Clinical trial NCT05497115: Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury
Official title: Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Depression
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: George Washington University
name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2022-08-11
Enrollment: 350
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Change from Baseline PTSD Checklist for DSM-5 8- item (PCL8-5) at 3-,6-, and 12-month
timeFrame: Baseline, 3-, 6-, and 12- months post-baseline
Secondary outcomes:
measure: Demographics
timeFrame: Baseline
measure: Injured Trauma Survivor Screen (ITSS)
timeFrame: Baseline
measure: Electronic Medical Record Data (EMR)
timeFrame: Baseline
measure: The Kessler 6 (K6)
timeFrame: Baseline, 3-, 6-, and 12- months post-baseline
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 3-, 6-, and 12-months post- baseline assessment
measure: PROMIS Emotional and Instrumental Support
timeFrame: Baseline, 3-, 6-, and 12- months post-baseline
measure: PROMIS Self-Efficacy
timeFrame: 3-, 6-, and 12-months post- baseline assessment
measure: PROMIS Global Health
timeFrame: 3, 6, and 12-months post- baseline assessment
measure: PROMIS Pain Intensity and Interference Scale
timeFrame: 3-, 6-, and 12-months post- baseline assessment
measure: PROMIS Sleep Disturbance
timeFrame: 3, 6, and 12-months post- baseline assessment
measure: National Health Interview Survey Barriers to Care
timeFrame: Baseline, 3-, 6-, and 12- months post-baseline
measure: National Health Interview Survey Healthcare Utilization
timeFrame: Baseline and 12- months post-baseline
measure: NHIS Mental Health Care Module
timeFrame: Baseline, 3-,6-, and 12-month post baseline
measure: NHIS Job Status
timeFrame: Baseline, 3-,6-,and 12-month post baseline
measure: CMH SDOH items
timeFrame: Baseline, 3-,6-,12-month post baseline
measure: The California Health Interview Survey (CHIS) question
timeFrame: Baseline, 3-, 6-, and 12- months post-baseline
measure: Stigma Scale for Receiving Psychological Help
timeFrame: 3-month post- baseline assessment
measure: Discrimination in Medical Settings
timeFrame: 3-month post baseline
measure: Collective Efficacy (Neighborhood Environment)
timeFrame: 3-months post-baseline
measure: National Adverse Childhood Experiences Questions
timeFrame: 3-months post-baseline
measure: NIDA Quick Screen (items 2-4); alcohol, tobacco, prescription and illicit drug use
timeFrame: 3-, 6-, and 12-months post- baseline assessment
measure: AUDIT-C
timeFrame: 3-,6-,12-month post baseline
measure: Acceptance of Treatment Referral and Initiation of Treatment
timeFrame: 3-, 6-, and 12-months post- baseline assessment
Other outcomes:
Locations:
city: Washington
country: United States
facility: George Washington University Hospital
state: Virginia
Study officials:
affiliation: Medical University of South Carolina
name: Kenneth Ruggiero, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Espeleta HC, Witcraft SM, Raffa T, Kartiko S, Dawson D, Becerra G, Roisman H, Hughes-Halbert C, Mueller M, Powell E, Brock T, Sarani B, Ruggiero KJ. Hybrid 1 randomized controlled trial of an integrated stepped-care mental health intervention for traumatic injury patients. Contemp Clin Trials. 2024 Nov;146:107694. doi: 10.1016/j.cct.2024.107694. Epub 2024 Sep 17.