[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656811":3},{"organization":4,"outcomesModule":7,"designInfo":69,"detailedDescription":76,"studyPopulation":68,"armGroups":77,"interventions":89,"overallOfficials":95,"centralContacts":99,"locations":68,"responsibleParty":107,"collaborators":68,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":68,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":68,"enrollmentInfo":120,"targetDuration":68,"studyType":123,"phases":124,"briefSummary":126,"conditions":127,"keywords":132,"overallStatus":136,"whyStopped":68,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":68},{"fullName":5,"class":6},"Medical University of South Carolina","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":43,"otherOutcomes":68},[9,13,17,21,25,28,31,34,37,40],{"measure":10,"description":11,"timeFrame":12},"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\u002F world, easily startled, emotional cue reactivity, avoidance of thoughts\u002Femotions, loss of interest, and difficulty concentrating.","3-month post-baseline",{"measure":14,"description":15,"timeFrame":16},"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.","Baseline",{"measure":18,"description":19,"timeFrame":20},"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.","Baseline, 3-month postbaseline",{"measure":22,"description":23,"timeFrame":24},"Depressive Symptom Severity as Measured by the PHQ-8","The Patient Health Questionniare-9 (PHQ-9;\n\nKroenke, Spitzer, \\& Williams, 2001) assesses\n\nthe presence and frequency of 9 core depressive\n\nsymptoms. Items are rated on a 4-point Likert\n\nscale (0-3). Total scores range from 0-27 and are\n\ncalculated as the sum of all item ratings, with a\n\ntotal score of ≥ 10 indicating clinical significance.","3 months postbaseline",{"measure":26,"description":27,"timeFrame":24},"Frequency of Alcohol Use as Measured by the NIDA Quick Screen","The NIDA Quick Screen (NIDA, 2010) is a\n\nvalidated instrument designed to assist providers\n\nin screening adults for substance use. The screen\n\nsimply inquires whether a participant has used\n\ndrugs (mood-altering, illegal, or prescription\n\nfor nonmedical reasons), alcohol, or tobacco\n\nproducts within the past year and how often these\n\nsubstances have been used.",{"measure":29,"description":30,"timeFrame":24},"General Life Satisfaction as Measured by PROMIS General Life Satisfaction","The 10-item PROMIS General Life Satisfaction\n\nquestionnaire (Salsman et al., 2014) measures\n\none's perception of life experiences and whether\n\none likes his\u002Fher life or not.",{"measure":32,"description":33,"timeFrame":24},"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\u002Falmost daily.",{"measure":35,"description":36,"timeFrame":24},"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\u002Falmost daily.",{"measure":38,"description":39,"timeFrame":24},"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\u002Falmost daily.",{"measure":41,"description":42,"timeFrame":16},"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.",[44,47,50,53,56,59,62,65],{"measure":45,"description":46,"timeFrame":16},"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.",{"measure":48,"description":49,"timeFrame":16},"Electronic Medical Record Data","Data will be collected at baseline via the electronic\n\nmedical record including patients' length of stay;\n\ninjury severity scores; number of emergency\n\ndepartment visits; and opioid, anti-anxiety and\n\nanti-depression medications prescribed.",{"measure":51,"description":52,"timeFrame":24},"National Health Interview Survey Adult Access to Health Care and Utilization Module","This protocol includes 10 interviewer-administered\n\nquestions from the National Health Interview\n\nSurvey (NHIS) Adult Access to Health Care \\&\n\nUtilization Module (CDC, 2019) designed to\n\nassess when medical care was last sought, usual\n\nplace of care, frequency of getting medical treatment.",{"measure":54,"description":55,"timeFrame":16},"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.",{"measure":57,"description":58,"timeFrame":24},"Number of Emergency Department Visits","Number of emergency department visits occurring during the specified period will be obtained from the electronic medical record.",{"measure":60,"description":61,"timeFrame":24},"Number of Participants Prescribed Opioid Medication","Number of participants with an opioid medication prescription documented in the electronic medical record during the specified period.",{"measure":63,"description":64,"timeFrame":24},"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.",{"measure":66,"description":67,"timeFrame":24},"Number of Participants Prescribed Antidepressant Medication","Number of participants with an antidepressant medication prescription documented in the electronic medical record during the specified period.",null,{"allocation":70,"interventionModel":71,"interventionModelDescription":72,"primaryPurpose":73,"observationalModel":68,"timePerspective":68,"maskingInfo":74},"NON_RANDOMIZED","SEQUENTIAL","This study uses a sequential, two-phase pre-post implementation design conducted at two Level I trauma centers. During the usual-care phase, 150 participants (75\u002Fsite) will receive each center's standard ACS guideline-adherent behavioral health screening, education, and referral services. Following implementation of TRRP 2.0, an additional 150 participants (75\u002Fsite) will receive TRRP services supported by the enhanced platform. Participants in both phases will complete baseline and 3-month assessments. Outcomes will be compared between the usual-care and TRRP 2.0 implementation phases to evaluate behavioral health service engagement and clinical outcomes.","TREATMENT",{"masking":75,"maskingDescription":68,"whoMasked":68},"NONE","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.",[78,84],{"label":79,"type":80,"description":81,"interventionNames":82},"Usual Care","ACTIVE_COMPARATOR","ACS adherent usual care for SBIRT and Behavioral Health Screening and Referral",[83],"Behavioral: Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0)",{"label":85,"type":86,"description":87,"interventionNames":88},"TRRP 2.0","EXPERIMENTAL","Service delivery via TRRP 2.0",[83],[90],{"type":91,"name":92,"description":93,"armGroupLabels":94,"otherNames":68},"BEHAVIORAL","Trauma 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\u002Fintervention resources and Epic electronic medical record read\u002Fwrite functionality.",[85,79],[96],{"name":97,"affiliation":5,"role":98},"Tatiana Davidson, PhD","PRINCIPAL_INVESTIGATOR",[100,104],{"name":97,"role":101,"phone":102,"phoneExt":68,"email":103},"CONTACT","8437920979","davidst@musc.edu",{"name":105,"role":101,"phone":102,"phoneExt":68,"email":106},"Sarah German, MA","germansa@musc.edu",{"type":98,"investigatorFullName":108,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":68,"oldOrganization":68},"Tatiana Davidson","Professor-Faculty","100656811","transforming-trauma-care-100656811",false,"NCT07829510","Transforming Trauma Care","Transforming Trauma Care: Innovative Solutions for Enhancing Behavioral Health Outcomes","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Admitted to a trauma center for ≥24 hours following injury\n* English- or Spanish-speaking\n\nExclusion Criteria:\n\n* Moderate to severe cognitive impairment\n* Active psychosis\n* Injury preventing verbal communication\n* Self-inflicted injury",true,"ALL","18 Years",{"count":121,"type":122},300,"ESTIMATED","INTERVENTIONAL",[125],"NA","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).\n\nThe 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.",[128,129,130,131],"Post-Traumatic Stress Disorder (PTSD)","Depression","Substance Use Disorder","Traumatic Injury",[133,134,128,129,135],"Trauma care","Behavioral health","Substance use","NOT_YET_RECRUITING","2026-09-14",{"date":139,"type":140},"2026-09-21","ACTUAL",{"date":142,"type":122},"2026-12-01",{"date":144,"type":122},"2028-08-30",{"name":5,"class":6}]