Trauma BluntHEARTNCT07584252
The Healing and Empowerment Actions for Recovery From Trauma (HEART) Trial
A study testing Comprehensive trauma recovery programming (C-TRP) in people with Trauma Blunt and Orthopedic, run by Stephanie Di Stasi at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma Blunt, Orthopedic
- What is being tested?
- Comprehensive trauma recovery programming (C-TRP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 804 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Jul 2026to 1 Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
- Identified by the enrolled patient as a primary source of support during their recovery. A care partner can be in person or supporting remotely.
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- 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)
- 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
Who cannot join
- 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
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- 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
- 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
- Are contracted staff or traveling temporary staff
- Are students or trainees
- No reliable internet access at baseline
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites
University of Colorado Anschutz
Aurora, Colorado, 80045
Nicholas Alfonso, MD, 7208481900
R Adams Cowley Shock Trauma Center
Baltimore, Maryland, 21201
Mark Gage, MD, 4104486400, MGage@som.umaryland.edu
Johns Hopkins University
Baltimore, Maryland, 21218
The Ohio State University
Columbus, Ohio, 43210
Carmen Quatman, MD, 614-293-2663, carmen.quatman@osumc.edu
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Leah Gitajn, MD, 603-650-5133, Ida.Leah.Gitajn@hitchcock.org
Hennepin Healthcare
Minneapolis, Minnesota, 55404
Emily Wagstrom, MD, 6148736963, Emily.Wagstrom@hcmed.org
Vanderbilt University
Nashville, Tennessee, 37203
About this study
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).
- Conditions
- Trauma Blunt, Orthopedic
- Being tested
- Comprehensive trauma recovery programming (C-TRP), Standard of Care (Investigator Selected)
- Keywords
- Healing and Empowerment Actions for Recovery from Trauma Trial (HEART), Comprehensive trauma recovery programming (C-TRP), Trauma recovery programming (TRP)
- Medical subject headings
- Wounds, Nonpenetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive trauma recovery programming (C-TRP)Behavioural
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
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Standard of Care (Investigator Selected) |
| 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)™ model, supporting collaboration with health systems and addressing psychosocial needs while enabling medical teams to focus on physical trauma ca Receives: Behavioral: Comprehensive trauma recovery programming (C-TRP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5-7 weeks and 12-14 weeks post enrollment
Secondary outcomes (1)
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.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma BluntStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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).
- Masking
- None (open label)
- Enrolment
- 804 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stephanie Di Stasi
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor-investigator, Stephanie Di Stasi, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07584252
- Sponsor's protocol ID
- BPS-2024C3-41889
- Acronym
- HEART
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Healing and Empowerment Actions for Recovery From Trauma (HEART) Trial
- ClinicalTrials.gov ID
- NCT07584252
- Acronym / sponsor ID
- HEART / BPS-2024C3-41889
- Conditions
- Trauma Blunt, Orthopedic
- Keywords
- Healing and Empowerment Actions for Recovery from Trauma Trial (HEART), Comprehensive trauma recovery programming (C-TRP), Trauma recovery programming (TRP)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 804 participants (estimated)
- Lead sponsor
- Stephanie Di StasiUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Mar 2032 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Trauma recovery Programming (TRP) | Active comparator | 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 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. |
| Comprehensive trauma recovery programming (C-TRP) | Experimental | 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 ca |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Behavioural | Comprehensive trauma recovery programming (C-TRP) |
| 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 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 | Trauma recovery Programming (TRP) |
Primary outcome
PROMIS-Anxiety
Time frame: 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
1 secondary outcome
Maslach Burnout Inventory
Time frame: 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive trauma recovery programming (C-TRP) in people with Trauma Blunt and Orthopedic, run by Stephanie Di Stasi at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PROMIS-Anxiety (time frame: 5-7 weeks and 12-14 weeks post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.