SuicideNCT07009314
Scaling Out S.A.F.E. Firearm Across Two Health Systems as a Universal Suicide Prevention Strategy (SCALE ASPIRE)
A study testing Implementation package (training, facilitation, electronic health record nudge) in people with Suicide, run by Northwestern University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide
- What is being tested?
- Implementation package (training, facilitation, electronic health record nudge)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,442 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2027to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Daniel Blumenthal contact
United States2 sites
Kaiser Permanente Colorado
Aurora, Colorado, 80014
Jennifer M Boggs, PhD, 720-355-7278, Jennifer.M.Boggs@kp.org
Jennifer M Boggs, PhD
Henry Ford Health
Detroit, Michigan, 48202
Brian Ahmedani, PhD, 313-874-5454, BAHMEDA1@hfhs.org
Brian K Ahmedani, PhD
About this study
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:
Read more
- 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.
Read the 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, 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, the researchers 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.
- Conditions
- Suicide
- Being tested
- Implementation package (training, facilitation, electronic health record nudge)
- Keywords
- implementation science, firearms, suicide
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation package (training, facilitation, electronic health record nudge)Behavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: Reach will be collected via survey sent to patients after visits for the 3-year study period (baseline through maintenance phases)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study startJan 2027 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped wedge randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 5,442 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Henry Ford Health System, Kaiser Permanente, Michigan State University
- Responsible party
- Principal investigator, Rinad Beidas, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009314
- Sponsor's protocol ID
- AWD00002547
- Other IDs
- R01MH138333
- Status last verified
- Apr 2026
- First submitted
- 29 May 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling Out S.A.F.E. Firearm Across Two Health Systems as a Universal Suicide Prevention Strategy (SCALE ASPIRE)
- ClinicalTrials.gov ID
- NCT07009314
- Acronym / sponsor ID
- AWD00002547
- Conditions
- Suicide
- Keywords
- implementation science, firearms, suicide
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,442 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Henry Ford Health System, Kaiser Permanente, Michigan State University
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, 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, the researchers 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Stepped wedge randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Implementation phase (training, EHR nudge, and facilitation received; S.A.F.E. Firearm delivered) | Experimental | Behavioral: Implementation package (training, facilitation, electronic health record nudge)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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation package (training, facilitation, electronic health record nudge)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. | Behavioural | Implementation phase (training, EHR nudge, and facilitation received; S.A.F.E. Firearm delivered) |
Primary outcome
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)
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.
Patient-reported reach of the S.A.F.E. Firearm program
Time frame: Reach will be collected via survey sent to patients after visits for the 3-year study period (baseline through maintenance phases)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel Blumenthal contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation package (training, facilitation, electronic health record nudge) in people with Suicide, run by Northwestern University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rinad S Beidas, PhD (312-503-0546, Rinad.beidas@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.