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

Trial Summary

What is the purpose of this 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 violence-related outcomes, legal needs, health-related quality of life, PTSD symptoms, and perceived stress.

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 data supports the effectiveness of the treatment Recovery Legal Care for Traumatic Injury?

Hospital-based violence intervention programs (HVIPs), which are part of the Recovery Legal Care treatment, have been shown to effectively reduce the chances of people getting injured again after a violent incident by providing support and services to those at high risk. ^{1 2 3 4 5}

Is Recovery Legal Care safe for humans?

The available research on Hospital-Based Violence Intervention Programs (HVIP), which are similar to Recovery Legal Care, does not report any specific safety concerns for participants. These programs focus on providing support and resources to reduce the risk of reinjury, and there is no evidence suggesting they are unsafe for humans. ^{1 4 5 6 7}

How is the Recovery Legal Care treatment different from other treatments for traumatic injury?

Recovery Legal Care, also known as Medical Legal Partnership (MLP) or Hospital-Based Violence Intervention Program (HVIP), is unique because it addresses not only the medical needs but also the legal and social issues that may contribute to reinjury. This approach focuses on preventing future injuries by tackling the underlying social and legal challenges faced by patients, which is different from traditional treatments that primarily focus on physical recovery. ^{1 3 4 8 9}

Research Team

TANYA L ZAKRISON, MD, MPH

Principal Investigator

University of Chicago

ELIZABETH L TUNG, MD, MS

Principal Investigator

University of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Implementation of a Novel Home Visiting Nurse Pilot Program for Victims of Violent Penetrating Injury. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Boston Violence Intervention Advocacy Program: Challenges and Opportunities for Client Engagement and Goal Achievement. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Law Enforcement and Patient Privacy Among Survivors of Violence: A Nationwide Mixed-Methods Study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Hospital-based violence intervention programs targeting adult populations: an Eastern Association for the Surgery of Trauma evidence-based review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Long-term evaluation of a hospital-based violence intervention program using a regional health information exchange. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

How policy makers can smooth the way for communication-and- resolution programs. [2014]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Action after Adverse Events in Healthcare: An Integrative Literature Review. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Characteristics of Adult Patients for Violence-Related Injuries Presenting to a Level 1 Trauma Center in Midwest United States. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Beyond Recidivism: Hospital-Based Violence Intervention and Early Health and Social Outcomes. [2022]