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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by VA Eastern Colorado Health Care System.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Columbia University
University of Pennsylvania
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01334541
First received: April 11, 2011
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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).


Condition Intervention
Suicide Risk | Patient
Behavioral: SAFE VET

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans- Study 1

Resource links provided by NLM:


Further study details as provided by VA Eastern Colorado Health Care System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Scale for Suicide Ideation (SSI; Beck, Kovacs, & Weissman, 1979). [ Time Frame: Baseline and 1, 3, and 6 month follow-up assessments ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 600
Study Start Date: September 2009
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:

  1. Risk Assessment
  2. 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.
  3. Clinical Follow-Up Protocol
E-CARE

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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334541

Contacts
Contact: Kerry Knox, Ph.D. 585-393-7690 Kerry.Knox@va.gov
Contact: Annie Nolan 585-393-7565 Annie.Nolan@va.gov

Locations
United States, California
Long Beach VAMC Recruiting
Long Beach, California, United States, 90822
San Diego VAMC Not yet recruiting
San Diego, California, United States, 92161
United States, Colorado
Denver VAMC Recruiting
Denver, Colorado, United States, 80220
United States, New York
Bronx VAMC Recruiting
Bronx, New York, United States, 10468
Manhattan VAMC Recruiting
Manhattan, New York, United States, 10010
United States, Oregon
Portland VAMC Recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Philadelphia VAMC Recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Wisconsin
Milwaukee VAMC Recruiting
Milwaukee, Wisconsin, United States, 53295
Sponsors and Collaborators
VA Eastern Colorado Health Care System
Columbia University
University of Pennsylvania
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
  More Information

No publications provided

Responsible Party: VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT01334541     History of Changes
Other Study ID Numbers: W81XWH-09-2-0129-1
Study First Received: April 11, 2011
Last Updated: July 25, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 16, 2014