S.A.F.E. Firearm Program for Suicide Prevention

Not yet recruiting at 1 trial location

Overseen By Daniel Blumenthal

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a program called S.A.F.E. Firearm in promoting safe firearm storage. The program includes a conversation with healthcare staff about secure storage and provides a free firearm lock. Researchers aim to determine if adding training and reminders for healthcare workers increases the program's usage. Individuals visiting adult primary care or women's health clinics in Michigan or Colorado, who have access to firearms, may be suitable for this trial. Participants might also share their experiences through surveys or interviews. As an unphased trial, this study offers participants the chance to contribute to important research that could enhance community safety.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on firearm safety and does not mention medication changes.

What prior data suggests that the S.A.F.E. Firearm program is safe for implementation in adult primary care and women's health?

Research has shown that the S.A.F.E. Firearm program, which discusses safe gun storage and distributes free cable locks, is generally safe. A study on a similar program found that distributing safe storage devices is feasible and well-received. This indicates that people are open to the idea, and it can be implemented without major issues.

The S.A.F.E. Firearm program emphasizes promoting safe storage practices rather than using medicine or medical procedures, eliminating concerns about medical side effects. The program aims to encourage safer gun storage, which can help reduce the risk of gun-related injuries or deaths.

Current evidence indicates that the program is well-received, with no reports of negative effects. Participants in similar programs have generally responded positively to discussions about gun safety and the offer of cable locks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the S.A.F.E. Firearm Program for suicide prevention because it introduces an innovative approach to reducing suicide risk by incorporating secure firearm storage discussions into regular healthcare visits. Unlike traditional mental health treatments, which often focus on therapy or medication, this program directly addresses the means of suicide by offering patients a free cable firearm lock and engaging them in a conversation about safe storage. By integrating these discussions and tools into the healthcare setting, the program aims to make an immediate impact on reducing the risk of firearm-related suicides. This method reflects a proactive, preventive strategy that is distinct from conventional treatment approaches.

What evidence suggests that the S.A.F.E. Firearm program and implementation package could be effective for suicide prevention?

Research has shown that storing guns safely can prevent unauthorized access, potentially lowering the risk of injury or death. Guns are the most lethal method in suicide attempts, often resulting in death. Safe storage practices, such as locking and unloading guns, might reduce these risks, although some studies have not directly linked these practices to lower suicide rates. In this trial, the S.A.F.E. Firearm program, part of the implementation phase, encourages safe storage by having healthcare staff discuss secure storage with patients and provide free gun locks. This approach aims to facilitate the adoption of safer habits and reduce potential harm. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adult patients and healthcare staff in Michigan and Colorado. It's focused on those involved with primary care or women's health where the S.A.F.E. Firearm program, promoting secure firearm storage, has not yet been implemented.

Inclusion Criteria

I am over 18 and visit a participating clinic for care.

I am over 18 and work at a clinic within Henry Ford Health or Kaiser Permanente Colorado.

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Baseline Data Collection

Clinics collect baseline data without exposure to S.A.F.E. Firearm or implementation approaches

At least 6 months

Implementation

Implementation of S.A.F.E. Firearm with training, EHR nudge, and facilitation

6 months

Regular clinic visits with S.A.F.E. Firearm discussions

Maintenance

Assessment of outcomes with ongoing data reports and EHR nudge, but no additional training or facilitation

Remainder of the study period

Follow-up

Participants are monitored for changes in firearm storage behavior and program reach

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Implementation package

Trial Overview The effectiveness of the S.A.F.E. Firearm program is being tested along with a support package to help staff integrate it into their practice. This includes training, electronic health record prompts, and problem-solving support.

How Is the Trial Designed?

Group I: Implementation phase (training, EHR nudge, and facilitation received; S.A.F.E. Firearm delivered) Experimental Treatment 1 Intervention

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.

Group II: Maintenance phase (training and facilitation removed) Active Control 1 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.

Group III: Baseline data collection phase (usual care) Active Control 1 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.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Michigan State University

Collaborator

Trials

202

Recruited

687,000+

Henry Ford Health System

Collaborator

Trials

334

Recruited

2,197,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12465913/

Opportunities and barriers to engaging caregivers in firearm ... Firearms are by far the most lethal method used in suicide attempts, with 9 out of 10 attempts resulting in death [7]. Storing firearms loaded ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836043

Firearm Storage and Firearm Suicide | Public Health In this case-control study, neither locking nor unloading household firearms was associated with whether adults used a firearm in their suicide.

3. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7323a1.htm

Firearm Storage Behaviors — Behavioral Risk Factor... Secure firearm storage might help reduce access by children and other unauthorized users and the related risk for injury or death. Information ...

4. academic.oup.com academic.oup.com/milmed/article/189/Supplement_3/510/7735924

Project Safe Guard: Evaluating a Lethal Means Safety ... Specifically, outcomes assessed included personal knowledge, attitudes, and behaviors related to firearm suicide and secure firearm storage, ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2451865425001231

Project Safe Guard–Trauma (PSG-T) When firearms are stored in a non-secure manner (e.g., unlocked, loaded), risk for suicide may be elevated. Accordingly, clinical, public health, and firearm ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11409402/

Evaluation of a Firearm Safe Storage Device Distribution ... This study assesses the feasibility and acceptability of a Firearm Safe Storage Device Distribution Program.

7. childrenshospitals.org childrenshospitals.org/news/cha-blog/2025/04/safe-firearm-storage-saves-lives

Safe Firearm Storage Saves Lives Studies show that secure, separate storage of firearms and ammunition is associated with a 78% decreased risk of self-inflicted gun injuries.

8. injepijournal.biomedcentral.com injepijournal.biomedcentral.com/articles/10.1186/s40621-024-00541-1

Impact of cable lock distribution on firearm securement after ... Securement of firearms and ammunition is associated with an almost 80% decrease in the odds of death from firearm-related suicide as well as 85% ...

9. gao.gov gao.gov/products/gao-17-665

Personal Firearms: Programs that Promote Safe Storage ... We identified 16 public or nonprofit programs that promote safe gun storage to help keep those guns away from kids and people at risk of suicide.