Clinical trial NCT06886776: Implementing a Secure Firearm Storage Program in Illinois Health Centers in Partnership with AllianceChicago and the Illinois Primary Health Care Association (COMMUNITY ASPIRE)
Official title: Implementing a Secure Firearm Storage Program in Illinois Health Centers in Partnership with AllianceChicago and the Illinois Primary Health Care Association (COMMUNITY ASPIRE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide
Keywords: Implementation science
Firearms
Suicide
Pediatrics
Federally qualified health centers
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: AllianceChicago
name: Illinois Primary Health Care Association
name: University of Pennsylvania
name: National Institute of Nursing Research (NINR)
First posted: 2025-03-20
Enrollment: 666
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped wedge randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This randomized controlled trial will take place in up to 15 community health centers across the state of Illinois. Researchers will be studying S.A.F.E. Firearm, a program that aims to increase secure storage of firearms in homes with children. Specifically, S.A.F.E. Firearm includes a brief conversation between pediatric clinicians and parents about secure firearm storage and an offer of a free cable firearm lock within the well-child visit. Researchers will also study a package of strategies to help pediatric clinics incorporate this new practice. The strategies include training for clinic personnel and facilitation, or tailored problem-solving support.

The questions the study aims to answer are:

* How effective is the package of strategies at helping pediatric clinics adopt this new practice?
* How effective is the S.A.F.E. Firearm program at changing parents' and guardians' firearm storage behavior?

Some parents and guardians will be invited to complete a brief survey after their visit about their experiences receiving S.A.F.E. Firearm. Some community health center personnel will also be invited to complete an interview about their experiences with S.A.F.E. Firearm and the package of strategies.

Detailed description: While some large health systems have successfully adopted secure firearm storage programs such as S.A.F.E. Firearm into routine practice, there is limited research on the implementation of secure firearm storage programs in community settings, such as community health centers, which serve large populations of Americans. These settings often face challenges such as financial pressures and high staff turnover, which were made worse by the COVID-19 pandemic. Therefore, before deploying a secure firearm storage program in this new setting, adaptation is needed. As part of Aim 1 of the grant funding this project, the research team is working with local community-based organizations, firearm safety experts, community health center personnel, and parents and guardians (hereafter, "parents") to understand the changes that need to be made to the S.A.F.E. Firearm program and the package of implementation strategies that have been successfully used in previous studies to help pediatric clinics adopt this new practice (training, facilitation, other strategies selected in tandem with partners in the adaptation process). The research team will incorporate needed changes before the present trial will begin.

In the present study, the research team will conduct a hybrid type III effectiveness-implementation trial to test the effect of the adapted S.A.F.E. Firearm program and associated strategies. The trial will be conducted across pediatric well-visits in community health centers across the state of Illinois using a stepped wedge design. Clinics will be randomized into clusters of clinics and the implementation approach (staff training, facilitation, other strategies selected in tandem with partners in the adaptation process) will be activated upon the start of each step.

Aims for the study include:

Aim 2. We will conduct a pragmatic hybrid type III stepped wedge effectiveness-implementation randomized controlled trial with community health centers across Illinois to test the effectiveness of our adapted implementation approach (training and facilitation emphasizing S.A.F.E. Firearm delivery) on parent-reported receipt of S.A.F.E. Firearm (i.e., reach; primary implementation outcome). We will also assess secondary implementation outcomes (stage of implementation, cost, acceptability) and effectiveness outcomes (parent firearm storage behavior).

Aim 3. We will use mixed methods to identify mechanisms. First, we will conduct interviews to understand constituent perspectives on implementation mechanisms and equitable intervention receipt. Second, we will evaluate reach and firearm storage behavior by demographic characteristics and social determinants of health.

Eligibility criteria: Inclusion Criteria:

Parent participants

* Be a parent of a child ages 0-17 who has a well-visit at a participating health care clinic in the state of Illinois
* Attend the child's well-visit

Health care personnel

* Be employed at a participating health care clinic in the state of Illinois
* Aged 18+ years

Exclusion Criteria:

* None

Primary outcomes:
measure: Parent-reported reach of S.A.F.E. Firearm
timeFrame: Reach will be collected via survey sent to parents after well-visits for the 3-year study period (baseline through sustainment phases)
Secondary outcomes:
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Illinois Primary Health Care Association
state: Illinois
Study officials:
References: