NCT02630225

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
232

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 7, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

March 23, 2016

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

3.3 years

First QC Date

December 7, 2015

Last Update Submit

April 2, 2020

Conditions

Keywords

case managementmotivational interviewing

Outcome Measures

Primary Outcomes (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

    Two years

Secondary Outcomes (18)

  • Injury

    Two years

  • Death

    Two years

  • Impulsive-Premeditated Aggression Behavior

    One year

  • Interpersonal Violence

    One year

  • Alcohol Use

    One year

  • +13 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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 InterventionOther: Treatment as UsualBehavioral: Motivational InterviewingOther: Multi-Agency Attention

Treatment as Usual

OTHER

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

Other: Treatment as Usual

Interventions

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

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

InterventionTreatment as Usual

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

Intervention

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.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Wounds, Gunshot

Interventions

TherapeuticsMotivational Interviewing

Condition Hierarchy (Ancestors)

Wounds, PenetratingWounds and Injuries

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ali Rowhani-Rahbar, MD, MPH

    University of Washignton

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 15, 2015

Study Start

March 23, 2016

Primary Completion

June 30, 2019

Study Completion

December 31, 2019

Last Updated

April 6, 2020

Record last verified: 2020-04

Locations