Recovery Legal Care Clinical Trial

NCT ID: NCT06618794

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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Firearm Injury Economic Problems Injury Traumatic Racism, Systemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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HVIP-MLP

This arm includes patients receiving usual care and also support from Recovery Legal Care (HVIP+MLP)

Group Type EXPERIMENTAL

Recovery Legal Care

Intervention Type OTHER

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.

HVIP Standard of Care

Intervention Type OTHER

These patients will receive HVIP standard of care (Violence Recovery Program Support)

HVIP

This arm includes patients receiving usual care (HVIP only).

Group Type ACTIVE_COMPARATOR

HVIP Standard of Care

Intervention Type OTHER

These patients will receive HVIP standard of care (Violence Recovery Program Support)

Interventions

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Recovery Legal Care

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.

Intervention Type OTHER

HVIP Standard of Care

These patients will receive HVIP standard of care (Violence Recovery Program Support)

Intervention Type OTHER

Other Intervention Names

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Civil Law Attorney Support Public Benefits Attorney Support Legal Aid Chicago Support HVIP - Violence Recovery Program

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

U.S. Department of Justice

FED

Sponsor Role collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role collaborator

University of Chicago

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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TANYA L ZAKRISON, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

ELIZABETH L TUNG, MD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Chicago

Locations

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University of Chicago Medical Center

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tanya L Zakrison, MD, MPH

Role: CONTACT

786-266-2228

Elizabeth L Tung, MD, MS

Role: CONTACT

773-702-6840

Facility Contacts

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Tanya L Zakrison, MD, MPH

Role: primary

786-266-2228

Elizabeth L Tung, MD, MS

Role: backup

773-702-6840

Related Links

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https://www.recoverylegal.uchicago.edu

Program/intervention website

Other Identifiers

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4UH3HD111325-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P50MD017349

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB24-0491

Identifier Type: -

Identifier Source: org_study_id

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