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

Medical University of South Carolina (MUSC)

Status: Enrolling

Conditions: Posttraumatic Stress Disorder; Depression

Treatments: Behavioral: Trauma Resilience and Recovery Program

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05497115

20901

1R01HS028006-01A1 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

The purpose of this study to learn about patients' experience with the Trauma Resilience and Recovery program (TRRP) and/or the enhanced care group.

Full 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).

Enrollment: 350 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups

Trauma Resilience and Recovery Program

Experimental group

Description:

TRRP is a stepped model of care that delivers 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), fosters symptom monitoring and continued education (Step 2), screens for PTSD and depression 30 days post-injury (Step 3), and provides a referral and warm handoff to mental health services if needed (Step 4)

Treatment:

Behavioral: Trauma Resilience and Recovery Program

Enhanced Usual Care Condition

No Intervention group

Description:

Patients in the EUC arm will be given education about mental health after traumatic injury, educational materials about mental health recovery, and local referral information to assist treatment-seeking patients in seeking care.