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NCT Number: NCT06618794

Recovery Legal Care Clinical Trial

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 perceived stress, violence-related outcomes, legal needs, health-related quality of life, and PTSD symptoms.

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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 perceived stress. As secondary objectives, it will also evaluate whether the HVIP-MLP model can improve violence-related outcomes, health-related quality of life, and PTSD symptoms 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Treatment for an interpersonal violent injury at the University of Chicago Trauma Center (e.g., gunshot, stab wound, assault)
  • Ages 14+ 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 (e.g., psychotic disorder, schizophrenia, suicidality)
  • Treated for a non-interpersonal violent injury type (e.g., car accident)
  • Treated for self-inflicted or accidental injuries
  • 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 a non-Illinois address
  • Non-English speakers

Treatment and study plan

Recovery Legal Care

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.

Other names: Civil Law Attorney Support, Public Benefits Attorney Support, Legal Aid Chicago Support

HVIP Standard of Care

Other

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

Other names: HVIP - Violence Recovery Program

Primary outcomes

  1. Stress

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months

    The Patient-Reported Outcomes Measurement Information System (PROMIS) scale measures self-reported psychological stress.

Secondary outcomes

  1. Firearm victimization and aggression

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months

    The adapted Conflict Tactics Scale 2 (CTS2) measures behaviors related to firearm victimization and aggression over the past 3 months.

  2. Legal needs self-efficacy

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months

    The adapted Bandura Self-Efficacy Scale measures belief in one's ability to have legal needs addressed.

  3. Health-related quality of life

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months

    The SF-12 Health Survey measures both physical and mental health domains of health-related quality of life.

  4. Post-Traumatic Stress Disorder (PTSD) Symptoms

    Time frame: Baseline, 3 months, 6 months, 12 months, 18 months

    The PCL-5 measures symptoms of PTSD.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth L Tung, MD, MS

CONTACT

[email protected]

773-702-6840

Tanya L Zakrison, MD, MPH

CONTACT

[email protected]

786-266-2228

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Minority Health and Health Disparities (NIMHD)
  • U.S. Department of Justice

Registry information

Acronym: HVIP-MLP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 1, 2024
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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