NCT07584252

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).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
804

participants targeted

Target at P75+ for not_applicable

Timeline
69mo left

Started Jul 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

7 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Expected
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2032

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

4.1 years

First QC Date

May 7, 2026

Last Update Submit

May 7, 2026

Conditions

Trauma BluntOrthopedic

Keywords

Healing and Empowerment Actions for Recovery from Trauma Trial (HEART)Comprehensive trauma recovery programming (C-TRP)Trauma recovery programming (TRP)

Outcome Measures

Primary Outcomes (1)

  • PROMIS-Anxiety

    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

    5-7 weeks and 12-14 weeks post enrollment

Secondary Outcomes (1)

  • Maslach Burnout Inventory

    6 months and 12 months

Study Arms (2)

Trauma recovery Programming (TRP)

ACTIVE COMPARATOR

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.

Other: Standard of Care (Investigator Selected)

Comprehensive trauma recovery programming (C-TRP)

EXPERIMENTAL

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 ca

Behavioral: Comprehensive trauma recovery programming (C-TRP)

Interventions

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.

Trauma recovery Programming (TRP)
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

Comprehensive trauma recovery programming (C-TRP)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • 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)
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

R Adams Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Hennepin Healthcare

Minneapolis, Minnesota, 55404, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Wounds, Nonpenetrating

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor, Health and Rehabilitation Sciences

Study Record Dates

First Submitted

May 7, 2026

First Posted

May 13, 2026

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

March 1, 2032

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(7)