Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
500 participants
INTERVENTIONAL
2025-03-01
2028-06-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
NONE
Study Groups
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Active Arm
Intervention: It includes three key components:
1. Unrestricted Cash Assistance provided to individuals to support their immediate needs,
2. Mobile Community Support Services that offer on-site assistance and resources, and
3. Activation of Operation Good with coordination between hospital and community services to ensure seamless support for individuals affected by violence, promoting recovery and reducing the risk of re-injury or retaliation.
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)
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).
Unrestricted Cash Assistance
A participant in an activated cluster after firearm injury will receive two disbursements of 500$. One at the time of initial hospital evaluation and a second disbursement \~1 month later to offset the financial burden associated with firearm injury on the individual.
In-Active Arm
This group will receive no intervention beyond the standard care provided in the hospital setting. No additional services, cash assistance, or community-based support will be offered. This arm will serve as a comparison group to evaluate the effectiveness of the intervention.
No interventions assigned to this group
Interventions
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Hospital-Linked Violence Intervention Program
Activation of Operation Good, our community partner with a history of direct violence interruption in the streets and longitudinal health and wellness services to firearm injured patient (i.e. linking and aiding those who have suffered from violent injury to mental healthcare, job services, educational services)
Mobile Community Event Support
A menu of services provided to the community in an activated cluster where funding will be provided to assist that community in holding events that support overall health and wellness (community clean-up, legal advisory services, pop-up clinic for blood pressure checks).
Unrestricted Cash Assistance
A participant in an activated cluster after firearm injury will receive two disbursements of 500$. 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
National Institute on Minority Health and Health Disparities (NIMHD)
NIH
University of Mississippi Medical Center
OTHER
Responsible Party
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Principal Investigators
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Lei Zhang, PHD
Role: PRINCIPAL_INVESTIGATOR
Associate Dean For Research And Scholarship
Locations
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University of Mississippi Medical Center
Jackson, Mississippi, United States
Countries
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Central Contacts
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Facility Contacts
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Lei Zhang, PHD
Role: backup
Matthew E. Kutcher, MD
Role: backup
References
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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.
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.
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.
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.
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.
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.
Related Links
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Mississippi Violence Injury Prevention Program Overview,
Other Identifiers
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UMMC-IRB-2024-347
Identifier Type: -
Identifier Source: org_study_id
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