VA S.A.V.E. for Suicide Prevention

Overseen By Kaitlin M Leonard, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: No internet, Duplicate entry, Others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

710 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is VA S.A.V.E. training safe for participants?

The available research does not provide specific safety data for VA S.A.V.E. training, but it is a program designed to teach people how to help veterans at risk for suicide, and there are no reports of harm from participating in this training. ^{1 2 3 4 5}

Is the treatment VA S.A.V.E. a promising treatment for suicide prevention?

The information provided does not include any details about the VA S.A.V.E. treatment for suicide prevention. Therefore, I cannot determine if it is a promising treatment based on the given data. ^{6 7 8 9 10}

What is the purpose of this trial?

Veterans are most likely to disclose suicidal thoughts to their close supports such as family and friends. These loved ones are, in turn, very interested in learning how to help a Veteran in need. Close supports are uniquely poised to provide a meaningful contribution to suicide prevention, if they can learn how to effectively promote Veterans' connection to care. VA S.A.V.E. (Signs; Ask; Validate; Encourage and Expedite) is a suicide prevention gatekeeper training specifically tailored to the Veteran community that teaches close supports how to identify signs of suicide risk and how to connect the at-risk person to professional treatment. The primary objective of this study is to evaluate the effectiveness of VA S.A.V.E. and to explore factors impacting its potential widespread implementation.

Research Team

Alan R. Teo, MD MS

Principal Investigator

VA Portland Health Care System, Portland, OR

Eligibility Criteria

This trial is for individuals who are in regular contact with a Veteran at least once a week, such as family members, caregivers, or friends. Participants must have internet access and provide valid contact information. Those who have already taken VA S.A.V.E. training or plan to take it soon cannot join.

Inclusion Criteria

Social contact with a Veteran at least once a week

Family member, caregiver, or friend of a Veteran

Exclusion Criteria

No internet access

Indication of duplicate study entry

I have completed or plan to complete VA S.A.V.E. training soon.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive VA S.A.V.E. training or watch an informational video as a control

1 session

1 visit (virtual)

Follow-up

Participants are monitored for the use of gatekeeper behaviors and suicide prevention skills

12 months

Surveys conducted at 3-month and 6-month intervals

Treatment Details

Interventions

• VA S.A.V.E.

Trial Overview The study is testing the effectiveness of VA S.A.V.E., a suicide prevention program designed for the Veteran community. It compares how well people can help Veterans at risk of suicide after receiving this specific training versus standard control training.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

VA S.A.V.E. Training

Group II: Control Placebo Group 1 Intervention

Myths and Facts of Wounded Warriors

VA S.A.V.E. is already approved in United States for the following indications:

Approved in United States as VA S.A.V.E. for:

• Suicide prevention

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 VA S.A.V.E. gatekeeper training program was successfully implemented in a remote trial with 214 participants, primarily spouses or partners of veterans, demonstrating feasibility in recruiting and retaining participants over six months.

While the study met most feasibility benchmarks, challenges such as generic advertising and the platform used for recruitment were identified, alongside effective strategies like targeting veterans' family members and emphasizing the urgency of the training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of recruitment and retention in a remote trial of gatekeeper training for close supports of military veterans: Mixed methods study. Teo, AR., Call, AA., Hooker, ER., et al.[2023]

In a pilot study involving 214 participants, the VA S.A.V.E. training significantly increased the use of gatekeeper behaviors for suicide prevention among veterans, with 66.7% to 84.9% of participants engaging in these behaviors compared to 44.4% to 77.1% in the control group.

Participants who completed the VA S.A.V.E. training reported high satisfaction and usability, indicating that the training is well-received and may lead to positive behavior changes in identifying and assisting veterans at risk for suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief video training for suicide prevention in veterans: A randomized controlled trial of VA S.A.V.E. Teo, AR., Hooker, ER., Call, AA., et al.[2023]

The SAFE VET protocol aims to test a brief intervention that combines Safety Planning Intervention with structured follow-up to effectively reduce suicide risk among Veterans in emergency departments.

This study addresses a significant gap in evidence-based interventions for Veterans at risk of suicide, focusing on enhancing their engagement in outpatient behavioral health treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and study protocol for a two-part intervention: Safety planning and structured follow-up among veterans at risk for suicide and discharged from the emergency department. Currier, GW., Brown, GK., Brenner, LA., et al.[2022]

A comprehensive analysis of adverse events in Veterans Health Administration mental health units revealed 87 root cause analysis reports and 9780 safety reports, highlighting a significant risk of various incidents, including 31 suicide attempts and 16 elopements.

