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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HS028006-01A1 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| George Washington University | OTHER |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trauma Resilience and Recovery Program | Experimental | 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) |
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| Enhanced Usual Care Condition | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trauma Resilience and Recovery Program | Behavioral | 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). |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Becerra, BS | Contact | 8439982602 | becerra@musc.edu | |
| Hannah Espeleta, PhD | Contact | 84377957658 | espeleta@musc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Ruggiero, PhD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University Hospital | Recruiting | Washington | Virginia | 20037 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39299544 | Background | 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. |
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First, we will analyze the qualitative and quantitative data from our interviews and randomized controlled trial and will share these data via The National Database for Clinical Trials Related to Mental Illness. We will prepare both brief and comprehensive reports for AHRQ as we have done in prior NIH studies. We also will disseminate reports of our findings via print copy to the MUSC and GWU Public Relations office and websites. Additionally, we will prepare manuscripts for submission to research journals, such as JAMA, JAMA Surgery, JAMA Psychiatry, Am J Psychiatry, J Trauma and Acute Care Surgery, J Am College of Surgeons, Am J Public Health, and other sources that ensure broad dissemination. Additionally, as we have done previously with other federally funded grants, we will seek to present our findings to AHRQ staff and at national and international conferences.
Data will become available Year 3 quarter 3 of the study
REDCap data dictionaries can be distributed for reuse at multiple institutions. A library of data dictionaries is made available for standards-based data collection forms and validated instruments. The underlying database is hosted in a secure data center at MUSC, a secure environment for data systems and servers on campus, and includes redundancy, failover capability, backups and extensive security checks.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 14, 2024 | May 17, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003863 | Depression |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
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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 |
| 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 |
| 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.
| Baseline, 3-, 6-, and 12- months post-baseline |
| 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.
| 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 |
| 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.
| 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.
| 3, 6, and 12-months post- baseline assessment |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Discrimination in Medical Settings | The 7-item Discrimination in Medical Settings will measure perceived discrimination. | 3-month post baseline |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| D001519 | Behavior |