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

Northwestern University

Status: Not yet enrolling

Conditions: Suicide

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07009314

AWD00002547

R01MH138333 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,442 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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5,442 participants in 3 patient groups

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

Experimental group

Description:

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.

Treatment:

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

Baseline data collection phase (usual care)

No Intervention group

Description:

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 group

Description:

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.