A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans- Study 1

Suicide Risk | Patient Clinical Trial

— SAFE VET  

Official title:

A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans- Study 1

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01334541
• Other study ID #: W81XWH-09-2-0129-1
• Status: Completed
• Start date: September 2009
• Est. completion date: December 2018

Study information

• Verified date: October 2018
• Source: VA Eastern Colorado Health Care System
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators propose to evaluate Suicide Assessment and Follow-up Engagement: Veteran Emergency Treatment (SAFE VET) which is currently being implemented in 4 VA ED/Urgent Care Units across the United States (Portland VA Medical Center (VAMC), Denver VAMC, Manhattan VAMC, and Philadelphia VAMC).

Description:

Background: In 2009, a novel clinical demonstration project entitled Suicide Assessment and Follow-up Engagement: Veteran Emergency Treatment (SAFE VET) was initiated as a potential standard of care for suicidal Veterans who receive treatment at Veterans Affairs (VA) emergency departments (ED). SAFE VET is designed to attenuate suicide risk by helping Veterans manage suicidal thoughts and behaviors, and adhere to prescribed clinical care; thereby promoting resiliency and increased capacity to cope with suicidal states.

Objectives: Using a quasi-experimental design, the aim of this study is to compare the effectiveness of the SAFE VET intervention versus enhanced usual care (E-CARE)on the following: 1) the proportion of patients who attempt suicide within 6 months of index emergency department (ED) visit; 2) the severity of suicide ideation within 6 months after index ED visit; 3) the proportion of patients who attend > 1 outpatient mental health or substance abuse treatment appointments within 30 days following index ED visit; and 4) the degree of suicide-related coping for attending treatment during the 6 month period.

Methodology: Six hundred Veterans, up to 300 per condition (SAFE VET or E-CARE), who meet inclusion/exclusion criteria will be enrolled. E-CARE sites are as follows: Long Beach VAMC, Bronx VAMC, Milwaukee VAMC, and San Diego VAMC. All subjects will participate in an approximately 1-hour long baseline assessment battery (index ED visit) by phone, and will be contacted by phone at approximately 1, 3, and 6 months after the index ED visit to complete follow-up measures. Medical records will also be reviewed to determine VA health service usage in the six-month period after study enrollment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

Veterans will be enrolled who:

1. have received the SAFE VET intervention in VA SAFE VET EDs or treatment-as-usual in E-CARE EDs;

2. aged 18 years or older;

3. identified as being at risk for suicide based upon presenting complaints and/or the assessment of an ED clinician;

4. able to provide 2 contacts with telephone numbers for tracking purposes; and

5. able to provide a home/residential/shelter address where the participant resides and either a home, cellular, or other telephone number where the participant can be reached.

Exclusion Criteria:

Veterans will not be enrolled if they are:

1. unable to read and understand English;

2. unable or unwilling to give informed consent as determined either by the referring VA ED clinical staff or research personnel (see Mini Quiz below); and/or

3. admitted to the VA inpatient psychiatric unit from the ED.

Related Conditions & MeSH terms

• Suicide
• Suicide Risk | Patient

Intervention

Behavioral:
• SAFE VET
All SAFE VET EDs provide a standardized intervention that is specifically adapted for use in the ED to mitigate suicide risk. Given that the SAFE VET intervention was developed for use in a busy ED setting, the length of the intervention is approximately 45 minutes. The SAFE VET intervention is administered by a clinical provider who has been specifically trained and consists of: Risk Assessment Safety Planning Intervention: Developed by Stanley and Brown (2008), Safety Planning Intervention consists of a hierarchically-arranged list of coping strategies identified for use during a subsequent suicidal crisis. Clinical Follow-Up Protocol

Locations

Country	Name	City	State
United States	Bronx VAMC	Bronx	New York
United States	Denver VAMC	Denver	Colorado
United States	Long Beach VAMC	Long Beach	California
United States	Manhattan VAMC	Manhattan	New York
United States	Milwaukee VAMC	Milwaukee	Wisconsin
United States	Philadelphia VAMC	Philadelphia	Pennsylvania
United States	Portland VAMC	Portland	Oregon
United States	San Diego VAMC	San Diego	California

Sponsors (6)

Lead Sponsor	Collaborator
VA Eastern Colorado Health Care System	Columbia University, Uniformed Services University of the Health Sciences, United States Department of Defense, University of Pennsylvania, US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Columbia Suicide-Severity Rating Scale (C-SSRS; Posner et al., 2006; Posner et al. 2008).		Baseline and 1, 3, and 6 month follow-up assessments
Secondary	Scale for Suicide Ideation (SSI; Beck, Kovacs, & Weissman, 1979).		Baseline and 1, 3, and 6 month follow-up assessments