Clinical trial NCT06712940: Supportive Hospital-Based Intervention for Firearm Trauma
Official title: Preventing Youth Firearm Violence in New Orleans: A Hospital-Initiated Community Integrated Approach
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gun Violence Prevention
Adolescent Behavior
Keywords: Firearm
Violence prevention
Youth
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2024-12-03
Enrollment: 350
Sex: ALL
Minimum age (years): 16
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a quasi-experimental design, specifically a non-randomized controlled trial (NCT) designed to test the effects of gun violence reduction intervention including MI for youth ages 16-24 years old who present to the Emergency Department or ICU Spirit of Charity Trauma Center (SCTC) at University Medical Centers or another area hospital in New Orleans, Louisiana following a gunshot injury or stab wound. The study will utilize an enrollment strategy that involves alternating, across recruitment days, the assigned study condition. Thus, Day 1 participants would be enrolled into TAU, Day 2 participants would be enrolled in MI-case management condition, Day 3 participants would be enrolled in TAU, etc. This proposed design will minimize any confounds associated with self-selection while possibly increasing enrollment rate.

Research questions include:

1. Will youth allocated to the MI prevention condition have safer firearm related behaviors and beliefs compared to the TAU control condition at 6 months post- enrollment?
2. Will youth allocated to the MI prevention condition have reduced gun violence recidivism compared to the TAU control condition at 18 months post-enrollment.
3. How do youth's social and normative environments influence their gun behaviors and attitudes?

Researchers will compare intervention and TAU arms to see if there are any differences in outcome measures.

Participants will:

1. complete study eligibility assessment, be assigned to one of two conditions depending on the date of assessment, consent, and enroll in the Emergency Department (ED) or inpatient unit of hospital by a study team member,
2. participate in one of two conditions: MI administered by a licensed clinical social worker, or treatment as usual control group (TAU) administered by a study team member (n=170 per condition)
3. complete three surveys (baseline, 3-month, and 6-month) conducted by a study team member
4. 18-month post examination of participant hospital records
5. have the option to complete a 1-1.5 hour interview, 1-3 months after the 6-month survey is completed (n=50)

Detailed description: The long-term goal of this study is to decrease community rates of youth gun violence. The objective is to test the long-term effects of a hospital-initiated intervention and examine how social contexts influence its adoption and sustained effects. This study will be conducted in collaboration with the Spirit of Charity Trauma Center at University Medical Center to implement a hospital-initiated intervention to reduce gun violence amongst older youth.

The multi-faceted intervention includes motivational interviewing and firearm safety training as part of a broader risk reduction effort involving case management. The proposed study, known as the Supportive Hospital-Based Intervention for Firearm Trauma (SHIFT), will employ a mixed methods approach, including a quasi-experimental study, to test the efficacy of the Motivational Interviewing (MI) intervention compared to treatment as usual (TAU) control condition. The hypothesis of this study is that this harm reduction intervention will be more effective in changing firearm-related behaviors and beliefs than the control condition at 3- and 6-months and reducing gun violence at 18-months post-baseline. If successful, the proposed intervention would significantly reduce gun violence and gun violence recidivism amongst youth in our community. The investigators will test our hypothesis via three specific aims:

1. To establish the effects (at 6 months) of a hospital-initiated, community-integrated practice approach on firearm related behaviors and beliefs amongst older youth (16 to 24 years). Our primary working hypothesis is that youth allocated to the MI prevention condition will have safer firearm related behaviors and beliefs compared to the TAU control condition at 6 months post- enrollment.
2. To establish the effects (at 18 months) of hospital-initiated, community-integrated practice- based approach on rates of gun violence amongst older youth (16 to 24 years). Our primary working hypothesis is that youth allocated to the MI prevention condition will have reduced gun violence recidivism compared to the TAU control condition at 18 months post-enrollment. Gun violence constructs to be measured include hospital readmittance for gun violence wounds, arrest records for gun violence, and frequency of carrying or using a gun.
3. To gain in-depth understanding of older youth's (16 to 24 years) social and normative environments that may influence such a practice. Supplementing quantitative findings with a qualitative study of older youth will more fully capture the social contexts supporting or hindering gun violence behavior changes supported by our practice-based approach. Identifying and examining these factors in-depth will contribute to a more nuanced understanding of how to support the long-term durability of approach effects.

