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

Overview

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).

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 ensu
• 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 respo

Primary outcome measures

• PROMIS-Anxiety [Time frame: 5-7 weeks and 12-14 weeks post enrollment]

Secondary outcome measures (1)

• Maslach Burnout Inventory [Time frame: 6 months and 12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 7 centers

• University of Colorado Anschutz — Aurora
• R Adams Cowley Shock Trauma Center — Baltimore
• Johns Hopkins University — Baltimore
• Hennepin Healthcare — Minneapolis
• Dartmouth Hitchcock Medical Center — Lebanon
• The Ohio State University — Columbus
• Vanderbilt University — Nashville

Identifiers

NCT: NCT07584252 · BPS-2024C3-41889

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