Clinical trial NCT02630225: Helping Individuals With Firearm Injuries
Official title: Helping Individuals With Firearm Injuries: A Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wounds, Gunshot
Keywords: case management
motivational interviewing
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: U.S. Department of Justice
name: City of Seattle
name: Arnold Ventures
First posted: 2015-12-15
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators will conduct a cluster randomized trial of an intervention program that combines a hospital-based intervention, structured outreach program, and multi-agency attention. The goal of the study is to test the effect of this multi-component intervention on criminal activity, injury, substance abuse, mental health, quality of life, violent behavior, and death.

Investigators aim to enroll a total of 300 patients admitted to the Harborview Medical Center (HMC) for firearm-related injuries. Patients will be randomized to receive a multi-component intervention or treatment as usual. All participants will complete surveys at the time of study consent (baseline) and then at designated time points for 12 months post-consent. Study staff will routinely collect participant records from Washington State Patrol records, HMC medical records, Washington State trauma registry, Washington State Emergency Department Information Exchange, Administrative Office of the Courts, and vital records. The investigators will test the impact of the intervention against standard care. The hypothesis is that participants in the intervention group will see greater improvements in aforementioned outcomes than those in the control group.

Detailed description: About 250 individuals present to an emergency department in King County, primarily Harborview Medical Center (HMC), for firearm-related injuries each year. Almost two-third of these patients require admission for their injuries. While the number of patients with firearm injuries who present to HMC is relatively small, these individuals are at substantially increased risk of subsequent re-hospitalization for another firearm or assault-related injury, arrest for firearm-related or violent crime, non-firearm-related nonviolent crime or firearm-related death in the five years after discharge from the hospital. Thus, interventions among this high risk population have the potential to reduce recidivism, morbidity, and mortality as well as decrease firearm violence and its consequences in the community.

Patients with gunshot wounds (GSWs) seen at HMC receive many services; however, currently there is no standardized intervention offered to GSW patients. A number of hospitals across the country have created violence prevention and intervention programs to help patients who sustain violent injuries. These programs engage patients in the hospital during their recovery period, which is seen as an opportunity ("teachable moment") to change their life and reduce retaliation and recidivism. As a result of the growing number of violence prevention and intervention program, the National Network of Hospital-based Violence Intervention Programs, has been established. Through working groups, meetings, e-newsletter, and conferences, Network members collaborate in research and evaluation, explore opportunities for funding sustainability, develop and share best practices, and identify ways to collectively have an impact on policy. While the creation of this infrastructure is a step in the right direction, researchers have not rigorously tested the effectiveness of these intervention programs. Specifically, no trials have evaluated the effectiveness of hospital-based violence intervention programs offered to GSW victims.

The investigators aim to conduct a cluster randomized trial of an violence intervention program that combines a brief, hospital-based intervention, a structured outreach program, and multi-agency attention. Study staff will provide a brief intervention derived from motivational interviewing (MI). MI is is a patient-centered behavioral technique based on the stages of change model and attempts to engage patients in order to find reason to change behavior. By empathetically exploring ambivalent feelings about health-related behavior, MI encourages reduction in risky behavior. Research has demonstrated the effectiveness of providing MI-based brief interventions in the Emergency Department (ED) or inpatient wards, primarily for alcohol use disorders but also for violent behaviors. Specifically, brief, MI interventions have been successful at reducing youth violence in large urban populations, with effects sustained through one year. Additionally, a behavioral-based intervention including MI targeting adolescents admitted to HMC with trauma showed a reduction in weapon carriage during the year post-hospitalization.

