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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Posttraumatic Stress Disorder, Depression

Intervention / Treatment
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* Behavioral: Trauma Resilience and Recovery Program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trauma Resilience and Recovery Program<br>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) | Behavioral: Trauma Resilience and Recovery Program<br>* 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).<br>|
| No Intervention: Enhanced Usual Care Condition<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline PTSD Checklist for DSM-5 8- item (PCL8-5) at 3-,6-, and 12-month | 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. | Baseline, 3-, 6-, and 12- months post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographics | Patients will provide standard demographic information, such as race/ethnicity; sex; gender identity; immigration, insurance, marital, and socioeconomic status; language; educational attainment; and occupation | Baseline | 
| Injured Trauma Survivor Screen (ITSS) | Injured Trauma Survivor Screen (ITSS) is a 9-item measure used to assess risk for development of posttraumatic stress symptoms following injury. Items are rated yes=1 and no=0. If the sum of questions 1, 2, 3, 5, and 6 is equal to or greater than 2, the screen is positive for PTSD risk. If the sum of questions 3, 4, 7, 8, and 9 is equal or greater than 2, the screen is positive for depression risk. | Baseline | 
| Electronic Medical Record Data (EMR) | Data will be collected at baseline via the electronic medical record including patients' length of stay; injury severity scores; number of emergency department visits; and opioid, anti-anxiety and anti-depression medications prescribed. | Baseline | 
| The Kessler 6 (K6) | The Kessler 6 (K6) is a screening scale for nonspecific distress to discriminate cases of severe mental illness. Items are rated on a 5-point Likert scale (0-4). Total scores range from 0-24 and are calculated as the sum of all item ratings, with a total score ≥ 5 indicating moderate levels of distress and scores ≥ 13 indicating severe mental illness. This measure has been shown to have strong psychometric properties. | Baseline, 3-, 6-, and 12- months post-baseline | 
| PROMIS Emotional and Instrumental Support | The PROMIS Emotion and Instrumental Support measure assesses perceived feelings of being cared for and valued as a person; having confidant relationships and availability of assistance with material, cognitive, or task performance. Calculate a summed score across all items. All item responses scored on a scale of 1-5 where Never = 1, Always = 5 3. Score of a 50 is the average for US population, SD of 10 | Baseline, 3-, 6-, and 12- months post-baseline | 
| The Major Experiences and Everyday Discrimination Scale | The Major Experiences and Everyday Discrimination Scales include 19 yes-or-no and frequency response category questions. The Major Experiences subscale includes 9 questions about employment, housing, and education; the Everyday Discrimination subscale includes 10 questions about interactions with other people, including courtesy, respect, and harassment. * no scoring needed at this time. | Baseline, 3-, 6-, and 12- months post-baseline | 
| National Health Interview Survey Adult Access to Health Care and Utilization Module | This protocol includes 10 interviewer-administered questions from the National Health Interview Survey (NHIS) Adult Access to Health Care & Utilization Module designed to assess when medical care was last sought, usual place of care, frequency of getting medical care and reasons for not getting medical care. | Baseline, 3-, 6-, and 12- months post-baseline | 
| The California Health Interview Survey (CHIS) question | The California Health Interview Survey (CHIS) question allows a binary measurement of perceived prejudice, stereotyping, and discrimination in clinical encounters and experience. | Baseline, 3-, 6-, and 12- months post-baseline | 
| Patient Health Questionnaire-9 (PHQ-9) | The Patient Health Questionniare-9 (PHQ-9) assesses the presence and frequency of 9 core depressive symptoms. Items are rated on a 4-point Likert scale (0-3). Total scores range from 0-27 and are calculated as the sum of all item ratings, with a total score of ≥ 10 indicating clinical significance. | 3-, 6-, and 12-months post- baseline assessment | 
