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Not yet recruitingNCT07829510Updated Sep 21, 2026

Transforming Trauma Care

An interventional study of Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0) in Post-Traumatic Stress Disorder (PTSD), Depression and Substance Use Disorder, sponsored by Medical University of South Carolina. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-21.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study evaluates the implementation and clinical effectiveness of the Trauma Resilience and Recovery Program (TRRP 2.0), a technology-enhanced behavioral health intervention designed for trauma center patients. TRRP 2.0 integrates screening, monitoring, and referral services for posttraumatic stress disorder (PTSD), depression, and substance use disorder (SUD).

The study uses a two-phase design across two trauma centers: a usual care phase followed by implementation of TRRP 2.0. A total of 300 adult trauma patients will be recruited and followed for 3 months to assess behavioral health service utilization and clinical outcomes.

Read the detailed description

Each year, over 600,000 of the 3 million U.S. patients hospitalized for traumatic injuries develop PTSD or depression within a year post-injury. Despite the 2022 American College of Surgeons (ACS) mandate for routine mental health screening and treatment, many trauma centers struggle to implement effective programs due to a lack of clear implementation roadmaps and operational barriers. The Trauma Resilience and Recovery Program (TRRP), developed by the Medical University of South Carolina (MUSC), addresses these gaps with a comprehensive, evidence-based intervention designed to meet the behavioral health needs of trauma patients. TRRP includes a web-based, HIPAA-compliant provider navigator platform that is cost-efficient and unique in its ability to facilitate improved screening accuracy at the bedside and efficient screening and referral post-discharge. The TRRP model and navigator platform have been used and sustained at MUSC since 2015 and have been adopted by over a dozen trauma centers. However, while adopters have noted several benefits of the platform, they emphasize two top-priority needs to facilitate adherence to ACS guidelines, ensure workload efficiencies that reduce provider burden, and minimize patient data capture errors: 1) integration of resources to facilitate screening and intervention for substance use disorders (SUD), and 2) the ability to read from and write to the electronic medical record (EMR). In this Phase I STTR, FRD Accel will partner with the MUSC team to enhance and de-risk an upgraded navigation platform-TRRP 2.0-to improve its scalability nationally in preparation for commercial launch. Our upgraded TRRP 2.0 platform will add features for integrated screening, intervention, and referral for SUD in addition to PTSD and depression. This will reduce provider burden and ensure compliance with ACS guidelines, promoting comprehensive care and optimizing patient outcomes. The specific aims for Phase I STTR are to 1) improve the TRRP platform by integrating new resources to facilitate the screening and referral of trauma patients with SUD and enabling communication with the Epic EMR (months 1-8), and 2) evaluate the clinical effectiveness of the TRRP 2.0 platform on post-discharge follow-up, behavioral health service utilization, and mental health outcomes among a sample of 300 adult trauma injury survivors (months 3-22). Successful completion of Phase I will validate TRRP 2.0's capacity to meet trauma centers' needs for integrated behavioral health services. The anticipated results will demonstrate the platform's ability to enhance patient care, streamline provider workflows, and ensure adherence to ACS standards. This will justify the transition to Phase II, where we will focus on broader dissemination, further development, and commercialization of the platform to maximize its impact across trauma centers nationwide.

02

Conditions studied

  • Post-Traumatic Stress Disorder (PTSD)
  • Depression
  • Substance Use Disorder
  • Traumatic Injury

Keywords

  • Trauma care
  • Behavioral health
  • Post-Traumatic Stress Disorder (PTSD)
  • Depression
  • Substance use
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults aged ≥18 years
  • Admitted to a trauma center for ≥24 hours following injury
  • English- or Spanish-speaking

Exclusion criteria

Exclusion Criteria:

  • Moderate to severe cognitive impairment
  • Active psychosis
  • Injury preventing verbal communication
  • Self-inflicted injury
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Active comparator
    Usual Care

    ACS adherent usual care for SBIRT and Behavioral Health Screening and Referral

    Behavioral: Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)

  • Experimental
    TRRP 2.0

    Service delivery via TRRP 2.0

    Behavioral: Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)

Interventions

  • BehavioralTrauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)

    TRRP 2.0 is an enhanced, technology-supported behavioral health care model for patients hospitalized after traumatic injury. The intervention includes bedside behavioral health and substance use screening, education about emotional recovery, enrollment in post-discharge follow-up services, automated symptom monitoring and education via text messaging, follow-up behavioral health screening, and referral to treatment when indicated. The TRRP 2.0 provider navigation platform supports delivery and tracking of these services and includes integrated substance use screening/intervention resources and Epic electronic medical record read/write functionality.

05

What researchers measure

Primary outcomes

  1. Posttraumatic Stress Symptom Severity as Measured by the PCL-8

    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.

    Time frame: 3-month post-baseline

  2. Number of Participants Screening Positive for Posttraumatic Stress Risk on the Injured Trauma Survivor Screen (ITSS)

    Posttraumatic stress risk is assessed using the ITSS. Five items are scored yes=1 and no=0 and summed. Participants with a score of 2 or greater are classified as screening positive for risk of posttraumatic stress.

