Orthopedic, Trauma Blunt
Conditions
Keywords
Healing and Empowerment Actions for Recovery from Trauma Trial (HEART), Comprehensive trauma recovery programming (C-TRP), Trauma recovery programming (TRP)
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).
Interventions
BEHAVIORALComprehensive 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.
Sponsors
Stephanie Di Stasi
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients: Inclusion Criteria: 1. Age \>= 18 years 2. Anticipated hospital length of stay \> 72 hours 3. Moderate to severe orthopaedic trauma treated surgically for 1 or more injuries 4. GCS \>= 13 at the time of enrollment 5. Willing and able to meet with Evellere coach while hospitalized or via the telephone within 72 hours of discharge (intervention cohort only)
Exclusion criteria
1. Non-english speaking (must be sufficiently fluent in English to consent and complete surveys without interpretive services) 2. Prior to index hospitalization, patient must not be receiving home services or be independent in daily tasks 3. Any penetrating brain injury 4. Patients with significant burn injury 5. Prior cognitive impairment 6. Hospital death or imminent death 7. 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 8. Prisoner/ inmate or police/ security intervention during hospitalization 9. No reliable internet access at baseline 10. Psychosis 11. Trauma presentation is a result of suicide attempt/ self-harm Care Partners Inclusion criteria: 1. Identified by the enrolled patient as a primary source of support during their recovery. A care partner can be in person or supporting remotely. 2. Age \>= 18 years 3. Willing and able to meet with an Evellere coach during patient hospitalization or via telephone within 72 hours of discharge (intervention cohort only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS-Anxiety | 5-7 weeks and 12-14 weeks post enrollment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maslach Burnout Inventory | 6 months and 12 months | The primary outcome for Aim 3 (healthcare workers) is burnout, measured using Maslach Burnout Inventory (MBI) at 6 months and 12 months. |
Countries
United States
Outcome results
None listed