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

7. Mai 2026 aktualisiert von: Stephanie Di Stasi
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).

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

804

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Colorado
      • Aurora, Colorado, Vereinigte Staaten, 80045
        • University of Colorado Anschutz
        • Kontakt:
          • Nicholas Alfonso, MD
          • Telefonnummer: 7208481900
    • Maryland
      • Baltimore, Maryland, Vereinigte Staaten, 21218
        • Johns Hopkins University
      • Baltimore, Maryland, Vereinigte Staaten, 21201
        • R Adams Cowley Shock Trauma Center
        • Kontakt:
    • Minnesota
      • Minneapolis, Minnesota, Vereinigte Staaten, 55404
    • New Hampshire
      • Lebanon, New Hampshire, Vereinigte Staaten, 03756
    • Ohio
      • Columbus, Ohio, Vereinigte Staaten, 43210
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37203
        • Vanderbilt University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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)

Exclusion criteria:

  1. Non-english speaking (must be sufficiently fluent in English to consent and complete surveys without interpretive services)
  2. Paid professionals or home healthcare providers whose support is provided as part of employment (e.g., nurses, aides, case managers)
  3. Already enrolled as a care partner for another participant in the HEART Trial
  4. Hospitalized at time of patient enrollment
  5. No reliable internet access at baseline

Healthcare Workers

Inclusion criteria:

  1. Age > 18 years
  2. 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.)
  3. Provides or supports care for orthopedic trauma patients for ≥20% of their clinical time
  4. Expected to remain employed at the trauma center for >12 months after enrollment

Exclusion criteria:

  1. Are contracted staff or traveling temporary staff
  2. Are students or trainees
  3. No reliable internet access at baseline

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Sequenzielle Zuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Trauma recovery Programming (TRP)
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.
Sonstiges: 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.
Experimental: 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
Verhalten: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PROMIS-Anxiety
Zeitfenster: 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
5-7 weeks and 12-14 weeks post enrollment

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Maslach Burnout Inventory
Zeitfenster: 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.
6 months and 12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Stephanie Di Stasi

Mitarbeiter

Patient-Centered Outcomes Research Institute

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. Juli 2026

Primärer Abschluss (Geschätzt)

1. August 2030

Studienabschluss (Geschätzt)

1. März 2032

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. Mai 2026

Zuerst gepostet (Tatsächlich)

13. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

13. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • BPS-2024C3-41889

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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