Safety Planning for Suicide Prevention

(HSI Trial)

Overseen By Shalomi Shelton

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Cognitive impairment, Opioid use, Alcohol use, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach, the Enhanced Lethal Means Safety Plan, designed to help Veterans at risk for suicide by limiting access to dangerous items like firearms and medications. The goal is to determine if this plan can enhance safety for these Veterans during visits to VA healthcare settings. Veterans who may qualify have recently visited a VA emergency room or clinic, have access to firearms or medications at home, and have shown signs of suicide risk. As an unphased trial, this study provides Veterans an opportunity to contribute to innovative safety strategies that could save lives.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this intervention is safe for Veterans with elevated suicide risk?

Research has shown that safety measures to limit access to harmful items are generally safe and well-received. For example, one study found that a safety program with the National Guard helped prevent injuries and suicides involving firearms. Another study demonstrated that regular counseling in emergency rooms reduced the risk of suicide in the short term, from 30 to 180 days. These measures aim to limit access to dangerous items like guns and medications, helping to prevent harm and save lives. They are voluntary and focus on the individual's needs, respecting their choices and comfort. Overall, evidence suggests these measures effectively lower the risk of suicide. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Lethal Means Safety Plan because it offers a proactive approach to suicide prevention. Unlike traditional treatments, which often focus on therapy or medication after a crisis, this method emphasizes preventing access to means of self-harm before a crisis occurs. This approach is particularly innovative as it aims to reduce immediate risk by addressing environmental factors, offering a potentially life-saving intervention that complements existing mental health treatments.

What evidence suggests that the Enhanced Lethal Means Safety Plan is effective for suicide prevention?

Research has shown that safety planning can help reduce suicidal thoughts and actions. Including advice on limiting access to dangerous items, such as guns, can significantly lower short-term suicide risk—by up to 35%. For instance, in Israel, a policy that reduced soldiers' access to firearms led to a 40% decrease in suicide rates. Counseling on safely storing or limiting access to lethal means can also prevent accidental gun deaths and injuries. These findings suggest that the Enhanced Lethal Means Safety Plan, the focus of this trial's intervention arm, could be a promising approach for veterans at risk of suicide. ^{2 3 5 6 7}

Who Is on the Research Team?

Joseph A Simonetti, MD MPH

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Are You a Good Fit for This Trial?

This trial is for Veterans over 17 years old who visited a VHA emergency department or urgent care, are at intermediate to high suicide risk, and have access to firearms or medications. They must be discharged home, willing to review a safety plan, and able to consent. Those with severe illness, intoxication issues, unreliable phone access, homelessness without an address, or daily substance abuse can't join.

Inclusion Criteria

Suicide risk is determined to be intermediate or high based on the CSRE results

Patient-reported access to firearms and/or medications

I was sent home after my emergency department visit.

Exclusion Criteria

I am able to understand and consent to my own medical treatment.

Unreliable telephone access

Those currently experiencing unsheltered homelessness

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive the lethal means safety intervention developed specifically for Veterans with elevated suicide risk

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in firearm and medication storage practices and beliefs about safety measures

4 weeks

2 optional visits (in-person)

Extended Follow-up

Verification of naloxone prescription and medication return envelope

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Lethal Means Safety Plan

Trial Overview The study tests an enhanced lethal means Safety Plan intervention designed for Veterans identified as having elevated suicide risk in emergency settings. It aims to reduce the risk of suicide by limiting access to methods like firearms and medications.

How Is the Trial Designed?

Group I: intervention arm Experimental Treatment 1 Intervention

There is a single intervention arm with no comparator for this pilot study

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

In a study of 32,658 psychiatric emergency service records from 15,652 patients, only 69.9% had any documentation of lethal means assessment, highlighting a significant gap in suicide risk evaluation.

Among the visits with documented access to lethal means, 59.6% did not specify the means available, indicating a need for improved documentation practices to enhance the effectiveness of suicide prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lethal Means Assessment in Psychiatric Emergency Services: Frequency and Characteristics of Assessment. Massey, AE., Borghesani, P., Stuber, J., et al.[2022]

The 'Lock to Live' decision aid for lethal means safety shows promise in helping emergency department clinicians counsel patients at risk of suicide, based on qualitative interviews with 15 clinicians.

Successful implementation of the tool depends on clinicians' perceptions of its utility, time constraints, and how well it fits into the existing emergency department workflow.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lethal means counseling for suicide prevention: Views of emergency department clinicians. Siry, BJ., Polzer, E., Omeragic, F., et al.[2022]

MYPLAN is a mobile application developed to help individuals at risk of suicide create personalized safety plans, making it more accessible than traditional paper versions.

Since its launch in 2013, MYPLAN has been positively received, with nearly 8,000 downloads in Denmark and Norway, indicating its potential utility in supporting at-risk individuals, especially among younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MYPLAN - A Mobile Phone Application for Supporting People at Risk of Suicide. Skovgaard Larsen, JL., Frandsen, H., Erlangsen, A.[2022]

Individuals with mental illness face a heightened risk of suicide, especially after being discharged from psychiatric hospitalization.

Safety planning intervention (SPI) has shown promising results in emergency departments, but there is a significant gap in research regarding its implementation during psychiatric hospitalization at discharge, indicating a need for more widespread use of SPI in this setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Planning: Why It Is Essential on the Day of Discharge From In-patient Psychiatric Hospitalization in Reducing Future Risks of Suicide. Schuster, H., Jones, N., Qadri, SF.[2023]

In a study of 1,602 veterans, 30% of safety plans for suicide prevention were missing social contacts for distraction or help, which is crucial during a crisis.

