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

Completed

• Conditions: Suicide Risk | Patient
• Interventions: Behavioral: SAFE VET

• Registration Number: NCT01334541
• Lead Sponsor: VA Eastern Colorado Health Care System

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2011-04-11
• Study First Submitted QC: 2011-04-12
• Study First Posted: 2011-04-13
• Status Verified: 2018-10
• Primary Completion: 2018-11
• Study Completion: 2018-12
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SAFE VET	SAFE VET	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Scale for Suicide Ideation (SSI; Beck, Kovacs, & Weissman, 1979).	Baseline and 1, 3, and 6 month follow-up assessments

Trial Locations

Locations (8)

Manhattan VAMC; 🇺🇸 Manhattan, New York, United States

Portland VAMC; 🇺🇸 Portland, Oregon, United States

Long Beach VAMC; 🇺🇸 Long Beach, California, United States

Milwaukee VAMC; 🇺🇸 Milwaukee, Wisconsin, United States

Denver VAMC; 🇺🇸 Denver, Colorado, United States

Bronx VAMC; 🇺🇸 Bronx, New York, United States

San Diego VAMC; 🇺🇸 San Diego, California, United States

Philadelphia VAMC; 🇺🇸 Philadelphia, Pennsylvania, United States