Firearm InjuryACTFASTNCT06302452
Adult Trauma Centers RE-AIM at Gun Safety
A study testing Adopting Comprehensive Training for FireArm Safety in Trauma Centers in people with Firearm Injury and Safety Issues, run by Johns Hopkins University at 3 sites in United States.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Firearm Injury, Safety Issues
- What is being tested?
- Adopting Comprehensive Training for FireArm Safety in Trauma Centers
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,776 participants
- Where
- 3 sitesUnited States
- Study dates
- 30 Oct 2024to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- trauma patients admitted to adult trauma inpatient services at participating institutions
- 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.
- trauma service physician, physician assistant, nurse practitioner, nurse or social worker at participating pediatric trauma center
Who cannot join
- none
- Patient participants
- 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
- none
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21287
Johns Hopkins Hospital
Baltimore, Maryland, 21287
WellSpan Health
York, Pennsylvania, 17402
About this study
Official title: 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.
- Conditions
- Firearm Injury, Safety Issues
- Being tested
- Adopting Comprehensive Training for FireArm Safety in Trauma Centers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adopting Comprehensive Training for FireArm Safety in Trauma CentersBehavioural
Firearm access screening, brief firearm safe storage intervention, and referral to community and preventive health resources
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Standard Care | No intervention | 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. Receives: Behavioral: Adopting Comprehensive Training for FireArm Safety in Trauma Centers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of admitted injured patients receiving each element of the ACTFAST Program
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.
Measured: 48 weeks
Percentage of admitted injured patients receiving elements of the ACTFAST Program
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.
Measured: Admission, 2 weeks post discharge
Patient firearm safety attitudes and behaviors as assessed by survey
This outcome will be measured using the patient survey data adapted from prior work by the study team.
Measured: 48 weeks
Secondary outcomes (1)
Clinician firearm safety knowledge and confidence as assessed by survey
This outcome will be measured using clinician survey data derived from multiple sources developed through the prior work of members of the study team.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start30 Oct 2024
- Primary completion1 Mar 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Firearm InjuryStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The trial uses a unidirectional crossover stepped wedge design with a sequential roll-out of the intervention, ACTFAST, RE-AIM implementation framework, over several discrete time points or "steps." Each of the three trauma centers will be randomly assigned to one step that will determine when they crossover from control to implementation. Data are collected over multiple wedges, each 4-6 months in length. During the first wedge, none of the participating trauma centers will receive ACTFAST. During the second wedge, the first trauma center completes the Adoption and Implementation period. Over the third wedge, the first center shifts to the Maintenance period, the second trauma center enters the Adoption and Implementation period, and the remaining cohort stays in the control condition. This pattern continues until all trauma centers have progressed from control condition through the active implementation period.
- Masking
- None (open label)
- Enrolment
- 1,776 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Rhode Island Hospital, WellSpan Health
- Responsible party
- Sponsor
- Investigators
- Katherine Hoops, MD, MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302452
- Sponsor's protocol ID
- IRB00433605
- Other IDs
- R01MD019173
- Acronym
- ACTFAST
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACTFAST: Urban and Rural Trauma Centers RE-AIM at Firearm Injury Prevention
- ClinicalTrials.gov ID
- NCT06302452
- Acronym / sponsor ID
- ACTFAST / IRB00433605
- Conditions
- Firearm Injury, Safety Issues
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,776 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Rhode Island Hospital, WellSpan Health
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The trial uses a unidirectional crossover stepped wedge design with a sequential roll-out of the intervention, ACTFAST, RE-AIM implementation framework, over several discrete time points or "steps." Each of the three trauma centers will be randomly assigned to one step that will determine when they crossover from control to implementation. Data are collected over multiple wedges, each 4-6 months in length. During the first wedge, none of the participating trauma centers will receive ACTFAST. During the second wedge, the first trauma center completes the Adoption and Implementation period. Over the third wedge, the first center shifts to the Maintenance period, the second trauma center enters the Adoption and Implementation period, and the remaining cohort stays in the control condition. This pattern continues until all trauma centers have progressed from control condition through the active implementation period.
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Standard Care | No intervention | –All trauma patients will receive standard routine care which may include some screening and counseling on gun safety. |
| ACTFAST Intervention | Experimental | Behavioral: Adopting Comprehensive Training for FireArm Safety in Trauma CentersDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- trauma patients admitted to adult trauma inpatient services at participating institutions
- 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.
Key exclusion criteria (7 listed)
- none
- Patient participants
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adopting Comprehensive Training for FireArm Safety in Trauma CentersFirearm access screening, brief firearm safe storage intervention, and referral to community and preventive health resources | Behavioural | ACTFAST Intervention |
Primary outcome
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.
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.
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.
1 secondary outcome
Clinician firearm safety knowledge and confidence as assessed by survey
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katherine Hoops, MD, MPH principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adopting Comprehensive Training for FireArm Safety in Trauma Centers in people with Firearm Injury and Safety Issues, run by Johns Hopkins University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of admitted injured patients receiving each element of the ACTFAST Program (time frame: 48 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.