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Helping Individuals With Firearm Injuries (HIFI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02630225
Recruitment Status : Completed
First Posted : December 15, 2015
Last Update Posted : April 6, 2020
Sponsor:
Collaborators:
U.S. Department of Justice
City of Seattle
Arnold Ventures
Information provided by (Responsible Party):
Ali Rowhani-Rahbar, University of Washington

Tracking Information
First Submitted Date  ICMJE December 7, 2015
First Posted Date  ICMJE December 15, 2015
Last Update Posted Date April 6, 2020
Actual Study Start Date  ICMJE March 23, 2016
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2015)
  • Criminal Activity - Records [ Time Frame: One year ]
    Criminal activity will be measured using Washington State arrest reports.
  • Criminal Activity - Self Report [ Time Frame: One year ]
    Criminal activity will be measured self-reports of delinquency and criminal activity based on the scale used in the Pittsburgh Youth Study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2020)
  • Injury [ Time Frame: Two years ]
    Injury will be measured using information from medical records, the Washington State Comprehensive Hospital Abstract Reporting System, and the Emergency Department Information Exchange.
  • Death [ Time Frame: Two years ]
    All cause and cause-specific mortality will be measured using vital records.
  • Impulsive-Premeditated Aggression Behavior [ Time Frame: One year ]
    This behavior will be measured using the Impulsive-Premeditated Aggression Scale (IPAS).
  • Interpersonal Violence [ Time Frame: One year ]
    Interpersonal violence will be measured using Conflict Tactics Scale.
  • Alcohol Use [ Time Frame: One year ]
    Alcohol use will be measured using the the Alcohol Use Identification Test (AUDIT).
  • Drug Abuse [ Time Frame: One year ]
    Drug abuse will be measured using The National Institute on Drug Abuse - Modified Alcohol, Smoking and Substance Abuse Involvement Screening Test (NIDA - Modified ASSIST).
  • Posttraumatic Stress Disorder (PTSD) [ Time Frame: One year ]
    PTSD will be measured using the Posttraumatic Stress Disorder (PTSD) Checklist - Civilian Version (PCL-C).
  • Depression [ Time Frame: One year ]
    Depression will be measured using the Patient Health Questionnaire-8 (PHQ-8).
  • Employment Status [ Time Frame: One year ]
    This will be measured using survey questions that elicit information about new, continued or discontinued employment.
  • Educational Attainment [ Time Frame: One year ]
    Education will be measured using survey that elicit information about enrollment in, completion of or discontinuation of educational activities.
  • Health-Related Quality of Life [ Time Frame: One year ]
    This will be measured using the Short Form Health Survey (SF-12).
  • Satisfaction with Areas of Life [ Time Frame: One year ]
    Satisfaction with specific areas of life, including study participation, will be measured using the Happiness Scale.
  • Perceived Social Support [ Time Frame: One year ]
    This will be measured using the Multidimensional Scale of Perceived Social Support.
  • Housing Status [ Time Frame: One year ]
    Housing status will be measured using survey questions that elicit information about housing circumstances.
  • Physical and Mental Health Service Utilization [ Time Frame: One year ]
    This will be measured using survey questions that elicit information about use of physical and mental health services.
  • 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 differentiating arrests for violent or non-violent crimes.
  • Criminal Activity - Self Report [ Time Frame: One year ]
    Criminal activity will be measured self-reports of delinquency and criminal activity based on the scale used in the Pittsburgh Youth Study.
  • Hospitalization - Records [ Time Frame: Two years ]
    Hospitalization will be measured using Washington State Comprehensive Hospital Abstract Reporting System (CHARS)
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2015)
  • Injury [ Time Frame: One year ]
    Injury will be measured using information from medical records
  • Death [ Time Frame: One year ]
    All cause and cause-specific mortality will be measured using vital records.
  • Impulsive-Premeditated Aggression Behavior [ Time Frame: One year ]
    This behavior will be measured using the Impulsive-Premeditated Aggression Scale (IPAS).
  • Interpersonal Violence [ Time Frame: One year ]
    Interpersonal violence will be measured using Conflict Tactics Scale.
  • Alcohol Use [ Time Frame: One year ]
    Alcohol use will be measured using the the Alcohol Use Identification Test (AUDIT).
  • Drug Abuse [ Time Frame: One year ]
    Drug abuse will be measured using The National Institute on Drug Abuse - Modified Alcohol, Smoking and Substance Abuse Involvement Screening Test (NIDA - Modified ASSIST).
  • Posttraumatic Stress Disorder (PTSD) [ Time Frame: One year ]
    PTSD will be measured using the Posttraumatic Stress Disorder (PTSD) Checklist - Civilian Version (PCL-C).
  • Depression [ Time Frame: One year ]
    Depression will be measured using the Patient Health Questionnaire-8 (PHQ-8).
  • Employment Status [ Time Frame: One year ]
    This will be measured using survey questions that elicit information about new, continued or discontinued employment.
  • Educational Attainment [ Time Frame: One year ]
    Education will be measured using survey that elicit information about enrollment in, completion of or discontinuation of educational activities.
  • Health-Related Quality of Life [ Time Frame: One year ]
    This will be measured using the Short Form Health Survey (SF-12).
  • Satisfaction with Areas of Life [ Time Frame: One year ]
    Satisfaction with specific areas of life, including study participation, will be measured using the Happiness Scale.
  • Perceived Social Support [ Time Frame: One year ]
    This will be measured using the Multidimensional Scale of Perceived Social Support.
  • Housing Status [ Time Frame: One year ]
    Housing status will be measured using survey questions that elicit information about housing circumstances.
  • Physical and Mental Health Service Utilization [ Time Frame: One year ]
    This will be measured using survey questions that elicit information about use of physical and mental health services.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Helping Individuals With Firearm Injuries
Official Title  ICMJE Helping Individuals With Firearm Injuries: A Cluster Randomized Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Wounds, Gunshot
Intervention  ICMJE
  • Behavioral: Critical Time Intervention

