Testing a Scalable Model of Care to Improve Patients Access to Mental Health Services After Traumatic Injury

Overview

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).

Interventions

• Behavioral Trauma Resilience and Recovery Program
  The Trauma Resilience and Recovery Program 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 (Step 2), screen for PTSD and depression 30 days post-injury (Step 3), and provide a referral and warm handoff to mental health services if needed (Step 4).

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Demographics [Time frame: Baseline]
• Injured Trauma Survivor Screen (ITSS) [Time frame: Baseline]
• Electronic Medical Record Data (EMR) [Time frame: Baseline]
• The Kessler 6 (K6) [Time frame: Baseline, 3-, 6-, and 12- months post-baseline]
• Patient Health Questionnaire-9 (PHQ-9) [Time frame: 3-, 6-, and 12-months post- baseline assessment]
• PROMIS Emotional and Instrumental Support [Time frame: Baseline, 3-, 6-, and 12- months post-baseline]
• PROMIS Self-Efficacy [Time frame: 3-, 6-, and 12-months post- baseline assessment]
• PROMIS Global Health [Time frame: 3, 6, and 12-months post- baseline assessment]
• PROMIS Pain Intensity and Interference Scale [Time frame: 3-, 6-, and 12-months post- baseline assessment]
• PROMIS Sleep Disturbance [Time frame: 3, 6, and 12-months post- baseline assessment]
• National Health Interview Survey Barriers to Care [Time frame: Baseline, 3-, 6-, and 12- months post-baseline]
• National Health Interview Survey Healthcare Utilization [Time frame: Baseline and 12- months post-baseline]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• George Washington University Hospital — Washington

Publications

• 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. PMID 39299544

Identifiers

NCT: NCT05497115 · 20901 · 1R01HS028006-01A1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