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Clinical Trials/NCT02630225
NCT02630225
Completed
Not Applicable

Helping Individuals With Firearm Injuries: A Cluster Randomized Trial

University of Washington1 site in 1 country232 target enrollmentMarch 23, 2016
ConditionsWounds, Gunshot

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Wounds, Gunshot
Sponsor
University of Washington
Enrollment
232
Locations
1
Primary Endpoint
Criminal Activity - Records
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 23, 2016
End Date
December 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ali Rowhani-Rahbar

Associate Professor

University of Washington

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)

Outcomes

Primary Outcomes

Criminal Activity - Records

Time Frame: Two years

Criminal activity will be measured using Washington State arrest reports and charges from the Administrative Office of the Courts for any violent or nonviolent crime

Secondary Outcomes

  • Interpersonal Violence(One year)
  • Alcohol Use(One year)
  • Satisfaction with Areas of Life(One year)
  • Impulsive-Premeditated Aggression Behavior(One year)
  • Perceived Social Support(One year)
  • Criminal Activity - Self Report(One year)
  • Physical and Mental Health Service Utilization(One year)
  • Death(Two years)
  • Depression(One year)
  • Educational Attainment(One year)
  • Health-Related Quality of Life(One year)
  • Housing Status(One year)
  • Criminal Activity - Records(Two years)
  • Hospitalization - Records(Two years)
  • Injury(Two years)
  • Drug Abuse(One year)
  • Posttraumatic Stress Disorder (PTSD)(One year)
  • Employment Status(One year)

Study Sites (1)

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