Transforming Trauma Care: Innovative Solutions for Enhancing Behavioral Health Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 主要终点
- Posttraumatic Stress Symptom Severity as Measured by the PCL-8
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥18 years
- •Admitted to a trauma center for ≥24 hours following injury
- •English- or Spanish-speaking
排除标准
- •Moderate to severe cognitive impairment
- •Active psychosis
- •Injury preventing verbal communication
- •Self-inflicted injury
研究组 & 干预措施
Usual Care
ACS adherent usual care for SBIRT and Behavioral Health Screening and Referral
干预措施: Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0) (Behavioral)
TRRP 2.0
Service delivery via TRRP 2.0
干预措施: Trauma Resilience and Recovery Program Portal 2.0 (TRRP 2.0) (Behavioral)
结局指标
主要结局
Posttraumatic Stress Symptom Severity as Measured by the PCL-8
时间窗: 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.
Number of Participants Screening Positive for Posttraumatic Stress Risk on the Injured Trauma Survivor Screen (ITSS)
时间窗: 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.
Change in Psychological Distress as Measured by the Kessler-6 (K6)
时间窗: 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.
Depressive Symptom Severity as Measured by the PHQ-8
时间窗: 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.
Frequency of Alcohol Use as Measured by the NIDA Quick Screen
时间窗: 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.
General Life Satisfaction as Measured by PROMIS General Life Satisfaction
时间窗: 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.
Frequency of Tobacco Use as Measured by the NIDA Quick Screen
时间窗: 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.
Frequency of Prescription Drug Use for Nonmedical Reasons as Measured by the NIDA Quick Screen
时间窗: 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.
Frequency of Illegal Drug Use as Measured by the NIDA Quick Screen
时间窗: 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.
Number of Participants Screening Positive for Depression Risk on the Injured Trauma Survivor Screen (ITSS)
时间窗: 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.
次要结局
- Hospital Length of Stay(Baseline)
- Electronic Medical Record Data(Baseline)
- National Health Interview Survey Adult Access to Health Care and Utilization Module(3 months postbaseline)
- Injury Severity Score (ISS)(Baseline)
- Number of Emergency Department Visits(3 months postbaseline)
- Number of Participants Prescribed Opioid Medication(3 months postbaseline)
- Number of Participants Prescribed Anti-Anxiety Medication(3 months postbaseline)
- Number of Participants Prescribed Antidepressant Medication(3 months postbaseline)
研究者
Tatiana Davidson
Professor-Faculty
Medical University of South Carolina