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

ConditionsTrauma Blunt Orthopedic

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorStephanie Di Stasi

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

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 intervention
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.

Treatment groups

804 Participants

are divided into 2 treatment groups

Group A: Trauma recovery Programming (TRP)Active comparator 1 intervention

Group B: Comprehensive trauma recovery programming (C-TRP)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

5-7 weeks and 12-14 weeks post enrollment

Secondary outcomes

Maslach Burnout Inventory

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

Time frame

6 months and 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stephanie Di Stasi

Lead sponsor

Ohio State University

Sponsor institution

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: