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NCT Number: NCT07829510

Transforming Trauma Care

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)

Behavioral

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.

Primary outcomes

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

    Time frame: 3-month post-baseline

    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.

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

    Time frame: Baseline

    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.

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

    Time frame: Baseline, 3-month postbaseline

    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.

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

    Time frame: 3 months postbaseline

    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.

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

    Time frame: 3 months postbaseline

    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.

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

    Time frame: 3 months postbaseline

    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.

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

    Time frame: 3 months postbaseline

    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.

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

    Time frame: 3 months postbaseline

    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.

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

    Time frame: 3 months postbaseline

    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.

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

    Time frame: Baseline

    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.

Secondary outcomes

  1. Hospital Length of Stay

    Time frame: Baseline

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

  2. Electronic Medical Record Data

    Time frame: Baseline

    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.

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

    Time frame: 3 months postbaseline

    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.

  4. Injury Severity Score (ISS)

    Time frame: Baseline

    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.

  5. Number of Emergency Department Visits

    Time frame: 3 months postbaseline

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

  6. Number of Participants Prescribed Opioid Medication

    Time frame: 3 months postbaseline

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

  7. Number of Participants Prescribed Anti-Anxiety Medication

    Time frame: 3 months postbaseline

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

  8. Number of Participants Prescribed Antidepressant Medication

    Time frame: 3 months postbaseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah German, MA

CONTACT

[email protected]

8437920979

Tatiana Davidson, PhD

CONTACT

[email protected]

8437920979

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

Transforming Trauma Care: Innovative Solutions for Enhancing Behavioral Health Outcomes

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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