Eligibility criteria: Inclusion Criteria:

* 16 to 24 years old
* gunshot wound, stab wound, or assault related blunt force trauma injury treated at University Medical Center
* reside in the state of Louisiana
* capacity to provide voluntary informed consent or assent as approved by the Institutional Review Board of Tulane University

Exclusion Criteria:

* not voluntarily agreeing to participate
* not available to participate in study activities in a private room
* age under 16 or over 24
* do not reside in the state of Louisiana
* not acknowledging English as their first language
* being in the judgment of the trauma surgery service as too physically compromised to participate
* intellectual disability as estimated by clinician judgment following mental status examination
* current psychosis as evidenced by structured clinical interview and mental status examination that are administered on as needed basis
* current legal detention status
* injury was a result of intimate partner violence
* does not have the capacity to provide voluntary informed consent or assent as approved by the Institutional Review Board of Tulane University

Primary outcomes:
measure: Firearm carriage
timeFrame: At time of enrollment
measure: Firearm storage
timeFrame: At time of enrollment
measure: Firearm beliefs
timeFrame: At time of enrollment
measure: Firearm carriage
timeFrame: 3 months post-enrollment
measure: Firearm storage
timeFrame: 3-months post enrollment
measure: Firearm beliefs
timeFrame: 3 months post-enrollment
measure: Firearm carriage
timeFrame: 6 months post-enrollment
measure: Firearm storage
timeFrame: 6 months post-enrollment
measure: Firearm beliefs
timeFrame: 6 months post-enrollment
Secondary outcomes:
measure: Arrest records for gun violence
timeFrame: 18 months post study activity completion
measure: Hospital readmittance for gun violence wounds
timeFrame: 18 months post study activity completion
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Tulane School of Public Health and Tropical Medicine
state: Louisiana
Study officials:
affiliation: Tulane University
name: Julia M Fleckman, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lundahl BW, Kunz C, Brownell C, Tollefson D, Burke BL. A meta-analysis motivational interviewing: twenty-five years of empirical studies. Research on Social Work Practice. 2010;20(2):137-160.
citation: Purtle J, Rich JA, Fein JA, James T, Corbin TJ. Hospital-Based Violence Prevention: Progress and Opportunities. Ann Intern Med. 2015 Nov 3;163(9):715-7. doi: 10.7326/M15-0586. Epub 2015 Aug 25. No abstract available.
citation: Purtle J, Dicker R, Cooper C, Corbin T, Greene MB, Marks A, Creaser D, Topp D, Moreland D. Hospital-based violence intervention programs save lives and money. J Trauma Acute Care Surg. 2013 Aug;75(2):331-3. doi: 10.1097/TA.0b013e318294f518. No abstract available.
citation: Pino EC, Fontin F, James TL, Dugan E. Mechanism of penetrating injury mediates the risk of long-term adverse outcomes for survivors of violent trauma. J Trauma Acute Care Surg. 2022 Mar 1;92(3):511-519. doi: 10.1097/TA.0000000000003364.
citation: Fein JA, Mollen CJ, Greene MB. The assault-injured youth and the emergency medical system: What can we do? Clinical Pediatric Emergency Medicine. 2013;14(1):47-55.
citation: Liebschutz J, Schwartz S, Hoyte J, Conoscenti L, Christian AB Sr, Muhammad L, Harper D, James T. A chasm between injury and care: experiences of black male victims of violence. J Trauma. 2010 Dec;69(6):1372-8. doi: 10.1097/TA.0b013e3181e74fcf.
citation: Mathe N, Johnson ST, Wozniak LA, Majumdar SR, Johnson JA. Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design. Trials. 2015 Aug 25;16:375. doi: 10.1186/s13063-015-0904-x.
citation: Mikhail JN, Nemeth LS. Trauma Center Based Youth Violence Prevention Programs: An Integrative Review. Trauma Violence Abuse. 2016 Dec;17(5):500-519. doi: 10.1177/1524838015584373. Epub 2015 Jun 29.