Recovery Legal Care Clinical Trial
HVIP-MLP
3 other identifiers
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2024
CompletedFirst Posted
Study publicly available on registry
October 1, 2024
CompletedStudy Start
First participant enrolled
February 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
July 3, 2025
July 1, 2025
1.6 years
March 6, 2024
July 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Firearm victimization and aggression
The adapted Conflict Tactics Scale 2 (CTS2) measures behaviors related to firearm victimization and aggression over the past 3 months.
Baseline, 3 months, 6 months, 12 months, 18 months
Secondary Outcomes (4)
Legal needs self-efficacy
Baseline, 3 months, 6 months, 12 months, 18 months
Health-related quality of life
Baseline, 3 months, 6 months, 12 months, 18 months
Post-Traumatic Stress Disorder (PTSD) Symptoms
Baseline, 3 months, 6 months, 12 months, 18 months
Stress
Baseline, 3 months, 6 months, 12 months, 18 months
Study Arms (2)
HVIP-MLP
EXPERIMENTALThis arm includes patients receiving usual care and also support from Recovery Legal Care (HVIP+MLP)
HVIP
ACTIVE COMPARATORThis arm includes patients receiving usual care (HVIP only).
Interventions
These patients will receive support from our HVIP standard of care (Violence Recovery Program) plus our Medical Legal Partnership (Recovery Legal Care) for additional legal support to address health-harming legal needs and public benefits.
These patients will receive HVIP standard of care (Violence Recovery Program Support)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
TANYA L ZAKRISON, MD, MPH
University of Chicago
- PRINCIPAL INVESTIGATOR
ELIZABETH L TUNG, MD, MS
University of Chicago
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2024
First Posted
October 1, 2024
Study Start
February 10, 2025
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2027
Last Updated
July 3, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- IPD and supporting information will be available at the conclusion of data collection (11/1/2026) and will last for 5 years (10/31/2031).
- Access Criteria
- Data will be shared with trained and credentialed analysts from the CFVP team. They will be able to access de-identified survey data through an encrypted portal.
Data from this project will be shared with the Community Firearm Violence Prevention (CFVP) Network at the University of Michigan as part of a data sharing agreement stipulated under the UG3/UH3 award funding this research.