Recovery Legal Care for Traumatic Injury

(HVIP-MLP Trial)

Overseen By Elizabeth L Tung, MD, MS

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Disqualifiers: Severe mental illness, Incarceration, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called Recovery Legal Care, which combines hospital care with legal support to assist individuals injured in violent incidents. The researchers aim to determine if this approach can improve outcomes such as quality of life, PTSD symptoms, and stress by addressing deeper social and legal issues. Participants will receive either standard hospital care or enhanced care with legal support. This trial suits individuals treated for violent injuries at the University of Chicago Trauma Center who have not received legal help there in the past year and are not currently in prison. As an unphased trial, it offers a unique opportunity to explore innovative care that could significantly enhance recovery and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this program is safe?

Research has shown that Recovery Legal Care, part of a Medical Legal Partnership (MLP), meets the social and economic needs of individuals who have experienced violence. It provides legal assistance at the bedside to improve housing and job opportunities. This approach addresses the root causes of violence, such as social and structural issues. Although this concept is new and lacks direct safety data, it does not involve new medications or risky procedures. Instead, it focuses on legal support to enhance life situations. A large NIH grant backs this model, indicating confidence in its potential benefits and safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Recovery Legal Care for traumatic injuries because it combines medical and legal support to address the broader impacts of injury. Unlike standard treatments that focus solely on physical healing, this approach integrates legal assistance to tackle social and legal challenges that can hinder recovery. By addressing these often-overlooked aspects, Recovery Legal Care aims to enhance the healing process and improve overall patient outcomes.

What evidence suggests that the HVIP-MLP program is effective for improving violence-related outcomes?

Research has shown that Medical-Legal Partnerships (MLPs), which participants in this trial may receive as part of the HVIP-MLP arm, can greatly assist patients recovering from violent injuries. These partnerships offer legal help with important issues like housing, food access, and jobs, which are crucial for recovery. Studies have found that MLPs can improve these social and economic conditions, helping to break the cycle of violence. This approach has led to fewer injuries related to violence and lower rates of returning to harmful behaviors. Additionally, people in these programs often experience improved mental and emotional well-being. ^{2 3 5 6 7}

Who Is on the Research Team?

TANYA L ZAKRISON, MD, MPH

Principal Investigator

University of Chicago

ELIZABETH L TUNG, MD, MS

Principal Investigator

University of Chicago

Are You a Good Fit for This Trial?

This trial is for individuals who have experienced a traumatic injury, such as a gunshot wound, and are facing financial difficulties or systemic racism. To join, they must be part of an HVIP program at a US trauma center.

Inclusion Criteria

Treatment for a violent injury at the University of Chicago Trauma Center

I am 18 or older and can give my consent, or I am 14-17 and can give my assent.

I am a child aged 14-17.

Exclusion Criteria

Currently imprisoned or incarcerated

Residing at an Indiana address

Diagnosis of severe mental illness (i.e., psychotic disorder, schizophrenia, suicidality)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive support from Recovery Legal Care (HVIP+MLP) or usual care (HVIP only) to address legal needs and improve violence-related outcomes

18 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on violence-related outcomes, PTSD symptoms, stress, and health-related quality of life

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Recovery Legal Care

Trial Overview The study tests the effectiveness of adding Recovery Legal Care to standard HVIP care. This new approach provides legal assistance at the bedside to address social and structural issues contributing to violent injuries.

How Is the Trial Designed?

Group I: HVIP-MLP Experimental Treatment 2 Interventions

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

Group II: HVIP Active Control 1 Intervention

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

Recovery Legal Care is already approved in United States for the following indications:

Approved in United States as Recovery Legal Care for:

• Violence-related outcomes
• Legal needs
• Health-related quality of life
• PTSD symptoms
• Perceived stress

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

U.S. Department of Justice

Collaborator

Trials

23

Recruited

86,700+

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

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

The study analyzed electronic health records of patients with violent trauma at a level 1 trauma center, revealing that assault injuries were the most common cause, particularly among black males with an average age of 33.

The findings suggest that Hospital Violence Intervention Programs (HVIPs) are essential for providing comprehensive care and standardized follow-up for patients, as nearly 80% of cases lacked documentation on the assailant's relationship, indicating a need for better risk assessment and management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of Adult Patients for Violence-Related Injuries Presenting to a Level 1 Trauma Center in Midwest United States. Hiranniramol, K., Moran, V., Israel, H., et al.[2023]

Communication-and-resolution programs (CRPs) aim to improve patient safety by promptly identifying medical injuries, ensuring compassionate disclosure to patients, and facilitating timely resolutions, including apologies and compensation.

Successful implementation of CRPs could be enhanced by supportive legal policies that reduce fears of litigation for healthcare providers, encourage patient participation, and clarify reporting practices related to medical errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How policy makers can smooth the way for communication-and- resolution programs. Sage, WM., Gallagher, TH., Armstrong, S., et al.[2014]

The study found a low long-term violent-injury recidivism rate of 4.4% among 328 participants in the Prescription for Hope (RxH) hospital-based violence intervention program over an 8-year period, indicating that the program has lasting positive effects on most participants.

