Clinical Screening for Firearm Violence Risk

Multi-site External Validation and Improvement of a Clinical Screening Tool for Future Firearm Violence

The purpose of the proposed work is to harness cutting-edge machine learning methods to optimize prediction of future firearm violence in youth ages 18-24 so that prevention resources can be allocated efficiently.

Study Overview

• Status: Active, not recruiting
• Conditions: Firearm Injury

Detailed Description

Firearm violence is a public health crisis in the United States, and new epidemiological data suggest we may have reached a new endemic level of firearm mortality in recent years. Youth are disproportionately affected by firearm violence, with those age 18-24 being demonstrably the highest risk group. This study will recruit 1,500 youth age 18-24 from urban emergency departments (EDs) in three broadly different locales-Flint, Philadelphia, and Seattle-and administer a baseline survey covering several domains of potential risk factors for future violence, and follow up with those youth at 6- and 12-months to ascertain the primary outcome-firearm violence involvement (as victim or perpetrator, including threats and sub-clinical injuries)-as well as the secondary outcomes: high-risk firearm behaviors, non-firearm violence, and violent injury. This work will generate new insights into the prediction of firearm violence, and will lay the ground for future research involving the development and testing of interventions for interpersonal firearm violence both by identifying potential high-leverage modifiable predictive factors, and by focusing on youth most in need of intervention.

• Study Type: Observational
• Enrollment (Actual): 1506

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Presbyterian Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 24 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Youth aged 18-24 seeking care at the Emergency departments of Hurley Medical Center, the Hospital of University of Pennsylvania, Penn Presbyterian Medical Center, or Harborview Medical Center

Description

Inclusion Criteria:

• Flint, Philadelphia, or Seattle Youth between the ages of 18-24 seeking care for any reason at Hurley Medical Center, the Hospital of University of Pennsylvania, Penn Presbyterian Medical Center, or Harborview Medical Center Emergency Department
• Can provide consent for the study

Exclusion Criteria:

• Do not understand English (<1% in prior work)
• Unable to provide consent due to mental status (e.g., alcohol intoxication, acute psychosis) or medical instability.
• ED visit requiring intensive psychosocial services (e.g., sexual assault, psychosis, active suicidal ideation, or child abuse)
• In active police custody/prisoners (as they cannot provide consent)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
18-24 Year Olds in Emergency Department; Individuals age 18-24 recruited from one of the four study sites in Flint (1 hospital), Seattle (1 hospital), and Philadelphia (2 hospitals)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Firearm Violence Involvement	The primary outcome for this study is firearm violence involvement, as perpetrator or victim. This will be measured in part by the Conflict Tactics Scale 2, as established by Straus et al. CTS-2 is comprised of a 6-point scale, measuring how often the respondent has experienced each type of violence, ranging from never to more than 20 times. The primary outcome here will be a binary indicator comprised of any affirmative response to the questions asked as part of items 1-3 below, or any firearm events found from the objective chart review.; Two self-reported measurements of firearm violence perpetration adapted from the modified conflict tactics scale (CTS-2).; Two self-reported measurements of firearm violence victimization adapted from the modified conflict tactics scale (CTS-2).; Presentation to the emergency department for a firearm injury (ICD-10 codes: X72-X74, W32-W34, X93-X95), measured based on objective chart review during the one year following baseline.	1 Year After Baseline ED Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Risky Firearm Behaviors	As established by Carter et al based on a) twelve items from the Tulane Youth Study that measure firearm carriage and discharge in high-risky situations (e.g., discharging a firearm while committing a crime, or carrying a firearm while using drugs); b) the four firearm violence perpetration/victimization outcomes listed under the primary outcome; and c) firearm violence threats (as victim or perpetrator), as measured by the modified conflict tactics scale (CTS-2)	1 Year After Baseline ED Visit
Non-Firearm Violence	22 self-reported measurements for non-firearm violence perpetration (11 for partner, 11 for non-partner) adapted from the CTS-2, 22 self-reported measurements for non-firearm violence victimization (11 for partner, 11 for non-partner) adapted from the CTS-2, and 6 items about fighting, adapted from the National Longitudinal Study of Adolescent Health.	1 Year After Baseline ED Visit
Violent Injury	Presentation to the emergency department for any violent injury, measured based on objective chart review during the one year following baseline.	1 Year After Baseline ED Visit

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Jason E. Goldstick, PHD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2021
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: June 22, 2022
• First Submitted That Met QC Criteria: June 22, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 22, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Injury Prevention
• Other Study ID Numbers: HUM00188023; 1R01CE003294-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After study completion, de-identified data will be curated and uploaded through the Inter-University Consortium for Political and Social Research (ICPSR) run through the University of Michigan. ICPSR stores, curates, and provides access to data generated through social research studies in service to open science, which acts in service to optimized data sharing, rigorous detailing of study methods and citations for measures, and ensuring long-term preservation of the study data. Through the data curation process, data are cleaned and standardized for use, and data documentation is rigorously developed so that data sets and the associated documentation can be understood at a basic by any potential users. The uploaded data will be de-identified to ensure no linkages to individual research participants and will exclude variables that could lead to deductive disclosure of the identity of any individual subjects.
• IPD Sharing Time Frame: After the study is completed, with no specified time for when sharing will end.
• IPD Sharing Access Criteria: Registration with ICPSR and agreement to follow their rules and policies
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

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