- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06302452
Adult Trauma Centers RE-AIM at Gun Safety (ACTFAST)
ACTFAST: Urban and Rural Trauma Centers RE-AIM at Firearm Injury Prevention
The goal of this interventional study is to evaluate the implementation and effectiveness of a comprehensive a universal firearm injury prevention program, ACTFAST (Adopting Comprehensive Training for FireArm Safety in Trauma centers), in level 1 trauma centers. The main aims of the study are:
- (Primary Aim 1) Increase the adoption, implementation, and maintenance of a universal firearm injury prevention intervention at three participating trauma centers in the mid-Atlantic states;
- (Primary Aim 2) Assess firearm injury prevention knowledge, attitudes, and safe storage practices among trauma patients treated within participating trauma centers.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Hospital
-
Baltimore, Maryland, United States, 21287
- Johns Hopkins Bayview Medical Center
-
-
Pennsylvania
-
York, Pennsylvania, United States, 17402
- WellSpan Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Electronic Medical Record (EMR) Participants:
Inclusion Criteria:
- trauma patients admitted to adult trauma inpatient services at participating institutions
Exclusion Criteria:
- none
Patient participants
Inclusion Criteria:
- at least 18 years of age;
- admitted to a participating trauma service for an injury;
- fluent in English or Spanish;
- able to provide informed consent.
Exclusion Criteria:
- prisoner or in police custody;
- admitted due to suicide attempt
- any acute conditions that would preclude provision of informed consent or assent (i.e., acute psychosis, altered mental status, cognitive impairment).
Staff participants
Inclusion Criteria:
- trauma service physician, physician assistant, nurse practitioner, nurse or social worker at participating pediatric trauma center
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
|
No Intervention: No Intervention: Standard Care
All trauma patients will receive standard routine care which may include some screening and counseling on gun safety.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of admitted injured patients receiving each element of the ACTFAST Program
Time Frame: 48 weeks
|
ACTFAST components will be collected through retrospective data abstraction of each site's electronic medical record to determine if admitted injured patients received the Screening, Brief Intervention and Referral to Treatment (SBIRT) program components during the different phases of the study.
|
48 weeks
|
|
Percentage of admitted injured patients receiving elements of the ACTFAST Program
Time Frame: Admission, 2 weeks post discharge
|
Among those eligible, compared to pre-implementation, there will be a difference in patients receiving each element of the ACTFAST program as measured by participant survey responses gathered during the participant's admission and 2-weeks post-discharge from survey data derived from multiple sources developed through the prior work of members of the study team.
|
Admission, 2 weeks post discharge
|
|
Patient firearm safety attitudes and behaviors as assessed by survey
Time Frame: 48 weeks
|
This outcome will be measured using the patient survey data adapted from prior work by the study team.
|
48 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinician firearm safety knowledge and confidence as assessed by survey
Time Frame: 48 weeks
|
This outcome will be measured using clinician survey data derived from multiple sources developed through the prior work of members of the study team.
|
48 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Katherine Hoops, MD, MPH, Johns Hopkins University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00433605
- R01MD019173 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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