Pediatric Trauma Centers RE-AIM at Gun Safety

NCT06123611 | Enrolling By Invitation DMC

• 2 other identifiers: IRB00407213CE003620
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Universal firearm injury and violence prevention counseling of parents and patients has been recommended by multiple national organizations for over a decade, yet clinicians rarely deliver this counseling. Barriers to its implementation must be addressed in order to effectively deliver firearm related injury prevention efforts. This study will implement a universal firearm injury prevention initiative within a national cohort of three pediatric trauma centers. The investigator's long-term goal is to demonstrate best practices for pediatric trauma center-based firearm injury prevention strategies that promote safe storage practices and reduce firearm related injury and death. This research will test the effectiveness of a comprehensive training strategy for improving the implementation of a universal firearm injury prevention effort, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), to 1) increase the adoption, implementation and sustainability of a universal firearm injury prevention initiative within participating pediatric level 1 trauma centers; 2) increase firearm safety knowledge, attitudes and safe firearm storage practices among parents of pediatric trauma patients and youth patients treated within participating pediatric level 1 trauma centers, and 3) increase trauma center clinicians' firearm safety knowledge and confidence in delivering a firearm safety intervention.

Conditions

Firearm Injury; Safety Issues

Outcome Measures

Primary Outcomes (2)

• Implementation of Intervention

  This outcome will be measured using chart review protocols examining rates of firearm access screening, documentation of firearm safety counseling, documentation of referral to community based resources and connection to medical homes as well as patient hospitalization characteristics including admission diagnosis, injury severity and patient demographic characteristics.

  3 years

• Parent firearm safety attitudes and behaviors

  This outcome will be measured using parent survey and interview adapted from prior work by the study team.

  3 years

Secondary Outcomes (2)

• Clinician firearm safety knowledge and confidence

  3 years

• Adolescent patient firearm safety attitudes and behaviors

  3 years

Study Arms (2)

Standard Care

NO INTERVENTION

In the pre-implementation period, all trauma patients will receive standard routine care. Which may include some screening and counseling on gun safety.

ACTFAST Intervention

EXPERIMENTAL

During the implementation and maintenance periods, all trauma patients will receive study activities including firearm access screening, counseling on safe storage practices, and referral to safe storage and other community resources as appropriate.

Behavioral: Adopting Comprehensive Training for FireArm Safety in Trauma centers

Interventions

Adopting Comprehensive Training for FireArm Safety in Trauma centers BEHAVIORAL

Firearm access screening, brief firearm safe storage intervention, and referral to community and preventive health resources

ACTFAST Intervention

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• live with an admitted pediatric trauma patient at a participating trauma center
• be fluent in English or Spanish

You may not qualify if:

• \- family members who do not live with the admitted pediatric trauma patient
• For youth trauma patients:
• Must be between the ages of 11-17 years
• admitted to a participating trauma inpatient service for an injury
• fluent in English or Spanish
• able to provide written assent and parent able to provide written consent
• Youth who are prisoners or in police custody
• Youth who are admitted due to suicide attempt
• Youth with acute conditions that would preclude provision of informed consent (i.e., acute psychosis, altered mental status, cognitive impairment)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Centers for Disease Control and Prevention: collaborator
• Children's Hospitals and Clinics of Minnesota: collaborator
• University of Utah: collaborator
• Rhode Island Hospital: collaborator
• Yale University: collaborator

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Interventions

Trauma Centers

Intervention Hierarchy (Ancestors)

Emergency Service, Hospital; Hospital Departments; Hospital Administration; Health Facility Administration; Health Facilities; Health Care Facilities Workforce and Services; Emergency Medical Services; Health Services; Organization and Administration; Health Services Administration

Study Officials

• Katherine Hoops, MD, PhD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 9, 2023
• Study Start: February 25, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)