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Helping Individuals With Firearm Injuries (HIFI)

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ClinicalTrials.gov Identifier: NCT02630225
Recruitment Status : Active, not recruiting
First Posted : December 15, 2015
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
U.S. Department of Justice
City of Seattle
Laura and John Arnold Foundation
Information provided by (Responsible Party):
Ali Rowhani-Rahbar, University of Washington

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.


Condition or disease Intervention/treatment Phase
Wounds, Gunshot Behavioral: Critical Time Intervention Other: Treatment as Usual Behavioral: Motivational Interviewing Other: Multi-Agency Attention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Helping Individuals With Firearm Injuries: A Cluster Randomized Trial
Study Start Date : January 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

Treatment as Usual
Participants in this arm will receive the usual care offered to victims of gun shot wounds.
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




Primary Outcome Measures :
  1. Criminal Activity - Records [ Time Frame: Two years ]
    Criminal activity will be measured using Washington State arrest reports for any violent or nonviolent crime


Secondary Outcome Measures :
  1. Injury [ Time Frame: Two years ]
    Injury will be measured using information from medical records

  2. Death [ Time Frame: Two years ]
    All cause and cause-specific mortality will be measured using vital records.

  3. Impulsive-Premeditated Aggression Behavior [ Time Frame: One year ]
    This behavior will be measured using the Impulsive-Premeditated Aggression Scale (IPAS).

  4. Interpersonal Violence [ Time Frame: One year ]
    Interpersonal violence will be measured using Conflict Tactics Scale.

  5. Alcohol Use [ Time Frame: One year ]
    Alcohol use will be measured using the the Alcohol Use Identification Test (AUDIT).

  6. 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).

  7. Posttraumatic Stress Disorder (PTSD) [ Time Frame: One year ]
    PTSD will be measured using the Posttraumatic Stress Disorder (PTSD) Checklist - Civilian Version (PCL-C).

  8. Depression [ Time Frame: One year ]
    Depression will be measured using the Patient Health Questionnaire-8 (PHQ-8).

  9. Employment Status [ Time Frame: One year ]
    This will be measured using survey questions that elicit information about new, continued or discontinued employment.

  10. 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.

  11. Health-Related Quality of Life [ Time Frame: One year ]
    This will be measured using the Short Form Health Survey (SF-12).

  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.

  13. Perceived Social Support [ Time Frame: One year ]
    This will be measured using the Multidimensional Scale of Perceived Social Support.

  14. Housing Status [ Time Frame: One year ]
    Housing status will be measured using survey questions that elicit information about housing circumstances.

  15. 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.

  16. Criminal Activity - Records [ Time Frame: Two years ]
    Criminal activity will be measured using Washington State arrest reports differentiating arrests for violent or non-violent crimes.

  17. 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.

  18. Hospitalization - Records [ Time Frame: Two years ]
    Hospitalization will be measured using Washington State Comprehensive Hospital Abstract Reporting System (CHARS)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02630225


Locations
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United States, Washington
Harborview Medical Center
Seattle, Washington, United States, 98104
Sponsors and Collaborators
University of Washington
U.S. Department of Justice
City of Seattle
Laura and John Arnold Foundation
Investigators
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Principal Investigator: Ali Rowhani-Rahbar, MD, MPH University of Washignton

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Responsible Party: Ali Rowhani-Rahbar, Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT02630225     History of Changes
Other Study ID Numbers: STUDY00000852
First Posted: December 15, 2015    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
Keywords provided by Ali Rowhani-Rahbar, University of Washington:
case management
motivational interviewing
Additional relevant MeSH terms:
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Wounds, Gunshot
Wounds, Penetrating
Wounds and Injuries