- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06123611
Pediatric Trauma Centers RE-AIM at Gun Safety (ACTFAST)
March 13, 2026 updated by: Johns Hopkins University
Pediatric Trauma Centers RE-AIM at Gun Safety - Adopting Comprehensive Training for FireArm Safety in Trauma Centers
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
Firearm access screening, brief firearm safe storage intervention, and referral to community and preventive health resources
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implementation of Intervention
Time Frame: 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.
|
3 years
|
|
Parent firearm safety attitudes and behaviors
Time Frame: 3 years
|
This outcome will be measured using parent survey and interview adapted from prior work by the study team.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician firearm safety knowledge and confidence
Time Frame: 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.
|
3 years
|
|
Adolescent patient firearm safety attitudes and behaviors
Time Frame: 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.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine Hoops, MD, PhD, Johns Hopkins School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 25, 2024
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
September 30, 2027
Study Registration Dates
First Submitted
November 1, 2023
First Submitted That Met QC Criteria
November 8, 2023
First Posted (Actual)
November 9, 2023
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 13, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00407213
- CE003620 (Other Grant/Funding Number: Centers for Disease Control and Prevention)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
At the conclusion of the study, deidentified data will be made publicly available.
Due to the sensitive nature of the topics being discussed, individual participant data will not be made available to other researchers outside of the study team.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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