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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06123611
Other study ID # IRB00407213
Secondary ID CE003620
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 25, 2024
Est. completion date September 30, 2027

Study information

Verified date March 2024
Source Johns Hopkins University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1000
Est. completion date September 30, 2027
Est. primary completion date September 30, 2026
Accepts healthy volunteers No
Gender All
Age group 11 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Johns Hopkins Medicine Baltimore Maryland

Sponsors (6)

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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Clinician firearm safety knowledge and confidence This outcome will be measured using clinician surveys derived from multiple sources developed through the prior work of members of the study team. 3 years
Secondary Adolescent patient firearm safety attitudes and behaviors 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. 3 years
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