Falls were the most frequently reported safety event, followed by medication errors and assaults, indicating that a broad approach to patient safety is essential in mental health settings, similar to medical units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events occurring on mental health units. Mills, PD., Watts, BV., Shiner, B., et al.[2018]

The analysis of adverse events and near misses is crucial for improving patient safety, highlighting the importance of understanding the root causes of these incidents.

The diverse perspectives of participants in safety discussions can enhance the effectiveness of safety initiatives, as demonstrated by the VA Center for Patient Safety's leadership in the safety movement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative patient safety program launched. [2004]

In a study of 31 patients with ruptured sinus of Valsalva aneurysm, a new surgical technique using patches for repair resulted in no recurrent ruptures or residual defects, demonstrating its efficacy and safety.

After surgery, 85% of the surviving patients were in the best functional class (NYHA Class I) at follow-up, with a long-term survival rate of 85.6% over 25 years, indicating excellent outcomes from this surgical approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical repair and long-term results in ruptured sinus of Valsalva aneurysm. Abe, T., Komatsu, S.[2022]

An 18-year-old female with a ruptured sinus of Valsalva aneurysm experienced cardiac tamponade, highlighting the critical need for immediate diagnosis and treatment of this rare condition.

The successful semi-urgent surgical resection of the aneurysm demonstrates that off-pump surgery can be a viable option in certain cases, providing a safe approach to managing this life-threatening anomaly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac tamponade due to a ruptured aneurysm of the sinus of valsalva. Weijerse, A., van der Schoot, MJ., Maat, LP., et al.[2008]

A new and simpler classification system for sinus of Valsalva aneurysms (SVAs) was developed, categorizing them into four types based on their rupture or protrusion locations, which could enhance surgical decision-making.

Surgical repair of SVAs showed excellent outcomes with no early postoperative deaths and good long-term recovery, indicating the safety and efficacy of the proposed surgical approaches for each SVA type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new and simple classification for sinus of Valsalva aneurysms and the corresponding surgical procedure. Guo, HW., Xiong, H., Xu, JP., et al.[2013]

A 67-year-old female patient experienced a life-threatening cardiac tamponade due to a ruptured sinus of Valsalva aneurysm, leading to intrapericardial bleeding.

Despite undergoing surgical intervention, the patient unfortunately did not survive, highlighting the critical nature of timely treatment for such conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ruptured aneurysm of the left sinus of Valsalva into the pericardium. Doevendans, PA., Geskes, GG., van Aarnhem, G., et al.[2020]

A 23-year-old patient with a ruptured sinus of Valsalva aneurysm (SVA) presented with severe symptoms, including chest pain and shortness of breath, highlighting the importance of recognizing this rare but serious condition that can remain asymptomatic until rupture.

Echocardiography is crucial for diagnosing a ruptured SVA, and emergency surgical repair can lead to excellent outcomes, emphasizing the need for prompt intervention in such cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute rupture of a sinus of Valsalva aneurysm into the right atrium: a case report and a narrative review. Doost, A., Craig, JA., Soh, SY.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Feasibility of recruitment and retention in a remote trial of gatekeeper training for close supports of military veterans: Mixed methods study. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Brief video training for suicide prevention in veterans: A randomized controlled trial of VA S.A.V.E. [2023]

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

Rationale and study protocol for a two-part intervention: Safety planning and structured follow-up among veterans at risk for suicide and discharged from the emergency department. [2022]

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

Adverse events occurring on mental health units. [2018]

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

Collaborative patient safety program launched. [2004]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Surgical repair and long-term results in ruptured sinus of Valsalva aneurysm. [2022]

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

Cardiac tamponade due to a ruptured aneurysm of the sinus of valsalva. [2008]

8. Germany pubmed.ncbi.nlm.nih.gov

A new and simple classification for sinus of Valsalva aneurysms and the corresponding surgical procedure. [2013]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Ruptured aneurysm of the left sinus of Valsalva into the pericardium. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Acute rupture of a sinus of Valsalva aneurysm into the right atrium: a case report and a narrative review. [2020]