Helping Individuals With Firearm Injuries (HIFI)
Primary Purpose
Wounds, Gunshot
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Critical Time Intervention
Treatment as Usual
Motivational Interviewing
Multi-Agency Attention
Sponsored by
About this trial
This is an interventional prevention trial for Wounds, Gunshot focused on measuring case management, motivational interviewing
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)
Sites / Locations
- Harborview Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention
Treatment as Usual
Arm Description
Participants in this arm will receive three intervention services in addition to treatment as usual services: A brief intervention including a feedback session utilizing principles of Motivational Interviewing (MI). Extended outreach services (6 months) using the Critical Time Intervention (CTI) approach. Multi-agency attention.
Participants in this arm will receive the usual care offered to victims of gun shot wounds.
Outcomes
Primary Outcome Measures
Criminal Activity - Records
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 Outcome Measures
Injury
Injury will be measured using information from medical records, the Washington State Comprehensive Hospital Abstract Reporting System, and the Emergency Department Information Exchange.
Death
All cause and cause-specific mortality will be measured using vital records.
Impulsive-Premeditated Aggression Behavior
This behavior will be measured using the Impulsive-Premeditated Aggression Scale (IPAS).
Interpersonal Violence
Interpersonal violence will be measured using Conflict Tactics Scale.
Alcohol Use
Alcohol use will be measured using the the Alcohol Use Identification Test (AUDIT).
Drug Abuse
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)
PTSD will be measured using the Posttraumatic Stress Disorder (PTSD) Checklist - Civilian Version (PCL-C).
Depression
Depression will be measured using the Patient Health Questionnaire-8 (PHQ-8).
Employment Status
This will be measured using survey questions that elicit information about new, continued or discontinued employment.
Educational Attainment
Education will be measured using survey that elicit information about enrollment in, completion of or discontinuation of educational activities.
Health-Related Quality of Life
This will be measured using the Short Form Health Survey (SF-12).
Satisfaction with Areas of Life
Satisfaction with specific areas of life, including study participation, will be measured using the Happiness Scale.
Perceived Social Support
This will be measured using the Multidimensional Scale of Perceived Social Support.
Housing Status
Housing status will be measured using survey questions that elicit information about housing circumstances.
Physical and Mental Health Service Utilization
This will be measured using survey questions that elicit information about use of physical and mental health services.
Criminal Activity - Records
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
Criminal activity will be measured self-reports of delinquency and criminal activity based on the scale used in the Pittsburgh Youth Study.
Hospitalization - Records
Hospitalization will be measured using Washington State Comprehensive Hospital Abstract Reporting System (CHARS)
Full Information
NCT ID
NCT02630225
First Posted
December 7, 2015
Last Updated
April 2, 2020
Sponsor
University of Washington
Collaborators
U.S. Department of Justice, City of Seattle, Arnold Ventures
1. Study Identification
Unique Protocol Identification Number
NCT02630225
Brief Title
Helping Individuals With Firearm Injuries
Acronym
HIFI
Official Title
Helping Individuals With Firearm Injuries: A Cluster Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
March 23, 2016 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
U.S. Department of Justice, City of Seattle, Arnold Ventures
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wounds, Gunshot
Keywords
case management, motivational interviewing
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
232 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in this arm will receive three intervention services in addition to treatment as usual services:
A brief intervention including a feedback session utilizing principles of Motivational Interviewing (MI).
Extended outreach services (6 months) using the Critical Time Intervention (CTI) approach.
Multi-agency attention.
Arm Title
Treatment as Usual
Arm Type
Other
Arm Description
Participants in this arm will receive the usual care offered to victims of gun shot wounds.
Intervention Type
Behavioral
Intervention Name(s)
Critical Time Intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
Services provided by HMC physicians and staff that are part of standard care for patients with firearm-related injuries. This care could include:
All necessary medical care and scheduled follow-ups with subspecialty services
Evaluation by social work with referral to appropriate community services
Screening for alcohol use
Discharge planning services
Financial counseling
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
A brief intervention to elicit the goals and needs of participants. As needed, this will included referrals to community resources.
Intervention Type
Other
Intervention Name(s)
Multi-Agency Attention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Criminal Activity - Records
Description
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
Time Frame
Two years
Secondary Outcome Measure Information:
Title
Injury
Description
Injury will be measured using information from medical records, the Washington State Comprehensive Hospital Abstract Reporting System, and the Emergency Department Information Exchange.
Time Frame
Two years
Title
Death
Description
All cause and cause-specific mortality will be measured using vital records.
Time Frame
Two years
Title
Impulsive-Premeditated Aggression Behavior
Description
This behavior will be measured using the Impulsive-Premeditated Aggression Scale (IPAS).
Time Frame
One year
Title
Interpersonal Violence
Description
Interpersonal violence will be measured using Conflict Tactics Scale.
Time Frame
One year
Title
Alcohol Use
Description
Alcohol use will be measured using the the Alcohol Use Identification Test (AUDIT).
Time Frame
One year
Title
Drug Abuse
Description
Drug abuse will be measured using The National Institute on Drug Abuse - Modified Alcohol, Smoking and Substance Abuse Involvement Screening Test (NIDA - Modified ASSIST).
Time Frame
One year
Title
Posttraumatic Stress Disorder (PTSD)
Description
PTSD will be measured using the Posttraumatic Stress Disorder (PTSD) Checklist - Civilian Version (PCL-C).
Time Frame
One year
Title
Depression
Description
Depression will be measured using the Patient Health Questionnaire-8 (PHQ-8).
Time Frame
One year
Title
Employment Status
Description
This will be measured using survey questions that elicit information about new, continued or discontinued employment.
Time Frame
One year
Title
Educational Attainment
Description
Education will be measured using survey that elicit information about enrollment in, completion of or discontinuation of educational activities.
Time Frame
One year
Title
Health-Related Quality of Life
Description
This will be measured using the Short Form Health Survey (SF-12).
Time Frame
One year
Title
Satisfaction with Areas of Life
Description
Satisfaction with specific areas of life, including study participation, will be measured using the Happiness Scale.
Time Frame
One year
Title
Perceived Social Support
Description
This will be measured using the Multidimensional Scale of Perceived Social Support.
Time Frame
One year
Title
Housing Status
Description
Housing status will be measured using survey questions that elicit information about housing circumstances.
Time Frame
One year
Title
Physical and Mental Health Service Utilization
Description
This will be measured using survey questions that elicit information about use of physical and mental health services.
Time Frame
One year
Title
Criminal Activity - Records
Description
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.
Time Frame
Two years
Title
Criminal Activity - Self Report
Description
Criminal activity will be measured self-reports of delinquency and criminal activity based on the scale used in the Pittsburgh Youth Study.
Time Frame
One year
Title
Hospitalization - Records
Description
Hospitalization will be measured using Washington State Comprehensive Hospital Abstract Reporting System (CHARS)
Time Frame
Two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ali Rowhani-Rahbar, MD, MPH
Organizational Affiliation
University of Washignton
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34304738
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.
Results Reference
derived
PubMed Identifier
33405475
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.
Results Reference
derived
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Helping Individuals With Firearm Injuries
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