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

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).

Study Overview

• Status: Completed
• Conditions: Suicide Risk | Patient
• Intervention / Treatment: Behavioral: SAFE VET

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 Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• United States
  • California
    • Long Beach, California, United States, 90822
      • Long Beach VAMC
    • San Diego, California, United States, 92161
      • San Diego VAMC
  • Colorado
    • Denver, Colorado, United States, 80220
      • Denver VAMC
  • New York
    • Bronx, New York, United States, 10468
      • Bronx VAMC
    • Manhattan, New York, United States, 10010
      • Manhattan VAMC
  • Oregon
    • Portland, Oregon, United States, 97239
      • Portland Vamc
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia Vamc
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53295
      • Milwaukee VAMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Veterans who were seen in a VA Emergency Department and were identified as being at risk for suicide.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SAFE VET	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
E-CARE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: VA Eastern Colorado Health Care System
• Collaborators: University of Pennsylvania; Columbia University; United States Department of Defense; US Department of Veterans Affairs; Uniformed Services University of the Health Sciences
• Investigators: Principal Investigator: Marjan Holloway, Ph.D., Uniformed Services University of the Health Sciences; Principal Investigator: Gregory Brown, Ph.D., University of Pennsylvania; Principal Investigator: Lisa Brenner, Ph.D., Denver VAMC, VISN 19 MIRECC; Principal Investigator: Barbara Stanley, Ph.D., Columbia University; Principal Investigator: Kerry Knox, Ph.D., Canadaigua VAMC- Center of Excellence; Principal Investigator: Glenn Currier, M.D., Canandaigua VAMC- Center of Excellence

Publications and helpful links

General Publications

• Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.
• Matarazzo BB, Brown GK, Stanley B, Forster JE, Billera M, Currier GW, Ghahramanlou-Holloway M, Brenner LA. Predictive Validity of the Columbia-Suicide Severity Rating Scale among a Cohort of At-risk Veterans. Suicide Life Threat Behav. 2019 Oct;49(5):1255-1265. doi: 10.1111/sltb.12515. Epub 2018 Oct 9.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2009
• Primary Completion (Actual): November 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: April 11, 2011
• First Submitted That Met QC Criteria: April 12, 2011
• First Posted (Estimate): April 13, 2011

Study Record Updates

• Last Update Posted (Actual): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 30, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: W81XWH-09-2-0129-1