    The Critical Time Intervention approach strengthens an individual's long-term ties to services, family and friends as well as provides emotional and practical support to individuals during the critical time of transition back to the community. CTI contains three phases:

    Phase 1 - The Support Specialist gets to know the individual, assesses the individual's need and implements a transition plan intended to link the individual to services and supports in the community.

    Phase 2 -- The Support Specialist monitors and adjusts the systems of support that were developed in Phase 1.

    Phase 3 -- The Support Specialist helps the individual develop and implement a plan to achieve long-term goals and finalizes the transfer of responsibilities to caregivers and community providers.

  • Other: Treatment as Usual

    Services provided by HMC physicians and staff that are part of standard care for patients with firearm-related injuries. This care could include:

    1. All necessary medical care and scheduled follow-ups with subspecialty services
    2. Evaluation by social work with referral to appropriate community services
    3. Screening for alcohol use
    4. Discharge planning services
    5. Financial counseling
  • Behavioral: Motivational Interviewing
    A brief intervention to elicit the goals and needs of participants. As needed, this will included referrals to community resources.
  • Other: Multi-Agency Attention
    Intervention cases will receive attention from a multidisciplinary team of professionals. This team will help the study Support Specialist identify service recommendations and provide case management guidance.
Study Arms  ICMJE
  • Experimental: Intervention

    Participants in this arm will receive three intervention services in addition to treatment as usual services:

    1. A brief intervention including a feedback session utilizing principles of Motivational Interviewing (MI).
    2. Extended outreach services (6 months) using the Critical Time Intervention (CTI) approach.
    3. Multi-agency attention.
    Interventions:
    • Behavioral: Critical Time Intervention
    • Other: Treatment as Usual
    • Behavioral: Motivational Interviewing
    • Other: Multi-Agency Attention
  • Treatment as Usual
    Participants in this arm will receive the usual care offered to victims of gun shot wounds.
    Intervention: Other: Treatment as Usual
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2019)
232
Original Estimated Enrollment  ICMJE
 (submitted: December 14, 2015)
200
Actual Study Completion Date  ICMJE December 31, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02630225
Other Study ID Numbers  ICMJE STUDY00000852
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ali Rowhani-Rahbar, University of Washington
Study Sponsor  ICMJE University of Washington
Collaborators  ICMJE
  • U.S. Department of Justice
  • City of Seattle
  • Arnold Ventures
Investigators  ICMJE
Principal Investigator: Ali Rowhani-Rahbar, MD, MPH University of Washignton
PRS Account University of Washington
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP