An interventional study of Comprehensive trauma recovery programming (C-TRP) and Standard of Care (Investigator Selected) in Trauma Blunt and Orthopedic, sponsored by Stephanie Di Stasi. Not yet recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by Stephanie Di Stasi · Not applicable, Interventional, and Treatment
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).
37 studies on the registry are indexed under Wounds, Nonpenetrating; 11 are open to participants now.
This study's planned enrollment of 804 is above the median of 120 across 15 interventional studies indexed under Wounds, Nonpenetrating.
Browse Wounds, Nonpenetrating studies →This is the only study on the registry with Stephanie Di Stasi as lead sponsor.
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Patients:
Inclusion Criteria:
Exclusion Criteria:
Care Partners
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Healthcare Workers
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Exclusion criteria:
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)
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)
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
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.
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
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
Plan to share: No
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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