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

30 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Enhanced Lethal Means Safety Plan for suicide prevention?

Research shows that safety planning, which includes removing dangerous means for suicide, is highly effective in lowering suicidal behavior. This approach is used in various settings and has shown promising results in reducing suicide risk, especially when combined with other supportive strategies. ^{1 2 3 4 5}

Is the Enhanced Lethal Means Safety Plan safe for humans?

The Enhanced Lethal Means Safety Plan, which involves counseling to reduce access to firearms and medications, is generally considered safe as it focuses on making the environment safer for individuals at risk of suicide. It is a recommended strategy in emergency settings and involves voluntary changes in behavior. ^{1 6 7 8 9}

How is the Enhanced Lethal Means Safety Plan treatment different from other suicide prevention treatments?

The Enhanced Lethal Means Safety Plan is unique because it focuses on reducing access to means of self-harm, which is a proven strategy at the population level, but less understood on an individual level. Unlike traditional treatments, it emphasizes creating a personalized plan to limit access to lethal means, which can be more effective in preventing impulsive suicidal actions. ^{6 8 10 11 12}

What is the purpose of this trial?

Access to lethal methods of self-harm such as firearms and medications increases risk for suicide. As such, VA/DoD guidelines for the care of individuals with elevated suicide risk include recommendations that clinicians deliver interventions to reduce access to lethal methods of suicide among patients who are identified as having elevated suicide risk. However, no interventions have been developed or tested among Veterans with elevated suicide risk. The aim of this study is to pilot test a lethal means safety intervention developed specifically for Veterans who seek care in VHA clinical settings and are identified as having elevated suicide risk.

Research Team

Joseph A Simonetti, MD MPH

Principal Investigator

Rocky Mountain Regional VA Medical Center, Aurora, CO

Eligibility Criteria

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

Patient-reported access to firearms and/or medications

I was sent home after my emergency department visit.

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

Exclusion Criteria

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

Unreliable telephone access

Those currently experiencing unsheltered homelessness

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Lethal means counseling for suicide prevention: Views of emergency department clinicians. [2022]

2. England 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. [2023]

3. Israel pubmed.ncbi.nlm.nih.gov

[SAFETY PLANNING INTERVENTION FOR SUICIDE PREVENTION]. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Crisis service utilization following completion of a suicide safety plan for Veterans with and without affective and nonaffective psychosis. [2023]

5. United States 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. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Lethal Means Assessment in Psychiatric Emergency Services: Frequency and Characteristics of Assessment. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Therapeutic Risk Management and Firearm-related Lethal Means Safety. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Predictive Importance of Social Contacts on U.S. Veteran Suicide Safety Plans. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Stakeholder perceptions of lethal means safety counseling: A qualitative systematic review. [2023]

10. Canada pubmed.ncbi.nlm.nih.gov

MYPLAN - A Mobile Phone Application for Supporting People at Risk of Suicide. [2022]

11. Croatia pubmed.ncbi.nlm.nih.gov

Teaching health care professionals about suicide safety planning. [2022]

12. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]