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

Conditions

• Suicide

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Jan 31, 2026

Status verified

May 2025

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

5,442 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Implementation phase (training, EHR nudge, and facilitation received; S.A.F.E. Firearm delivered)
  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.
• No Intervention: Baseline data collection phase (usual care)
  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.
• No Intervention: Maintenance phase (training and facilitation removed)
  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.

Primary Outcome Measure

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

Central Contacts

• Rinad S Beidas, PhD
  312-503-0546
  [email protected]
• Daniel Blumenthal
  [email protected]

Locations (2)

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