Despite the low recidivism rate, many patients still visited the emergency department for non-violent issues, suggesting that HVIPs could enhance their impact by collaborating with organizations focused on preventing substance abuse, suicide, and unintentional injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term evaluation of a hospital-based violence intervention program using a regional health information exchange. Bell, TM., Gilyan, D., Moore, BA., et al.[2019]

Out of 2,243 violently injured patients, 839 (37.4%) engaged with the Boston Violence Intervention Advocacy Program (VIAP), with younger age, Black race, and more severe injuries being significant predictors of engagement.

Clients who engaged with VIAP faced challenges in achieving goals related to education, employment, and housing, indicating that while the program is effective in reaching its target population, there is a need for tailored strategies to address these complex needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Boston Violence Intervention Advocacy Program: Challenges and Opportunities for Client Engagement and Goal Achievement. Pino, EC., Fontin, F., James, TL., et al.[2021]

The home visiting nurse pilot program, part of a hospital-based violence intervention program, targeted 57 patients with severe gunshot wounds, showing a low rehospitalization rate of only 3.5% within 90 days, indicating potential effectiveness in post-injury care.

Key interventions included medical navigation, education, and wound care, highlighting the importance of improving health literacy and access to care for survivors of violent injuries, which can help reduce health disparities in this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a Novel Home Visiting Nurse Pilot Program for Victims of Violent Penetrating Injury. Pino, EC., Fontin, F., Dugan, E.[2023]

A systematic review of 10 studies on hospital-based violent injury prevention programs (HVIPs) for adults found insufficient evidence to support their effectiveness in preventing violent reinjury, arrest, or substance abuse.

The review highlighted limitations such as small sample sizes and self-selection bias in the available studies, leading to no recommendations for adult-focused HVIPs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hospital-based violence intervention programs targeting adult populations: an Eastern Association for the Surgery of Trauma evidence-based review. Affinati, S., Patton, D., Hansen, L., et al.[2022]

Adverse events in healthcare affect three groups: patients and families (first victims), healthcare professionals (second victims), and healthcare organizations (third victims), highlighting the need for comprehensive support for all involved.

The review of 25 studies emphasizes the importance of communication, support, and systematic action following adverse events, indicating a significant gap in comprehensive models for managing these incidents effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Action after Adverse Events in Healthcare: An Integrative Literature Review. Liukka, M., Steven, A., Moreno, MFV., et al.[2020]

A nationwide survey of 32 hospital-based violence intervention programs revealed that only 39% of representatives were aware of existing hospital policies regarding law enforcement interactions, indicating a significant gap in knowledge that could affect patient care.

Most respondents felt that current policies were inadequate and potentially biased, highlighting the need for clearer guidelines, better education for both healthcare staff and law enforcement, and improved communication to protect the rights and health of violently injured patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Law Enforcement and Patient Privacy Among Survivors of Violence: A Nationwide Mixed-Methods Study. Gallen, KM., Smith, MJ., Crane, J., et al.[2023]

In a study of 295 patients involved in a hospital-based violence intervention program (HVIP), nearly 50% achieved their personal health and social goals within 6 months, indicating the program's effectiveness in addressing immediate needs after injury.

HVIP participants showed significantly lower levels of PTSD and higher positive emotional states at discharge compared to non-HVIP patients, suggesting that engagement in the program leads to better short-term health outcomes and improved social determinants of health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beyond Recidivism: Hospital-Based Violence Intervention and Early Health and Social Outcomes. Gorman, E., Coles, Z., Baker, N., et al.[2022]

Citations

1. chronicdisease.uchicago.edu chronicdisease.uchicago.edu/2025/10/26/study-shows-medical-legal-partnerships-aid-recovery-for-patients-with-violent-injuries/

Study Shows Medical-Legal Partnerships Aid Recovery for ... Through this financial return, the program aims to disrupt cycles of violence by stabilizing housing, food access, and employment. “When ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06618794?aggFilters=funderType:nih,status:rec%20not%20ava&cond=trauma&rank=10

Recovery Legal Care Clinical Trial (HVIP-MLP) 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12531874/

Income Support Needs and Bedside Legal Assistance for ... Recovery Legal Care is an MLP that offers bedside legal assistance to support the social and economic needs of survivors of violence. Despite ...

4. withpower.com withpower.com/trial/phase-traumatic-injuries-10-2024-13a87

Recovery Legal Care for Traumatic Injury (HVIP-MLP Trial) A nationwide survey of 32 hospital-based violence intervention programs revealed that only 39% of representatives were aware of existing hospital policies ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0020138325000415

Evaluating the structural, financial, and legal aspects of ... Overall, HVIPs significantly reduced the incidence of violence-related injuries and recidivism rates among participants. Improvements in psychosocial outcomes ...

6. biologicalsciences.uchicago.edu biologicalsciences.uchicago.edu/news/medical-legal-partnerships-violence-recovery

Study shows medical-legal partnerships aid recovery for ... Through this financial return, the program aims to disrupt cycles of violence by stabilizing housing, food access, and employment. “When ...

7. uchicagomedicine.org uchicagomedicine.org/forefront/community-articles/2024/november/nih-grant-to-support-study-of-legal-aid-benefits-for-survivors-of-violence

$4.92 million NIH grant to support study of legal aid ... It is the first program in the country to provide bedside civil legal aid services within a hospital-based violence recovery program to patients ...