Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury
2 other identifiers
interventional
350
1 country
1
Brief Summary
The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2022
CompletedFirst Posted
Study publicly available on registry
August 11, 2022
CompletedStudy Start
First participant enrolled
November 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
September 4, 2025
September 1, 2025
4.4 years
August 5, 2022
September 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Change from Baseline PTSD Checklist for DSM-5 8- item (PCL8-5) at 3-,6-, and 12-month
The PTSD Checklist for DSM-5 (Weathers et al., 2013) is a self-report measure that assesses the extent to which participants are bothered by the DSM-5 PTSD symptoms. Each symptom is rated on a scale of 0 (not at all) to 4 (extremely). Total scores are obtained by summing the scores of all items. The 8-item adaptation includes assessment of intrusive thoughts, avoidance of external reminders, negative expectations of self/ world, easily startled, emotional cue reactivity, avoidance of thoughts/emotions, loss of interest, and difficulty concentrating. The PCL8-5 has strong psychometric properties and clinical utility data similar to that of the long version.
Baseline, 3-, 6-, and 12- months post-baseline
Secondary Outcomes (23)
Demographics
Baseline
Injured Trauma Survivor Screen (ITSS)
Baseline
Electronic Medical Record Data (EMR)
Baseline
The Kessler 6 (K6)
Baseline, 3-, 6-, and 12- months post-baseline
Patient Health Questionnaire-9 (PHQ-9)
3-, 6-, and 12-months post- baseline assessment
- +18 more secondary outcomes
Study Arms (2)
Trauma Resilience and Recovery Program
EXPERIMENTALTRRP is a stepped model of care that delivers education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (Step 1), fosters symptom monitoring and continued education (Step 2), screens for PTSD and depression 30 days post-injury (Step 3), and provides a referral and warm handoff to mental health services if needed (Step 4)
Enhanced Usual Care Condition
NO INTERVENTIONPatients in the EUC arm will be given education about mental health after traumatic injury, educational materials about mental health recovery, and local referral information to assist treatment-seeking patients in seeking care.
Interventions
The Trauma Resilience and Recovery Program is a stepped model of care that is designed to deliver education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and continued education (Step 2), screen for PTSD and depression 30 days post-injury (Step 3), and provide a referral and warm handoff to mental health services if needed (Step 4).
Eligibility Criteria
You may qualify if:
- English- or Spanish-speaking patients ≥ 16 years old who are admitted to George Washington University hospital's trauma center and screen positive on the Injured Trauma Survivors Screen (which indicates risk for development of posttraumatic stress disorder and/or depression) will be included.
You may not qualify if:
- Patients who have a Glasgow Coma Scale score under 13 at hospital admission, moderate to severe cognitive impairment (as measured by the Montreal Cognitive Assessment), active psychosis, or injury that prevents verbal communication (e.g., serious head or spinal cord injury) or is self-inflicted will be excluded. Patients with positive substance use screens via GWU's SBIRT protocol (\~7% of the patient population) will be assessed by the clinical team with reference to severity and recency of substance use problems. We have found at MUSC that a high percentage of patients with SBIRT- positive screens are nevertheless good candidates for TRRP (\>85%), but patients with serious, active substance abuse problems are likely not good candidates for TRRP and therefore will be excluded and referred to a substance use treatment center.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
George Washington University Hospital
Washington, Virginia, 20037, United States
Related Publications (1)
Espeleta HC, Witcraft SM, Raffa T, Kartiko S, Dawson D, Becerra G, Roisman H, Hughes-Halbert C, Mueller M, Powell E, Brock T, Sarani B, Ruggiero KJ. Hybrid 1 randomized controlled trial of an integrated stepped-care mental health intervention for traumatic injury patients. Contemp Clin Trials. 2024 Nov;146:107694. doi: 10.1016/j.cct.2024.107694. Epub 2024 Sep 17.
PMID: 39299544BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth Ruggiero, PhD
Medical University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 5, 2022
First Posted
August 11, 2022
Study Start
November 4, 2022
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
September 4, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will become available Year 3 quarter 3 of the study
- Access Criteria
- REDCap data dictionaries can be distributed for reuse at multiple institutions. A library of data dictionaries is made available for standards-based data collection forms and validated instruments. The underlying database is hosted in a secure data center at MUSC, a secure environment for data systems and servers on campus, and includes redundancy, failover capability, backups and extensive security checks.
First, we will analyze the qualitative and quantitative data from our interviews and randomized controlled trial and will share these data via The National Database for Clinical Trials Related to Mental Illness. We will prepare both brief and comprehensive reports for AHRQ as we have done in prior NIH studies. We also will disseminate reports of our findings via print copy to the MUSC and GWU Public Relations office and websites. Additionally, we will prepare manuscripts for submission to research journals, such as JAMA, JAMA Surgery, JAMA Psychiatry, Am J Psychiatry, J Trauma and Acute Care Surgery, J Am College of Surgeons, Am J Public Health, and other sources that ensure broad dissemination. Additionally, as we have done previously with other federally funded grants, we will seek to present our findings to AHRQ staff and at national and international conferences.