A longitudinal outreach intervention program provides the added benefit of continued engagement. GSW patients must transition back to the community after their hospitalization, and the transitional period, when patients must navigate a complex and fragmented system of care, is especially challenging. Providing GSW patients with outreach and follow-up after the healthcare encounter holds promise for reducing their future violence and criminal activity. The Critical Time Intervention (CTI) approach may provide a strong framework for providing these patients with appropriate outreach and follow-up. Strong evidence supports CTI's effectiveness. The CTI model meets the Coalition for Evidence-based Policy's rigorous "Top Tier" standard for interventions: well-designed and implemented randomized controlled trials, preferably conducted in typical community settings, \[that\] produced sizable, sustained benefits to participants and/or society. CTI is a time-limited, evidence-based case management model that mobilizes support for society's most vulnerable individuals during periods of transition such as discharge from inpatient services to the community. It facilitates community integration and continuity of care by ensuring that a person has enduring ties to their community and support systems during these critical periods. CTI has been used worldwide among veterans, people with mental illness, homeless or incarcerated individuals, and many other groups. From the beginning, CTI was thought of as an intervention that could be applied in myriad contexts. This approach has the potential to provide an intervention framework for a second tier outreach to GSW victims in King and neighboring counties.

Eligibility criteria: Inclusion Criteria:

* Able to provide consent within 4 weeks following hospital discharge
* Able to understand and speak English
* Able to provide at least one mode of direct or alternate contact (e.g., cell phone, land line, e-mail, friend, or relative)
* Planning to live in King, Pierce, Snohomish, Thurston or Yakima counties for at least 6 months subsequent to hospital discharge
* Receiving treatment for a GSW at HMC and returning to the community, and not prison following treatment
* Being treated for gunshot wounds from assaults or accidents (self- or other-inflicted)

Exclusion Criteria:

* 17 years of age or younger
* Unable to provide consent (including those with severe neurologic damage) within 4 weeks following hospital discharge
* Unable to understand or speak English
* Unable to provide any mode of direct or alternate contact
* Not living in King, Pierce, Snohomish, Thurston or Yakima counties, or planning to move outside of those counties within 6 months following hospital discharge
* Not receiving treatment for a GSW at HMC
* Not returning to the community following hospital discharge (e.g., being sent to a rehabilitation center, skilled nursing facility, or prison)
* Incarcerated at the time of GSW injury
* Being treated for an intentional, self-inflicted gunshot wound injuries (e.g. suicide attempts)

Primary outcomes:
measure: Criminal Activity - Records
timeFrame: Two years
Secondary outcomes:
measure: Injury
timeFrame: Two years
measure: Death
timeFrame: Two years
measure: Impulsive-Premeditated Aggression Behavior
timeFrame: One year
measure: Interpersonal Violence
timeFrame: One year
measure: Alcohol Use
timeFrame: One year
measure: Drug Abuse
timeFrame: One year
measure: Posttraumatic Stress Disorder (PTSD)
timeFrame: One year
measure: Depression
timeFrame: One year
measure: Employment Status
timeFrame: One year
measure: Educational Attainment
timeFrame: One year
measure: Health-Related Quality of Life
timeFrame: One year
measure: Satisfaction with Areas of Life
timeFrame: One year
measure: Perceived Social Support
timeFrame: One year
measure: Housing Status
timeFrame: One year
measure: Physical and Mental Health Service Utilization
timeFrame: One year
measure: Criminal Activity - Records
timeFrame: Two years
measure: Criminal Activity - Self Report
timeFrame: One year
measure: Hospitalization - Records
timeFrame: Two years
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washignton
name: Ali Rowhani-Rahbar, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Floyd AS, Lyons VH, Whiteside LK, Haggerty KP, Rivara FP, Rowhani-Rahbar A. Barriers to recruitment, retention and intervention delivery in a randomized trial among patients with firearm injuries. Inj Epidemiol. 2021 Jul 26;8(1):37. doi: 10.1186/s40621-021-00331-z.
citation: Lyons VH, Floyd AS, Griffin E, Wang J, Hajat A, Carone M, Benkeser D, Whiteside LK, Haggerty KP, Rivara FP, Rowhani-Rahbar A. Helping individuals with firearm injuries: A cluster randomized trial. J Trauma Acute Care Surg. 2021 Apr 1;90(4):722-730. doi: 10.1097/TA.0000000000003056.