Mississippi Violence Injury Prevention (VIP) Program

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Hospital-Linked Violence Intervention Program
  Activation of Operation Good, our community partner with a history of direct violence interruption in the streets and longitudinal health and wellness services to firearm injured patient (i.e. linking and aiding those who have suffered from violent injury to mental healthcare, job services, educational services)
• Поведенческое Mobile Community Event Support
  A menu of services provided to the community in an activated cluster where funding will be provided to assist that community in holding events that support overall health and wellness (community clean-up, legal advisory services, pop-up clinic for blood pressure checks).
• Поведенческое Unrestricted Cash Assistance
  A participant in an activated cluster after firearm injury will receive two disbursements of 500$. One at the time of initial hospital evaluation and a second disbursement \~1 month later to offset the financial burden associated with firearm injury on the individual.

Первичные конечные точки

• Incidence of death and gunshot injuries [Срок оценки: Three years starting upon implementation of the intervention protocol]

Вторичные конечные точки (1)

• Incidence of PTSD, Score of perceived stress and social cohesion [Срок оценки: Three years starting upon implementation of the intervention protocol]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Mississippi Medical Center — Jackson

Публикации

• Formica MK. An Eye on Disparities, Health Equity, and Racism-The Case of Firearm Injuries in Urban Youth in the United States and Globally. Pediatr Clin North Am. 2021 Apr;68(2):389-399. doi: 10.1016/j.pcl.2020.12.009. Epub 2021 Jan 26. PMID 33678293
• Girling AJ, Hemming K. Statistical efficiency and optimal design for stepped cluster studies under linear mixed effects models. Stat Med. 2016 Jun 15;35(13):2149-66. doi: 10.1002/sim.6850. Epub 2016 Jan 7. PMID 26748662
• Hooper R, Teerenstra S, de Hoop E, Eldridge S. Sample size calculation for stepped wedge and other longitudinal cluster randomised trials. Stat Med. 2016 Nov 20;35(26):4718-4728. doi: 10.1002/sim.7028. Epub 2016 Jun 28. PMID 27350420
• Morris MC, Rao U, Garber J. Cortisol responses to psychosocial stress predict depression trajectories: social-evaluative threat and prior depressive episodes as moderators. J Affect Disord. 2012 Dec 20;143(1-3):223-30. doi: 10.1016/j.jad.2012.05.059. Epub 2012 Aug 1. PMID 22858210
• Zun LS, Downey L, Rosen J. The effectiveness of an ED-based violence prevention program. Am J Emerg Med. 2006 Jan;24(1):8-13. doi: 10.1016/j.ajem.2005.05.009. PMID 16338502
• Bauer DJ, Preacher KJ, Gil KM. Conceptualizing and testing random indirect effects and moderated mediation in multilevel models: new procedures and recommendations. Psychol Methods. 2006 Jun;11(2):142-63. doi: 10.1037/1082-989X.11.2.142. PMID 16784335

Идентификаторы

NCT: NCT06736730 · UMMC-IRB-2024-347 · 4UH3MD018298-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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