Adult Trauma Centers RE-AIM at Gun Safety

NCT06302452 | Enrolling By Invitation

• 2 other identifiers: IRB00433605R01MD019173
• Study Type: interventional
• Target: 1,776
• Locations: 1 country
• Sites: 3

Brief 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. 1.(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;
2. 2.(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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  48 weeks

Secondary Outcomes (1)

• Clinician firearm safety knowledge and confidence as assessed by survey

  48 weeks

Study Arms (2)

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.

Behavioral: Adopting Comprehensive Training for FireArm Safety in Trauma Centers

Interventions

Adopting Comprehensive Training for FireArm Safety in Trauma Centers BEHAVIORAL

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

ACTFAST Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• trauma patients admitted to adult trauma inpatient services at participating institutions

You may not qualify if:

• none
• Patient participants
• 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.
• 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
• trauma service physician, physician assistant, nurse practitioner, nurse or social worker at participating pediatric trauma center
• none

Sponsors & Collaborators

• Johns Hopkins University: lead
• Rhode Island Hospital: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• WellSpan Health: collaborator

Study Sites (3)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21287, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

WellSpan Health

York, Pennsylvania, 17402, United States

Location

MeSH Terms

Interventions

Trauma Centers

Intervention Hierarchy (Ancestors)

Emergency Service, Hospital; Hospital Departments; Hospital Administration; Health Facility Administration; Health Facilities; Health Care Facilities Workforce and Services; Emergency Medical Services; Health Services; Organization and Administration; Health Services Administration

Study Officials

• Katherine Hoops, MD, MPH

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 8, 2024
• Study Start: October 30, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): April 30, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)