Preventing Retaliatory Gun Violence in Violently Injured Adults

Preventing Retaliatory Gun Violence in Violently Injured Adults: A RCT of a Hospital-Based Intervention

The purpose of this research study is to find out if a hospital-based violence intervention (Bridging the Gap) is effective for reducing violence. The researchers think that adults who receive Bridging the Gap will see greater improvements than those who do not receive the intervention. This study will allow them to learn more about the intervention's effectiveness. The study will also help them understand if the violence intervention affects other behaviors, such as firearm use, drug use, aggression, risky behaviors, and rates of violent re-injury.

Study Overview

• Status: Recruiting
• Conditions: Violence
• Intervention / Treatment: Behavioral: Bridging the Gap

Detailed Description

Approximately 616 patients will enroll in this study. Participants will be asked to complete sessions about behavior, personality, and experiences. Participants will be randomized into a study group (either Bridging the Gap or Treatment as Usual) by drawing a number. If patients agree to the study but do not like the group they are assigned to, they can request to switch groups. Participants assigned to the Treatment as Usual intervention will receive a brief violence awareness brochure during your hospital stay. Participants assigned to the Bridging the Gap intervention will receive an in-hospital intervention and, once released from the hospital, will receive 6-months of community case management services. The study team thinks that adults who receive the Bridging the Gap intervention will see greater improvements than adults who do not receive the intervention. This study will allow them to learn more about the intervention's effectiveness.

During these study sessions participants will complete questionnaires about exposure to traumatic events, symptoms of trauma, history of suicide, aggression and violence, antisocial personality traits, illegal behaviors, substance use, and mental health. Participants will complete several tasks which measure cognitive ability, such as problem-solving, attention/concentration, and decision-making. They will also complete a clinical interview that covers antisocial personality traits and behaviors, including history of aggressive behavior and substance use. These interviews will be video recorded. These recordings will be used to help score the interviews and for training purposes. Information will also be collected from participant's medical records, including demographic information, history and reason for past hospitalizations, mental health history, and substance use reports, as well as a criminal background check.

The surveys take about 2 hours to complete. Participants will complete these questionnaires again 6 and 12 months later. Participation in this study will last up to 12 months.

• Study Type: Interventional
• Enrollment (Estimated): 616
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicholas Thomson; Phone Number: 804-628-5541; Email: Nicholas.Thomson@vcuhealth.org

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Recruiting
      • Virginia Commonwealth University
      • Principal Investigator: Nicholas Thomson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• They receive treatment in the hospital for a violence-related injury (e.g., gunshot wound)
• They are 18 years or older
• They are English speaking
• They are eligible for BTG services (which includes living within the BTG catchment area for the hospital; Richmond City and neighboring counties)

Exclusion Criteria:

• Non-English speaking
• Age <18
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment as usual; Adults who will not receive BTG services and will receive treatment as usual (TAU) in the hospital.
Experimental: In-hospital intervention; Adults randomized to Bridging the Gap (BTG) services will receive a hospital-based violence prevention program with 6-months of community case management and a firearm counseling program.	Behavioral: Bridging the Gap; Bridging the Gap Bridging the Gap is a hybrid model for violence prevention which integrates a hospital-based brief violence intervention (BVI) delivered to the patient while in hospital with a wrap-around community case management prevention strategy. Firearm Counseling Program The firearm counseling program was developed to be administered in the hospital alongside the 6-step intervention program, as well as in the patient's home after hospital discharge. The firearm safety counseling program includes 3 components aimed at understanding patient risk, reducing firearm-related violence risk-factors, and helping patients increase firearm safety practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Firearm-related violence	Number of firearm-related violence incidents will be measured multiple ways including self-report and a semi-structured clinical assessment of non-convicted firearm-related violence. Incidents will be summed to yield a single count of unique firearm-related violence incidents for each participant.	12-months
Firearm-related re-injury	Number of firearm-related re-injury incidents will be measured multiple ways including self-report and hospital records. Incidents will be summed to yield a single count of unique firearm-related re-injuries for each participant.	12-months
Firearm-related mortality	Collected from hospital records and National Death Index	12-months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Nicholas Thomson, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2021
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HM20020621; R01CE003296 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No