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Preventing Retaliatory Gun Violence in Violently Injured Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04813185
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : July 26, 2022
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Virginia Commonwealth University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Violence Behavioral: Bridging the Gap Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 616 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Preventing Retaliatory Gun Violence in Violently Injured Adults: A RCT of a Hospital-Based Intervention
Actual Study Start Date : July 27, 2021
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Firearm-related violence [ Time Frame: 12-months ]
    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.

  2. Firearm-related re-injury [ Time Frame: 12-months ]
    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.

  3. Firearm-related mortality [ Time Frame: 12-months ]
    Collected from hospital records and National Death Index


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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
Contacts and Locations
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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): NCT04813185


Contacts
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Contact: Nicholas Thomson 804-628-5541 Nicholas.Thomson@vcuhealth.org

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Principal Investigator: Nicholas Thomson, PhD         
Sponsors and Collaborators
Virginia Commonwealth University
Centers for Disease Control and Prevention
Investigators
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Principal Investigator: Nicholas Thomson Virginia Commonwealth University
More Information
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04813185    
Other Study ID Numbers: HM20020621
R01CE003296 ( U.S. NIH Grant/Contract )
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No