Implementing a Secure Firearm Storage Program in Illinois Health Centers in Partnership with AllianceChicago and the Illinois Primary Health Care Association (COMMUNITY ASPIRE)

NCT ID: NCT06886776

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 666 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2028-08-31

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.

Conditions

Suicide

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Baseline/usual care

During the baseline data collection phase, no individuals will be exposed to S.A.F.E. Firearm. No training or facilitation will be received. The length of the baseline data collection phase will differ between each "wedge" (i.e., group of clinics) depending on when the group is randomly assigned to cross over into the implementation phase. All sites will be in the baseline data collection phase for at least six months before having the interventions activated.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Implementation phase (training and facilitation received, S.A.F.E. Firearm delivered)

Once a group of clinics crosses over from the baseline data collection phase, the implementation approaches (e.g., training, facilitation) and the S.A.F.E. Firearm program will be enacted. S.A.F.E. Firearm involves pediatric clinicians having a secure firearm storage discussion with a parent or guardian during their child's well-visit and offering them a free cable firearm lock. This implementation phase will last for 12 months.

Group Type: EXPERIMENTAL

Implementation package (training and facilitation)

Intervention Type: BEHAVIORAL

Training includes an initial presentation on S.A.F.E. Firearm, S.A.F.E. Firearm informational guides and other resources to support delivery, and recommendations for additional, optional self-guided learning resources.

Facilitation will last twelve months at each site. It may involve 1) a pre-implementation readiness assessment for each clinic to identify potential implementation barriers and develop relationships with constituents; 2) kick-off meetings at the launch of the trial, at which clinic staff will identify how and where S.A.F.E. Firearm will be implemented within the clinic; 3) goal-setting within the first few months of the program; 4) trouble-shooting to address barriers identified during the pre-implementation readiness assessment and emergent challenges; and 5) designing a sustainment plan to maintain S.A.F.E. Firearm for future years.

Sustainment (training and facilitation removed)

Following the conclusion of the 12 months in which the implementation approaches (training and facilitation) are used at a clinic, outcomes will be assessed for the duration of the study during a "sustainment" window.

No additional training or facilitation will be received during the sustainment period following the experimental period. However, clinics will still continue to deliver S.A.F.E. Firearm.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Implementation package (training and facilitation)

Training includes an initial presentation on S.A.F.E. Firearm, S.A.F.E. Firearm informational guides and other resources to support delivery, and recommendations for additional, optional self-guided learning resources.

Facilitation will last twelve months at each site. It may involve 1) a pre-implementation readiness assessment for each clinic to identify potential implementation barriers and develop relationships with constituents; 2) kick-off meetings at the launch of the trial, at which clinic staff will identify how and where S.A.F.E. Firearm will be implemented within the clinic; 3) goal-setting within the first few months of the program; 4) trouble-shooting to address barriers identified during the pre-implementation readiness assessment and emergent challenges; and 5) designing a sustainment plan to maintain S.A.F.E. Firearm for future years.

Intervention Type: BEHAVIORAL

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AllianceChicago

OTHER

Sponsor Role: collaborator

Illinois Primary Health Care Association

UNKNOWN

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: collaborator

National Institute of Nursing Research (NINR)

NIH

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Rinad Beidas

Ralph Seal Paffenbarger Professor and Chair, Department of Medical Social Sciences

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Illinois Primary Health Care Association

Springfield, Illinois, United States

Countries

United States

Central Contacts

Rinad S Beidas, PhD

Role: CONTACT

Rinad.beidas@northwestern.edu

312-503-0546

Facility Contacts

Cheri Hoots Tabor, RN

Role: primary

choots@iphca.org

217-541-7413

Other Identifiers

FP00003311

Identifier Type: -

Identifier Source: org_study_id

R01NR021291

Identifier Type: NIH

Identifier Source: secondary_id

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