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CHW-Enhanced Trauma Recovery

Improving Engagement in Post-Injury Mental Health Care Through Community Health Worker-Enhanced Trauma Recovery Services

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07818161
Acronym
TRRP+
Enrollment
100
Registered
2026-09-14
Start date
2026-09-01
Completion date
2028-03-01
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Posttraumatic Stress Disorder, Social Determinants of Health, Traumatic Injury

Brief summary

This pilot study will evaluate the feasibility, acceptability, and preliminary effectiveness of the Trauma Resilience and Recovery Program Plus (TRRP+), a Community Health Worker-enhanced intervention designed to improve behavioral health engagement and recovery among adult trauma survivors with unmet social needs. One hundred adult trauma patients admitted to the Medical University of South Carolina Level I Adult Trauma Center who screen positive for risk of posttraumatic stress disorder (PTSD) or depression and report at least one unmet social need will receive TRRP+ services. Participants will complete assessments at baseline, 1 month, and 3 months after enrollment. The study will also examine implementation barriers and facilitators to support future dissemination and scale-up of the intervention.

Detailed description

Traumatic injuries are associated with substantial risk for posttraumatic stress disorder, depression, reduced quality of life, and poor recovery, particularly among survivors with unmet social determinants of health such as housing, food, financial, or transportation insecurity. The Trauma Resilience and Recovery Program (TRRP) is an evidence-based stepped-care model that includes in-hospital behavioral health education and screening, post-discharge symptom monitoring, 30-day follow-up screening, and referral to behavioral health treatment when indicated. TRRP+ enhances this model by integrating Community Health Worker (CHW)-delivered assessment, care planning, resource navigation, and follow-up support to address unmet social needs that may interfere with behavioral health engagement. Aim 1 will assess the feasibility, acceptability, and preliminary impact of TRRP+ in an open-label, single-arm pilot trial with 100 adult trauma survivors. Eligible participants will be adults admitted to the MUSC Level I Adult Trauma Center following traumatic injury who screen positive for risk of PTSD or depression on the Injured Trauma Survivor Screen and report at least one unmet social need on the Accountable Health Communities Health-Related Social Needs Screening Tool. Participants will receive TRRP+ and complete baseline, 1-month, and 3-month assessments of behavioral health service engagement, PTSD symptoms, depression symptoms, quality of life, social needs, substance use, and implementation outcomes. Aim 2 will use qualitative interviews and implementation evaluation activities guided by the Consolidated Framework for Implementation Research to identify barriers, facilitators, contextual factors, and implementation determinants that may affect adoption, scalability, and sustainability of TRRP+ within trauma care settings. Findings will inform refinement of the intervention and the design of a future multi-site hybrid effectiveness-implementation trial.

Interventions

BEHAVIORALCHW support

CHW support to address unmet SDOH needs.

Sponsors

Medical University of South Carolina
Lead SponsorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Adults 18 years of age or older. 2. Admitted to the Medical University of South Carolina (MUSC) Adult Trauma Service following a traumatic injury. 3. English-speaking. 4. Screen positive for risk of posttraumatic stress disorder (PTSD) and/or depression on the Injured Trauma Survivor Screen (ITSS), defined as a score greater than 2 on either subscale. 5. Report at least one unmet social need on the Accountable Health Communities (AHC) Health-Related Social Needs Screening Tool, defined as a score greater than or equal to 1. 6. Able and willing to provide informed consent.

Exclusion criteria

1. Glasgow Coma Scale (GCS) score less than 13 at hospital admission. 2. Moderate to severe cognitive impairment that precludes informed consent or study participation. 3. Active psychosis. 4. Injury that prevents verbal communication, such as severe traumatic brain injury or spinal cord injury. 5. Self-inflicted injury. 6. Currently incarcerated. 7. Unable to speak or understand English.

Design outcomes

Primary

MeasureTime frameDescription
DemographicsBaselinePatients will provide standard demographic information, such as race/ethnicity; sex; insurance, marital, and socioeconomic status; educational attainment; and occupation.
The Kessler 6 (K6)Baseline, 1 month and 3 monthsThe Kessler 6 (K6; Kessler et al., 2003) is a screening scale for nonspecific distress to discriminate cases of several mental illness. Items are rated on a 5-point Likert scale (1-5). Total scores range from 6-30 and are calculated as the sum of all item ratings, with a total score 13 indicating severe mental illness. This measure has been shown to have strong psychometric properties.
Injured Trauma Survivor Screen (ITSS)BaselineInjured Trauma Survivor Screen (ITSS; Hunt et al., 2018; 2018) 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 PTS 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.
Accountable Health Communities (AHC) Health-Related Social Needs Screening ToolBaseline and 3 monthThe AHC is a standardized 10-item instrument developed by the Centers for Medicare \& Medicaid Services (CMS) to identify individuals' social needs across five key domains: housing instability, food insecurity, transportation, utility needs, and interpersonal safety. The tool has demonstrated strong feasibility, reliability, and content validity (Billioux et al., 2017) across clinical settings and populations, supporting its widespread use for screening and referral within healthcare systems.
PTSD Checklist for DSM-5 (PCL-5)One month and 3 monthThe 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.
Patient Health Questionnaire (PHQ-8)one month and 3 monthThe Patient Health Questionnaire-8 (PHQ-8; Kroenke, Spitzer, \& Williams, 2001) assesses the presence and frequency of 8 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.
PROMIS General Life SatisfactionBaseline, one month, and 3 monthThe 10-item PROMIS General Life Satisfaction questionnaire (Salsman et al., 2014) measures one's perception of life experiences and whether one likes his/her life or not.
Service Engagement ScaleOne month and three monthThe 14-item measure that assesses the extent of a patient's engagement with mental health services across domains such as availability, collaboration, help-seeking, and medication adherence. The SES demonstrates strong psychometric properties (Tait et al., 2002), including high internal consistency (α ≈ .85-.90), good test-retest reliability, and established construct validity across clinical populations.
Intervention Acceptability3 monthA 4-item validated measure assessing the perceived acceptability of an intervention among those delivering or receiving it (Weiner et al., 2017). Strong psychometric properties and excellent internal consistency (Cronbach's α = 0.85-0.91).
Intervention Appropriateness3 monthA 4-item validated measure assessing the perceived fit, relevance, and suitability of an intervention for a particular setting or population. Strong psychometric properties and excellent internal consistency (Cronbach's α = 0.85-0.91)
Intervention Feasibility3 monthA 4-item validated measure assessing the extent to which an intervention is perceived as practical and implementable within a given setting. Strong psychometric properties and excellent internal consistency (Cronbach's α = 0.85-0.91).

Secondary

MeasureTime frameDescription
PROMIS Emotional and Instrumental SupportBaseline, one month, and three monthThe PROMIS Emotion and Instrumental Support (Hahn et al.,2014) 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.
National Health Interview Survey Adult Access to Health Care and Utilization ModuleBaseline, one month, and three monthThis protocol includes 10 interviewer-administered questions from the National Health Interview Survey (NHIS) Adult Access to Health Care \& Utilization Module (CDC, 2019) designed to assess when medical care was last sought, usual place of care, frequency of getting care and reasons for not getting care.
NIDA Quick Screen; alcohol, tobacco, prescription and illicit drug useBaseline, one month, and three monthThe NIDA Quick Screen (NIDA, 2010) 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

Countries

United States

Contacts

CONTACTSarah German
germansa@musc.edu8437920979
PRINCIPAL_INVESTIGATORTheresa Skojec, PhD

Medical University of South Carolina

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026