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Wounds, GunshotHIFINCT02630225

Helping Individuals With Firearm Injuries

A study testing Critical Time Intervention, Treatment as Usual and Motivational Interviewing in people with Wounds, Gunshot, run by University of Washington at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Wounds, Gunshot
What is being tested?
Critical Time Intervention, Treatment as Usual and Motivational Interviewing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
232 participants
Where
1 siteUnited States
Study dates
23 Mar 2016to 31 Dec 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Harborview Medical Center

    Seattle, Washington, 98104

Other trials in United States

About this study

Official title: Helping Individuals With Firearm Injuries: A Cluster Randomized Trial

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.

Read the 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.

Conditions
Wounds, Gunshot
Being tested
Critical Time Intervention, Treatment as Usual, Motivational Interviewing, Multi-Agency Attention
Keywords
case management, motivational interviewing
Medical subject headings
Wounds, Gunshot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Critical Time InterventionBehavioural

    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.

  • Treatment as UsualOther

    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
  • Motivational InterviewingBehavioural

    A brief intervention to elicit the goals and needs of participants. As needed, this will included referrals to community resources.

  • Multi-Agency AttentionOther

    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 groups in NCT02630225
Study groupRoleWhat they receive
InterventionExperimentalParticipants 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.
Receives: Behavioral: Critical Time Intervention; Other: Treatment as Usual; Behavioral: Motivational Interviewing; Other: Multi-Agency Attention
Treatment as UsualOtherParticipants in this arm will receive the usual care offered to victims of gun shot wounds.
Receives: Other: Treatment as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Two years

Secondary outcomes (18)
  1. Injury

    Injury will be measured using information from medical records, the Washington State Comprehensive Hospital Abstract Reporting System, and the Emergency Department Information Exchange.

    Measured: Two years

  2. Death

    All cause and cause-specific mortality will be measured using vital records.

    Measured: Two years

  3. Impulsive-Premeditated Aggression Behavior

    This behavior will be measured using the Impulsive-Premeditated Aggression Scale (IPAS).

    Measured: One year

  4. Interpersonal Violence

    Interpersonal violence will be measured using Conflict Tactics Scale.

    Measured: One year

  5. Alcohol Use

    Alcohol use will be measured using the the Alcohol Use Identification Test (AUDIT).

    Measured: One year

  6. 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).

    Measured: One year

  7. Posttraumatic Stress Disorder (PTSD)

    PTSD will be measured using the Posttraumatic Stress Disorder (PTSD) Checklist - Civilian Version (PCL-C).

    Measured: One year

  8. Depression

    Depression will be measured using the Patient Health Questionnaire-8 (PHQ-8).

    Measured: One year

  9. Employment Status

    This will be measured using survey questions that elicit information about new, continued or discontinued employment.

    Measured: One year

  10. Educational Attainment

    Education will be measured using survey that elicit information about enrollment in, completion of or discontinuation of educational activities.

    Measured: One year

  11. Health-Related Quality of Life

    This will be measured using the Short Form Health Survey (SF-12).

    Measured: One year

  12. Satisfaction with Areas of Life

    Satisfaction with specific areas of life, including study participation, will be measured using the Happiness Scale.

    Measured: One year

  13. Perceived Social Support

    This will be measured using the Multidimensional Scale of Perceived Social Support.

    Measured: One year

  14. Housing Status

    Housing status will be measured using survey questions that elicit information about housing circumstances.

    Measured: One year

  15. Physical and Mental Health Service Utilization

    This will be measured using survey questions that elicit information about use of physical and mental health services.

    Measured: One year

  16. 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.

    Measured: Two years

  17. 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.

    Measured: One year

  18. Hospitalization - Records

    Hospitalization will be measured using Washington State Comprehensive Hospital Abstract Reporting System (CHARS)

    Measured: Two years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2015 (estimated)
  2. Study start23 Mar 2016
  3. Primary completion30 Jun 2019
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
232 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02630225
Sponsor's protocol ID
STUDY00000852
Acronym
HIFI
Status last verified
Apr 2020
First submitted
7 Dec 2015
Last updated
6 Apr 2020
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 34304738
  • 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.

    PubMed 33405475

Questions about this trial

What is this clinical trial studying?

A study testing Critical Time Intervention, Treatment as Usual and Motivational Interviewing in people with Wounds, Gunshot, run by University of Washington at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Criminal Activity - Records (time frame: Two years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02630225, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.

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