Transforming Trauma Care
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged ≥18 years
Admitted to a trauma center for ≥24 hours following injury
English- or Spanish-speaking
Disqualifiers
Moderate to severe cognitive impairment
Active psychosis
Injury preventing verbal communication
Self-inflicted injury
Trial design
Design model
Sequential
Treatments tested in this trial
Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)
BehavioralTRRP 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.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Usual CareActive comparator 1 intervention
Group B: TRRP 2.0Experimental treatment 1 intervention
Trial outcomes
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-baseline2
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
Baseline3
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 postbaseline4
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 postbaselineSecondary 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
Baseline2
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
Baseline3
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 postbaseline4
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
BaselineLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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