Clinical trial NCT06618794: Recovery Legal Care Clinical Trial
Official title: Recovery Legal Care Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Firearm Injury
Economic Problems
Injury Traumatic
Racism, Systemic
Keywords: Firearm injury
Community violence
Medical-Legal Partnership
Systemic racism
Structural violence
Civil law attorneys
Health-Harming Legal Needs
Hospital-Based Violence Intervention Program
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: U.S. Department of Justice
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-10-01
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 64
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Hospital-Based Violence Intervention Programs (HVIPs) affiliated with trauma centers in the US often focus on individual behavior modification for reduction in re-victimization. There is a lack of reproducible evidence that has demonstrated effectiveness, given the exclusion of addressing inequities in the Social and Structural Determinants of Health (SSDOH), often the root causes of violent injury and preventable homicide. The study investigators created a Medical Legal Partnership (MLP) to partner with an existing HVIP. This novel program offers beside legal assistance to address the SSDOH. The purpose of this study is to evaluate the effectiveness of the HVIP-MLP program in improving violence-related outcomes, legal needs, health-related quality of life, PTSD symptoms, and perceived stress.

Detailed description: National trauma center verification relies on a commitment to injury prevention efforts, including prevention of community-level violence. Hospital-Based Violence Recovery Programs (HVIPs) have expanded across the country as extensions of level I and II trauma centers to address trauma recidivism with individual behavioral modification during the "teachable moment." There is little evidence that has demonstrated consistent effectiveness of this approach. One possible reason is the difficulty for community-based violence prevention specialists from HVIP programs to address the larger inequities in the Structural and Social Determinants of Health (SSDOH) that lead to violence through. Medical-Legal Partnership is one approach that has demonstrated evidence and success in improving health outcomes and reducing health-harming legal needs of patients, by connecting legal experts to medical experts for holistic care. This has yet to be done for trauma patients and has, to our knowledge, not been incorporated into any HVIP approach thus far. This clinical trial will evaluate the effectiveness of the HVIP-MLP model to address legal needs rooted in the SSDOH and improve violence-related outcomes. As secondary objectives, it will also evaluate whether the HVIP-MLP model can improve health-related quality of life, PTSD symptoms, and perceived stress among study participants. This novel HVIP-MLP approach has the potential to broadly impact the HVIP model to include an MLP component to all trauma centers for verification to support patients, families and providers alike in this important public health work.

Eligibility criteria: Inclusion Criteria:

* Treatment for a violent injury at the University of Chicago Trauma Center
* Ages 14-64 years
* Able to provide informed consent (18 years and older) or assent (14-17 years)

Inclusion of women and minorities: This research proposal includes women and ethnic minorities. Patient participants will be primarily non-Hispanic Black or Hispanic race and ethnicity. The study expects participants to be proportional to the population-wide estimates for the South Side community. The majority will be low-income with variable functional health literacy. These characteristics are representative of the target population and describe the population most likely to benefit from the proposed study. Youth stakeholder participants will be multi-ethnic and racially diverse.

Inclusion of children: This study will include children ages 14-17 years old, based on Illinois state labor laws for child employment, as well as the ages of youth who are primarily treated for penetrating injury at the UCMC trauma center. This age is also a pragmatic cutoff for children providing meaningful input on community and healthcare solutions to violence.

Exclusion Criteria:

* Diagnosis of severe mental illness (i.e., psychotic disorder, schizophrenia, suicidality)
* Unable to provide informed consent due to mental status
* Prior receipt of legal services at UCMC within the past year
* Currently imprisoned or incarcerated
* Residing at an Indiana address.

Primary outcomes:
measure: Firearm victimization and aggression
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
Secondary outcomes:
measure: Legal needs self-efficacy
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Health-related quality of life
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Post-Traumatic Stress Disorder (PTSD) Symptoms
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
measure: Stress
timeFrame: Baseline, 3 months, 6 months, 12 months, 18 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: TANYA L ZAKRISON, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Chicago
name: ELIZABETH L TUNG, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: