跳至主要内容
临床试验/NCT06736730
NCT06736730尚未招募不适用

A Proposal to Establish the Mississippi Violence Injury Prevention (VIP) Program

University of Mississippi Medical Center2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
500
试验地点
2
主要终点
Incidence of death and gunshot injuries

研究概览

简要总结

This clinical trial is designed to evaluate the effectiveness of three interventions aimed at preventing violence and supporting those affected by it. Over next three years, the impact of these interventions on key areas will be measured, including the incidence of firearm injuries, the recovery of victims, the occurrence of retaliation and re-injury, and health economics. The interventions are developed based on data collected from a comprehensive needs assessment, community summit, retrospective medical chart reviews, and focus group sessions. The defined interventions are as follows:

Intervention A - Integration of an existing community-based intervention program with Hospital services intervention B - Unrestricted Cash Assistance Intervention C - Mobile Community Support Services

Additionally, the investigators will implement a detailed violence-focused survey for firearm survivors at the time of study enrollment. Follow-up is planned at 3,6 and 12 months. The results of this trial (including analyses of firearm injury rates, recovery outcomes, retaliation/re-injury occurrences, and economic data) will be shared with the affected communities and stakeholders to promote ongoing improvement and support.

详细描述

To achieve the goals of this trial, the investigators will activate community-focused interventions developed during the first phase of the study to help enroll participants in the study using a stepped wedge cluster design based on their dwelling addresses.

The investigators will formalize the 9 clusters using geographic and demographic data specific to Jackson, Mississippi. Patients presenting in the ER with gunshot injuries will be randomized based on their dwelling address, which will be matched to their corresponding cluster's randomization assignments for the interventions of VIP (Operation Good), Cash Assistance, and Mobile Community Support Services. Any patient with a gunshot injury, regardless of their dwelling address, will be eligible for consent to participate in the longitudinal follow-up of the study. Those not in a currently active clusters at the time of injury will serve as controls for the survey results. Study investigators plan to enroll up to 15 active patients per cluster per year for this follow-up, and community events will be aligned with the same cluster random assignments used for patient interventions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or older
  • Firearm injury within the last 24 hours prior to their arrival at the University of Mississippi Medical Center
  • Residency/home address within one of the designated clusters.
  • Be approached by the research team within 72 hours of arrival.
  • Ability to understand the clinical trial, sign the consent form, and commit to follow-ups.
  • Ability and willingness to engage in all aspects of the intervention arm (must agree to Operation Good, Survey Participation, and Unrestricted Cash Assistance, these interventions/evaluations cannot be separated)

排除标准

  • Self-inflicted gunshot wounds
  • Less than 18 years of age
  • Patients who are incarcerated or in-custody
  • Patients who are unable to understand the clinical trial or sign consent (whether from intoxication, injury, or other cause)
  • Patients unable to commit to follow-up or be contacted through routine means

结局指标

主要结局

Incidence of death and gunshot injuries

时间窗: Three years starting upon implementation of the intervention protocol

The data will be collected from hospital and JPD records. Excluding self-inflicted such as suicide or adjudicated to be accidental/unintentional.

次要结局

  • Incidence of PTSD, Score of perceived stress and social cohesion(Three years starting upon implementation of the intervention protocol)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验