Recovery Legal Care Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 202
- 试验地点
- 3
- 主要终点
- Firearm victimization and aggression
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 64 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
HVIP
This arm includes patients receiving usual care (HVIP only).
干预措施: HVIP Standard of Care (Other)
HVIP-MLP
This arm includes patients receiving usual care and also support from Recovery Legal Care (HVIP+MLP)
干预措施: Recovery Legal Care (Other)
HVIP-MLP
This arm includes patients receiving usual care and also support from Recovery Legal Care (HVIP+MLP)
干预措施: HVIP Standard of Care (Other)
结局指标
主要结局
Firearm victimization and aggression
时间窗: 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.
次要结局
- 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)