Clinical trial NCT06736730: Mississippi Violence Injury Prevention (VIP) Program
Official title: A Proposal to Establish the Mississippi Violence Injury Prevention (VIP) Program
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Gun Shot Wound
Keywords: Violence prevention
Community-based interventions
Health economics of violence
Clinical trial on violence prevention
Firearm injury prevention
Retaliation and reinjury
Lead sponsor: University of Mississippi Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-12-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Jackson, MS will be divided into 9 clusters (with defined geographic boundaries and know population totals) and those clusters will undergo randomization for activation. 3 clusters will be activated each year for three years and those living in the activated clusters will receive the interventions upon activation. Results from participants living in active clusters will be compared to those not in active clusters until at the end of the three years study period all clusters will be activated.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Incidence of death and gunshot injuries
timeFrame: Three years starting upon implementation of the intervention protocol
Secondary outcomes:
measure: Incidence of PTSD, Score of perceived stress and social cohesion
timeFrame: Three years starting upon implementation of the intervention protocol
Other outcomes:
Locations:
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
Study officials:
affiliation: Associate Dean For Research And Scholarship
name: Lei Zhang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.