Notably, veterans without a help contact were over twice as likely to attempt suicide or die by suicide in the following year, highlighting the importance of including social support in safety plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictive Importance of Social Contacts on U.S. Veteran Suicide Safety Plans. Chalker, SA., Parrish, EM., Martinez Ceren, CS., et al.[2023]

Lethal means safety counseling (LMSC) is an important suicide prevention strategy that encourages patients to limit access to lethal means, such as firearms and medications, but it is underutilized in clinical practice due to various contextual factors.

A systematic review of 19 qualitative studies revealed key themes influencing LMSC implementation, including the cultural significance of firearms to owners, the need for providers to demonstrate cultural competency, and the importance of individualizing the counseling approach to enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stakeholder perceptions of lethal means safety counseling: A qualitative systematic review. Khazanov, GK., Keddem, S., Hoskins, K., et al.[2023]

Safety planning, including lethal means safety (LMS) counseling, is crucial for reducing suicide and violence risk by helping at-risk patients make safer firearm storage decisions.

The article provides a framework and evidence for effectively delivering LMS counseling, emphasizing the importance of individualized safety recommendations and proper documentation of these discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Risk Management and Firearm-related Lethal Means Safety. Simonetti, JA., Wortzel, HS., Matarazzo, BB.[2023]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

The Safety Planning Intervention (SPI) is a structured six-step action plan designed to help individuals at risk of suicide by enhancing their coping strategies and social support, and by removing access to means of self-harm.

Research shows that SPI is highly effective in reducing suicidal behavior, making it a valuable tool in various settings such as emergency rooms and outpatient clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[SAFETY PLANNING INTERVENTION FOR SUICIDE PREVENTION]. Perlstein, J., Katzir, N., Lotan, A., et al.[2022]

Veterans with psychosis who completed a safety plan were significantly more likely to experience psychiatric hospitalizations and emergency visits in the following year, indicating a higher level of crisis service use compared to those without psychosis.

Despite the increased need for crisis services, Veterans with psychosis did not show a corresponding increase in calls to the Veterans Crisis Line, suggesting a need for targeted interventions to improve their engagement with crisis resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Crisis service utilization following completion of a suicide safety plan for Veterans with and without affective and nonaffective psychosis. Chalker, SA., Parrish, EM., Martinez Ceren, CS., et al.[2023]

The suicide safety plan is a collaborative tool between clinicians and patients that outlines steps to take when experiencing suicidal urges, emphasizing its importance in clinical practice despite not being a treatment itself.

While the safety plan is beneficial for managing suicidal thoughts, there is a critical need for further research to develop effective treatments and prevention strategies for suicidality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching health care professionals about suicide safety planning. Sher, L., LaBode, V.[2022]

The implementation of a treatment escalation/limitation plan (TELP) alongside a do-not-attempt cardiopulmonary resuscitation order (DNACPR) significantly reduced the rates of harms, non-beneficial interventions, and clinical problems in patients who died in the hospital, compared to those with DNACPR only or neither plan.

In a study of 289 patients, those with a TELP/DNACPR experienced much lower incidences of adverse outcomes, with harms occurring at a rate of 17.1 per 1000 bed days compared to 76.9 for DNACPR only and 197.8 for those with neither, highlighting the effectiveness of TELP in managing end-of-life care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a treatment escalation/limitation plan on non-beneficial interventions and harms in patients during their last admission before in-hospital death, using the Structured Judgment Review Method. Lightbody, CJ., Campbell, JN., Herbison, GP., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10189833/

Effectiveness of Suicide Safety Planning Interventions Evidence across a range of studies indicates that SSP is effective for reducing suicide behavior (SB) and ideation (SI).

2. sciencedirect.com sciencedirect.com/science/article/pii/S2773065425000240

Evaluating the Effect of Routine Lethal Means Counseling ... An evaluation of safety planning, a comprehensive suite of intervention strategies that includes lethal means counseling, found a 35% reduction in the short- ...

3. health.mil health.mil/Military-Health-Topics/Centers-of-Excellence/Psychological-Health-Center-of-Excellence/Clinicians-Corner-Blog/Mental-Health-Stigma-and-Suicide-Risk/Lethal-Means-Safety-Interventions-for-Suicide-Prevention

Lethal Means Safety Interventions for Suicide Prevention Some research shows specific types of safety interventions for some suicide methods can probably reduce suicide. However, these findings are not ...

4. academic.oup.com academic.oup.com/epirev/article/46/1/1/7602966

A systematic review of lethal means safety counseling ... After a policy change that reduced firearm access among service members in the Israeli Defense Force, suicide rates decreased significantly by 40%.3 Studies ...

5. publichealth.jhu.edu publichealth.jhu.edu/center-for-gun-violence-solutions/lethal-means-safety-counseling

Lethal Means Safety Counseling | Center for Gun Violence ... Lethal means safety counseling can be used to help prevent suicides, homicides, unintentional gun deaths, and nonfatal firearm injuries. What Is Lethal Means ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39160836/

Evaluating a Lethal Means Safety Intervention to Reduce ... The purpose of this paper is to examine a scalable secure firearm storage intervention in the US National Guard (NG) in preventing firearm injury and suicide.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11557319/

Successful pilot implementation of mailing lethal means safety ... Lethal means safety (LMS) is an evidence-based intervention that reduces suicide risk by removing or reducing access to lethal means, putting ...