Scaling Out S.A.F.E. Firearm Across Two Health Systems as a Universal Suicide Prevention Strategy (SCALE ASPIRE)

NCT07009314 | Not Yet Recruiting DMC

• 2 other identifiers: AWD00002547R01MH138333
• Study Type: interventional
• Target: 5,442
• Locations: 1 country
• Sites: 2

Brief Summary

In this randomized controlled trial, researchers will assess the expansion of the S.A.F.E. Firearm program into adult primary care and women's health at two health systems in Michigan and Colorado that have previously implemented S.A.F.E. Firearm in pediatrics. S.A.F.E. Firearm involves a brief conversation between health care staff and patients about secure firearm storage and an offer of a free firearm cable lock. Researchers will test S.A.F.E. Firearm and a package of strategies intended to help health care staff incorporate the program into their practice. The strategies include: training, a prompt in the electronic health record, and facilitation, or tailored problem-solving support. The study seeks to answer the following questions:

• How effective is S.A.F.E. Firearm at changing patients' firearm storage behavior?
• How effective is the implementation strategy package at increasing delivery of the S.A.F.E. Firearm program? Some patients and health care staff will be invited to participate in surveys and/or interviews about their experiences with S.A.F.E. Firearm and the implementation strategy package.

Conditions

Suicide

Keywords

implementation science; firearms; suicide

Outcome Measures

Primary Outcomes (2)

• Firearm storage behavior

  Patients who indicate that there are firearms in or around their homes will be asked to report their firearm storage practices in (a) the 2 weeks prior to the visit; and (b) the 2 weeks after the visit. Respondents will indicate whether none, some, or all firearms were stored locked at each time point. Locked storage refers to storage in a container that limits access to the firearm (e.g., safe, cabinet, case) and/or storage with a cable or trigger lock.

  Firearm storage behavior will be collected via survey sent to patients after visits for the 3-year study period (baseline through maintenance phases)

• Patient-reported reach of the S.A.F.E. Firearm program

  The proportion of eligible visits for which patients report receiving the two components of S.A.F.E. Firearm (discussion of secure firearm storage, offer of a free cable firearm lock)

  Reach will be collected via survey sent to patients after visits for the 3-year study period (baseline through maintenance phases)

Study Arms (3)

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

EXPERIMENTAL

Each group of clinics will cross over from the baseline phase to the implementation phase, one at a time. In the implementation phase, the implementation approaches (training, EHR nudge, facilitation) and the S.A.F.E. Firearm program will be implemented. S.A.F.E. Firearm consists of health care staff having a secure firearm storage discussion with a patient during their visit and offering them a free cable firearm lock. The implementation phase will last for 6 months for each group of clinics.

Behavioral: Implementation package (training, facilitation, electronic health record nudge)

Baseline data collection phase (usual care)

NO INTERVENTION

The study will begin with a baseline data collection phase. During the baseline data collection phase, no clinics will be exposed to S.A.F.E. Firearm nor the implementation approaches (training, EHR nudge, facilitation). 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 clinics will be in the baseline data collection phase for at least six months before the interventions are activated.

Maintenance phase (training and facilitation removed)

NO INTERVENTION

After the six-month period during which the implementation strategies (training, EHR nudge, facilitation) are enacted at a clinic, the research team will assess outcomes during the remainder of the study period in a "maintenance" phase. No additional training or facilitation will be received during this maintenance period following the implementation period. Clinics will still receive ongoing data reports, the the EHR nudge will remain turned on, and clinics will continue to deliver the S.A.F.E. Firearm program.

Interventions

Implementation package (training, facilitation, electronic health record nudge) BEHAVIORAL

Training will consist of an initial presentation on S.A.F.E. Firearm by the study team, informational resources to support program delivery, and recommendations for self-guided continuing medical education programs. Facilitation will last 6 months at each site. It may involve 1) a readiness assessment for each clinic to identify implementation barriers and develop relationships with constituents; 2) kick-off meetings at trial launch, at which staff will identify how to implement S.A.F.E. Firearm in 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 the program for future years. A clinician decision support ("nudge"), designed to align with best practices within each health system, will be deployed in the EHR workflow to remind clinicians to deliver S.A.F.E. Firearm and offer a cable lock.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be 18+ years of age and attend an eligible visit within a participating specialty (adult primary care, women's health) at a participating clinic within the Henry Ford Health or Kaiser Permanente Colorado health systems
• Health care personnel must be 18+ years of age and employed by a participating health care clinic within the Henry Ford Health or Kaiser Permanente Colorado health systems

You may not qualify if:

• None

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Mental Health (NIMH): collaborator
• Henry Ford Health System: collaborator
• Kaiser Permanente: collaborator
• Michigan State University: collaborator

Study Sites (2)

Kaiser Permanente Colorado

Aurora, Colorado, 80014, United States

Location

Henry Ford Health

Detroit, Michigan, 48202, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Rinad S Beidas, PhD

CONTACT

312-503-0546; Rinad.beidas@northwestern.edu

Daniel Blumenthal

CONTACT

daniel.blumenthal@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data analyst and biostatistician will be blinded to randomization assignment.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ralph Seal Paffenbarger Professor and Chair, Department of Medical Social Sciences

Model Details: Stepped wedge randomized controlled trial

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: June 6, 2025

Record last verified: 2025-05

Locations

US (2)