ACTFAST: Pediatric Trauma Centers RE-AIM at Gun Safety

Sponsor
Johns Hopkins University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06123611
Collaborator
Centers for Disease Control and Prevention (U.S. Fed), Children's Hospitals and Clinics of Minnesota (Other), University of Utah (Other), Rhode Island Hospital (Other), Yale University (Other)
1,000
2
44.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adopting Comprehensive Training for FireArm Safety in Trauma centers
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Pediatric Trauma Centers RE-AIM at Gun Safety - Adopting Comprehensive Training for FireArm Safety in Trauma Centers
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Sep 30, 2026
Anticipated Study Completion Date :
Sep 30, 2027

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Standard Care

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

Experimental: ACTFAST Intervention

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

Outcome Measures

Primary Outcome Measures

  1. Implementation of Intervention [3 years]

    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.

  2. Parent firearm safety attitudes and behaviors [3 years]

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

Secondary Outcome Measures

  1. Clinician firearm safety knowledge and confidence [3 years]

    This outcome will be measured using clinician surveys derived from multiple sources developed through the prior work of members of the study team.

  2. Adolescent patient firearm safety attitudes and behaviors [3 years]

    Measure firearm injury prevention knowledge, attitudes and safe firearm practices of adolescent trauma patients (11-17 years) within participating pediatric level 1 trauma centers. This outcome will be measured using patient survey and interview adapted from prior work by the study team.

Eligibility Criteria

Criteria

Ages Eligible for Study:
11 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
For parents/guardians of pediatric trauma patients:
Inclusion Criteria:
  • live with an admitted pediatric trauma patient at a participating trauma center

  • be fluent in English or Spanish

Exclusion Criteria:
  • family members who do not live with the admitted pediatric trauma patient
For youth trauma patients:
Inclusion Criteria:
  • 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

Exclusion Criteria:
  • 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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Katherine Hoops, MD, PhD, Johns Hopkins School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT06123611
Other Study ID Numbers:
  • IRB00407213
  • CE003620
First Posted:
Nov 9, 2023
Last Update Posted:
Nov 9, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 9, 2023