    Time frame: Baseline

  3. Change in Psychological Distress as Measured by the Kessler-6 (K6)

    The Kessler 6 (K6; Kessler et al., 2003) is a screening scale for nonspecific distress to discriminate cases of several mental illness. Items are rated on a 5-point Likert scale (1-5). Total scores range from 6-30 and are calculated as the sum of all item ratings, with a total score ³ 13 indicating severe mental illness. This measure has been shown to have strong psychometric properties.

    Time frame: Baseline, 3-month postbaseline

  4. Depressive Symptom Severity as Measured by the PHQ-8

    The Patient Health Questionniare-9 (PHQ-9; Kroenke, Spitzer, \& Williams, 2001) assesses the presence and frequency of 9 core depressive symptoms. Items are rated on a 4-point Likert scale (0-3). Total scores range from 0-27 and are calculated as the sum of all item ratings, with a total score of ≥ 10 indicating clinical significance.

    Time frame: 3 months postbaseline

  5. Frequency of Alcohol Use as Measured by the NIDA Quick Screen

    The NIDA Quick Screen (NIDA, 2010) is a validated instrument designed to assist providers in screening adults for substance use. The screen simply inquires whether a participant has used drugs (mood-altering, illegal, or prescription for nonmedical reasons), alcohol, or tobacco products within the past year and how often these substances have been used.

    Time frame: 3 months postbaseline

  6. General Life Satisfaction as Measured by PROMIS General Life Satisfaction

    The 10-item PROMIS General Life Satisfaction questionnaire (Salsman et al., 2014) measures one's perception of life experiences and whether one likes his/her life or not.

    Time frame: 3 months postbaseline

  7. Frequency of Tobacco Use as Measured by the NIDA Quick Screen

    Tobacco use is assessed using the NIDA Quick Screen. Participants report the frequency of tobacco product use during the past year using the response categories never, once or twice, monthly, weekly, or daily/almost daily.

    Time frame: 3 months postbaseline

  8. Frequency of Prescription Drug Use for Nonmedical Reasons as Measured by the NIDA Quick Screen

    Nonmedical prescription drug use is assessed using the NIDA Quick Screen. Participants report frequency of prescription drug use for nonmedical reasons during the past year using the response categories never, once or twice, monthly, weekly, or daily/almost daily.

    Time frame: 3 months postbaseline

  9. Frequency of Illegal Drug Use as Measured by the NIDA Quick Screen

    Illegal drug use is assessed using the NIDA Quick Screen. Participants report frequency of illegal drug use during the past year using the response categories never, once or twice, monthly, weekly, or daily/almost daily.

    Time frame: 3 months postbaseline

  10. Number of Participants Screening Positive for Depression Risk on the Injured Trauma Survivor Screen (ITSS)

    Depression risk is assessed using the ITSS. Five items are scored yes=1 and no=0 and summed. Participants with a score of 2 or greater are classified as screening positive for risk of depression.

    Time frame: Baseline

Secondary outcomes

  1. Hospital Length of Stay

    Length of stay for the index traumatic injury hospitalization will be obtained from the electronic medical record and reported in days.

    Time frame: Baseline

  2. Electronic Medical Record Data

    Data will be collected at baseline via the electronic medical record including patients' length of stay; injury severity scores; number of emergency department visits; and opioid, anti-anxiety and anti-depression medications prescribed.

    Time frame: Baseline

  3. National Health Interview Survey Adult Access to Health Care and Utilization Module

    This protocol includes 10 interviewer-administered questions from the National Health Interview Survey (NHIS) Adult Access to Health Care \& Utilization Module (CDC, 2019) designed to assess when medical care was last sought, usual place of care, frequency of getting medical treatment.

    Time frame: 3 months postbaseline

  4. Injury Severity Score (ISS)

    Injury Severity Score associated with the index traumatic injury will be obtained from the electronic medical record. ISS ranges from 1 to 75, with higher scores indicating greater injury severity.

    Time frame: Baseline

  5. Number of Emergency Department Visits

    Number of emergency department visits occurring during the specified period will be obtained from the electronic medical record.

    Time frame: 3 months postbaseline

  6. Number of Participants Prescribed Opioid Medication

    Number of participants with an opioid medication prescription documented in the electronic medical record during the specified period.

    Time frame: 3 months postbaseline

  7. Number of Participants Prescribed Anti-Anxiety Medication

    Number of participants with an anti-anxiety medication prescription documented in the electronic medical record during the specified period.

    Time frame: 3 months postbaseline

  8. Number of Participants Prescribed Antidepressant Medication

    Number of participants with an antidepressant medication prescription documented in the electronic medical record during the specified period.

    Time frame: 3 months postbaseline

06

Study locations

No study locations are listed for this record.

07

References and documents

Study documents

  • Study protocol · Jul 7, 2026
  • Statistical analysis plan · Jul 7, 2026
  • Informed consent form · Jul 7, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

08

Registry details

Key details

Study ID
NCT07829510
Lead sponsor
Medical University of South Carolina
Responsible party
Tatiana Davidson (Professor-Faculty, Medical University of South Carolina) — Principal investigator
First posted
Sep 21, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
May 1, 2028 (estimated)
Completion
Aug 30, 2028 (estimated)
Last update
Sep 21, 2026

Study contacts

Tatiana Davidson, PhD
Contact
davidst@musc.edu
8437920979
Sarah German, MA
Contact
germansa@musc.edu
8437920979
Tatiana Davidson, PhD
principal investigator · Medical University of South Carolina

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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