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

Обзор

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

Подробное описание

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).

Вмешательства

• Поведенческое 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).

Первичные конечные точки

• Change from Baseline PTSD Checklist for DSM-5 8- item (PCL8-5) at 3-,6-, and 12-month [Срок оценки: Baseline, 3-, 6-, and 12- months post-baseline]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• George Washington University Hospital — Washington

Публикации

• 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

Идентификаторы

NCT: NCT05497115 · 20901 · 1R01HS028006-01A1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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