Clinical trial NCT06302452: Adult Trauma Centers RE-AIM at Gun Safety
Official title: ACTFAST: Urban and Rural Trauma Centers RE-AIM at Firearm Injury Prevention
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Firearm Injury
Safety Issues
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Rhode Island Hospital
First posted: 2024-03-08
Enrollment: 1776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: OTHER

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. (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. (Primary Aim 2) Assess firearm injury prevention knowledge, attitudes, and safe storage practices among trauma patients treated within participating trauma centers.


Eligibility criteria: 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

Primary outcomes:
measure: Proportion of admitted injured patients receiving each element of the ACTFAST Program
timeFrame: 48 weeks
measure: Percentage of admitted injured patients receiving elements of the ACTFAST Program
timeFrame: Admission, 2 weeks post discharge
measure: Patient firearm safety attitudes and behaviors as assessed by survey
timeFrame: 48 weeks
Secondary outcomes:
measure: Clinician firearm safety knowledge and confidence as assessed by survey
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Katherine Hoops, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: