Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Posttraumatic Stress Disorder
- Sponsor
- Medical University of South Carolina
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- Change from Baseline PTSD Checklist for DSM-5 8- item (PCL8-5) at 3-,6-, and 12-month
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group.
Detailed Description
In 2015, our team launched the Trauma Resilience and Recovery Program (TRRP) at the Medical University of South Carolina's Level I trauma center. TRRP is a stepped model of care that is designed to deliver education at the bedside about mental health recovery after traumatic injury as well as risk assessment and brief intervention for high-risk patients (Step 1), foster symptom self-monitoring and continued education via our automated text messaging system (Step 2), screen for PTSD and depression by chatbot or telephone 30 days post-injury (Step 3), and provide a referral and warm handoff to mental health services if needed (Step 4). The purpose of the proposed study is to examine the clinical and functional impact of TRRP over a period of 12 months. We will conduct a randomized controlled trial (RCT) with one-year follow up of TRRP vs. enhanced usual care (EUC) with 350 patients at The George Washington University (GWU) hospital, which serves a diverse population of \~2000 trauma center patients per year (15% penetrating mechanism). Trained, supervised interviewers blind to study condition will assess clinical and functional outcomes 3-, 6-, and 12-months post-baseline (Aim 1). Qualitative interviews will be conducted with ≥ 30 patients from underrepresented minority groups (i.e., African American, Latinx) as well as ≥ 20 victims of violent trauma (penetrating mechanism) to identify opportunities to strengthen the model to meet the diverse needs of these patients (Aim 2). GWU does not currently have an embedded mental health program in place, which will enable us to explore implementation determinants systematically (Aim 3).
Investigators
Kenneth Ruggiero
Principal Investigator
Medical University of South Carolina
Eligibility Criteria
Inclusion Criteria
- •English- or Spanish-speaking patients ≥ 16 years old who are admitted to George Washington University hospital's trauma center and screen positive on the Injured Trauma Survivors Screen (which indicates risk for development of posttraumatic stress disorder and/or depression) will be included.
Exclusion Criteria
- •Patients who have a Glasgow Coma Scale score under 13 at hospital admission, moderate to severe cognitive impairment (as measured by the Montreal Cognitive Assessment), active psychosis, or injury that prevents verbal communication (e.g., serious head or spinal cord injury) or is self-inflicted will be excluded. Patients with positive substance use screens via GWU's SBIRT protocol (\~7% of the patient population) will be assessed by the clinical team with reference to severity and recency of substance use problems. We have found at MUSC that a high percentage of patients with SBIRT- positive screens are nevertheless good candidates for TRRP (\>85%), but patients with serious, active substance abuse problems are likely not good candidates for TRRP and therefore will be excluded and referred to a substance use treatment center.
Outcomes
Primary Outcomes
Change from Baseline PTSD Checklist for DSM-5 8- item (PCL8-5) at 3-,6-, and 12-month
Time Frame: Baseline, 3-, 6-, and 12- months 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. The PCL8-5 has strong psychometric properties and clinical utility data similar to that of the long version.
Secondary Outcomes
- Demographics(Baseline)
- Injured Trauma Survivor Screen (ITSS)(Baseline)
- Electronic Medical Record Data (EMR)(Baseline)
- The Kessler 6 (K6)(Baseline, 3-, 6-, and 12- months post-baseline)
- Patient Health Questionnaire-9 (PHQ-9)(3-, 6-, and 12-months post- baseline assessment)
- PROMIS Emotional and Instrumental Support(Baseline, 3-, 6-, and 12- months post-baseline)
- PROMIS Self-Efficacy(3-, 6-, and 12-months post- baseline assessment)
- PROMIS Global Health(3, 6, and 12-months post- baseline assessment)
- PROMIS Pain Intensity and Interference Scale(3-, 6-, and 12-months post- baseline assessment)
- PROMIS Sleep Disturbance(3, 6, and 12-months post- baseline assessment)
- National Health Interview Survey Barriers to Care(Baseline, 3-, 6-, and 12- months post-baseline)
- National Health Interview Survey Healthcare Utilization(Baseline and 12- months post-baseline)
- NHIS Mental Health Care Module(Baseline, 3-,6-, and 12-month post baseline)
- NHIS Job Status(Baseline, 3-,6-,and 12-month post baseline)
- The California Health Interview Survey (CHIS) question(Baseline, 3-, 6-, and 12- months post-baseline)
- CMH SDOH items(Baseline, 3-,6-,12-month post baseline)
- Collective Efficacy (Neighborhood Environment)(3-months post-baseline)
- Stigma Scale for Receiving Psychological Help(3-month post- baseline assessment)
- Discrimination in Medical Settings(3-month post baseline)
- National Adverse Childhood Experiences Questions(3-months post-baseline)
- NIDA Quick Screen (items 2-4); alcohol, tobacco, prescription and illicit drug use(3-, 6-, and 12-months post- baseline assessment)
- AUDIT-C(3-,6-,12-month post baseline)
- Acceptance of Treatment Referral and Initiation of Treatment(3-, 6-, and 12-months post- baseline assessment)