

Sponsors and collaborators

Lead sponsor

Stephanie Di Stasi

Other

Collaborators

Patient-Centered Outcomes Research Institute

Registry information

Acronym: HEART

Important dates

Study start: 2026
Primary completion: 2030
Study completion: 2032
First posted: May 13, 2026
Registry last updated: May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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