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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05497115
• Other study ID #: 20901
• Secondary ID: 1R01HS028006-01A
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: May 2024
• Source: Medical University of South Carolina
• Contact: Gabriela Becerra, BS
• Phone: 8439982602
• Email: becerra[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Wounds and Injuries

Intervention

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).

Locations

Country	Name	City	State
United States	George Washington University Hospital	Washington	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of South Carolina	Agency for Healthcare Research and Quality (AHRQ), George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	PROMIS Self-Efficacy	The 8-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
Secondary	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
Secondary	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
Secondary	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
Secondary	National Health Interview Survey Barriers to Care	This protocol includes 5 interviewer-administered questions from the National Health Interview Survey (NHIS) Barriers to Care 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
Secondary	National Health Interview Survey Healthcare Utilization	This protocol includes interviewer-administered questions from the National Health Interview Survey (NHIS) Healthcare Utilization 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 and 12- months post-baseline
Secondary	NHIS Mental Health Care Module	6 items is designed to assess when mental health care was last sough, usual place of care, frequency of getting mental health care and reasons for not getting mental health care.	Baseline, 3-,6-, and 12-month post baseline
Secondary	NHIS Job Status	Consistent with Zatzick and colleagues (2008) we will ask patients about post-injury occupational status.	Baseline, 3-,6-,and 12-month post baseline
Secondary	CMH SDOH items	The Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI) made the Accountable Health Communities (AHC) Health-Related Social Needs (HRSN) Screening Tool to use in the AHC Model.1 The test is to see if systematically finding and dealing with the health-related social needs of Medicare and Medicaid beneficiaries has any effect on their total health care costs and makes their health outcomes better.; The Tool can help providers find out patients' needs in these 5 core domains that community services can help with: Housing instability, food insecurity, transportation problems, Utility help needs and interpersonal safety.	Baseline, 3-,6-,12-month post baseline
Secondary	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
Secondary	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 4-point Likert scale.; Total Score Instructions: Total score of the 5 items. No Items are reverse scored.	3-month post- baseline assessment
Secondary	Discrimination in Medical Settings	The 7-item Discrimination in Medical Settings will measure perceived discrimination.	3-month post baseline
Secondary	Collective Efficacy (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
Secondary	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
Secondary	NIDA Quick Screen (items 2-4); 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
Secondary	AUDIT-C	The Alcohol Use Disorders Identification Test (AUDIT-C) is an alcohol screen that can help identify patients who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence).	3-,6-,12-month post baseline
Secondary	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