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

ConditionSuicide
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

5,442 Participants
are divided into 3 treatment groups
Group A: Implementation phase (training, EHR nudge, and facilitation received; S.A.F.E. Firearm delivered)Experimental treatment 1 intervention
Group B: Baseline data collection phase (usual care)No intervention 0 interventions
Group C: Maintenance phase (training and facilitation removed)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

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)
2

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)

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Northwestern University

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Henry Ford Health System

Collaborator

Kaiser Permanente

Collaborator

Michigan State University

Collaborator

This trial is not recruiting at the moment. You can still explore other options: