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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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)â„¢ model, supporting collaboration with health systems and addressing psychosocial needs while enabling medical teams to focus on physical trauma ca |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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)â„¢ model, supporting collaboration with health systems and addressing psychosocial needs while enabling medical teams to focus on physical trauma car |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months and 12 months |
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Care Partners
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Healthcare Workers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz | Aurora | Colorado | 80045 | United States |
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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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| 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. |
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| R Adams Cowley Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
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| Johns Hopkins University | Baltimore | Maryland | 21218 | United States |
| Hennepin Healthcare | Minneapolis | Minnesota | 55404 | United States |
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| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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| The Ohio State University | Columbus | Ohio | 43210 | United States |
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| Vanderbilt University | Nashville | Tennessee | 37203 | United States |
| ID | Term |
|---|---|
| D014949 | Wounds, Nonpenetrating |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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