Clinical trial NCT07009314: Scaling Out S.A.F.E. Firearm Across Two Health Systems as a Universal Suicide Prevention Strategy (SCALE ASPIRE)
Official title: Scaling Out S.A.F.E. Firearm Across Two Health Systems as a Universal Suicide Prevention Strategy (SCALE ASPIRE)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide
Keywords: implementation science
firearms
suicide
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Henry Ford Health System
name: Kaiser Permanente
name: Michigan State University
First posted: 2025-06-06
Enrollment: 5442
Sex: ALL
Minimum age (years): 18
Standard ages: 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: 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.

Detailed description: Reducing unauthorized access to firearms is a population-level suicide prevention strategy. S.A.F.E. Firearm is a universal evidence-based suicide prevention intervention primed for implementation nationally. In the largest hybrid type III effectiveness-implementation trial of its kind, funded by the National Institute of Mental Health (NIMH; "ASPIRE" trial), we tested how to implement S.A.F.E. Firearm across approximately 45,000 well-child visits in 30 pediatric primary care clinics at Henry Ford Health (HFH) in Michigan and Kaiser Permanente Colorado (KPCO). We found that training, an electronic health record (EHR)-based clinician decision support ("nudge"), and facilitation (i.e., implementation support to clinics) resulted in robust practice change from approximately 2% reach (baseline) to 49% reach (active implementation). While the ASPIRE trial focused on delivery of the intervention to parents of young people, we have the rare opportunity to expand S.A.F.E. Firearm delivery for all adults via adult primary care and women's health clinics, offering a new context and broadened population. This holds promise given that (a) many of these patients will have children in their homes (e.g., parents, grandparents) and (b) adults may benefit from S.A.F.E. Firearm themselves because putting time and space between adults and loaded firearms can reduce firearm suicide.

The proposed study ("SCALE-ASPIRE") is motivated by HFH and KPCO constituents' eagerness to implement this intervention beyond pediatric primary care and will advance the science of implementation by understanding how to "scale-out" successful intervention and implementation efforts. In SCALE-ASPIRE, we will conduct a stepped wedge cluster randomized hybrid type II effectiveness-implementation trial in approximately 48 clinics in adult primary care and women's health at HFH and KPCO. In Aim 1, in collaboration with key partners including clinicians, leaders, and patients, we will use the ADAPT-ITT approach to adapt S.A.F.E. Firearm for the new clinic context and broadened population. In Aim 2, we will test the effectiveness of S.A.F.E. Firearm and our implementation approach (training, EHR nudge, facilitation) on effectiveness (firearm storage behavior, co-primary; suicide attempts, suicide deaths, and all-cause firearm injury and mortality in adults and young people, secondary) and implementation (reach, or patient-reported receipt of S.A.F.E. Firearm, co-primary; implementation fidelity and cost, secondary) outcomes. In Aim 3, we will use mixed methods to elucidate intervention and implementation mechanisms and to better understand heterogeneity across levels. Specifically, we will conduct interviews to understand constituent perspectives, and explore how patient, clinician, and clinic factors relate to heterogeneity in our co-primary outcomes. Study results will guide the identification of effective secure firearm storage interventions, increase knowledge of effective implementation strategies in large health systems, and advance the literature on scaling out successful intervention and implementation efforts to new populations and settings.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* None

Primary outcomes:
measure: Firearm storage behavior
timeFrame: Firearm storage behavior will be collected via survey sent to patients after visits for the 3-year study period (baseline through maintenance phases)
measure: Patient-reported reach of the S.A.F.E. Firearm program
timeFrame: 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:
Locations:
city: Aurora
country: United States
facility: Kaiser Permanente Colorado
state: Colorado
city: Detroit
country: United States
facility: Henry Ford Health
state: Michigan
Study officials:
References: