This trial is active, not recruiting.

Condition suicide risk | patient
Treatment safe vet
Sponsor VA Eastern Colorado Health Care System
Collaborator VA Office of Research and Development
Start date September 2009
End date December 2016
Trial size 600 participants
Trial identifier NCT01334541, W81XWH-09-2-0129-1


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
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

Primary Outcomes

Columbia Suicide-Severity Rating Scale (C-SSRS; Posner et al., 2006; Posner et al. 2008).
time frame: Baseline and 1, 3, and 6 month follow-up assessments

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 89 years old.

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.

Additional Information

Official title A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans- Study 1
Principal investigator Marjan Holloway, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by VA Eastern Colorado Health Care System.