| Acceptance of Treatment Referral and Initiation of Treatment | Patients will be asked whether they considered seeking assistance for mental health needs and whether they actually sought help. These questions will be based on semi-structured interviews administered via our needs assessment that were adapted from epidemiologic interviews conducted by our team in the aftermath of the September 11, 2001 terrorist attacks and recent natural disasters. Follow-up questions will inquire about whether patients sought help from family members, friends, chaplains, mental health professionals, or other health care professionals. | 3-, 6-, and 12-months post- baseline assessment | 
| PROMIS Pain Intensity and Interference Scale | The PROMIS Pain Intensity and Interference scale assesses patients' pain and the extent to which it affects enjoyment of various activities in the past 7 days. Calculate a summed score access all items. All item responses scored on a scale of 1-5 where Never=1, Always = 5 Score of a 50 is the average for US population, SD of 10. | 3-, 6-, and 12-months post- baseline assessment | 
| Stigma Scale for Receiving Psychological Help | The Stigma Scale for Receiving Psychological Help assesses individuals' perceptions of how stigmatizing it is to receive psychological treatment. The SSRPH consists of 5 questions rated on a 3-point Likert scale. Total Score Instructions: Total score of the 5 items. No Items are reverse scored. | 3-, 6-, and 12-months post- baseline assessment | 
| NIDA Quick Screen; alcohol, tobacco, prescription and illicit drug use | The NIDA Quick Screen is a validated instrument designed to assist providers in screening adults for substance use. The screen simply inquires whether a participant has used drugs (mood-altering, illegal, or prescription for nonmedical reasons), alcohol, or tobacco products within the past year and how often these substances have been used. | 3-, 6-, and 12-months post- baseline assessment | 
| PROMIS Self-Efficacy | The 4-item PROMIS Self-Efficacy scale is a measure of confidence in one's ability to deal effectively with a variety of stressful situations. Calculate a summed score access all items. All item responses scored on a scale of 1-5 where Never=1, Always = 5 Score of a 50 is the average for US population, SD of 10. | 3-, 6-, and 12-months post- baseline assessment | 
| PROMIS Sleep Disturbance | The 4-item PROMIS Sleep Disturbance scale assesses perceptions of sleep quality, sleep depth, and restoration associated with sleep. Calculate a summed score access all items. All item responses scored on a scale of 1-5. Score of a 50 is the average for US population, SD of 10. | 3, 6, and 12-months post- baseline assessment | 
| PROMIS General Life Satisfaction | The 10-item PROMIS General Life Satisfaction questionnaire measures one's perception of life experiences and whether one likes his/her life or not. Calculate a summed score access all items. All item responses scored on a scale of 1-5 where Never=1, Always = 5 Score of a 50 is the average for US population, SD of 10. | 3, 6, and 12-months post- baseline assessment | 
| PROMIS Global Health | The 10-item PROMIS Global Health questionnaire measures one's overall evaluation of one's physical and mental health. | 3, 6, and 12-months post- baseline assessment | 
| Occupational Status | Consistent with Zatzick and colleagues we will ask patients about post-injury occupational status. | 3, 6, and 12-months post- baseline assessment | 
| Job Insecurity | The Job Insecurity measure is a measurement of the perceived stability of one's current job and ability to find jobs with similar salary and benefits. | 3, 6, and 12-months post- baseline assessment | 
| Food Insecurity | The six-item standard measure from the U.S. Department of Agriculture Economic Research Service is a validated, well-established measure of the availability, accessibility, and affordability of nutritionally adequate food. | 3, 6, and 12-months post- baseline assessment | 
| National Adverse Childhood Experiences Questions | The six-item standard measure from the U.S. Department of Agriculture Economic Research Service is a validated, well-established measure of the availability, accessibility, and affordability of nutritionally adequate food. | 3-months post-baseline | 
| Neighborhood Environment | The Neighborhood Environment Scale measures perceived neighborhood context and provides an estimate of cumulative exposure to adversity in childhood. | 3-months post-baseline |