NCT01334541

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Longer than P75 for all trials

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2011

Completed
7.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 31, 2019

Status Verified

October 1, 2018

Enrollment Period

9.2 years

First QC Date

April 11, 2011

Last Update Submit

January 30, 2019

Conditions

Suicide Risk | Patient

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Scale for Suicide Ideation (SSI; Beck, Kovacs, & Weissman, 1979).

    Baseline and 1, 3, and 6 month follow-up assessments

Study Arms (2)

SAFE VET

Behavioral: SAFE VET

E-CARE

Interventions

SAFE VETBEHAVIORAL

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

SAFE VET

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Veterans will be enrolled who:
  • have received the SAFE VET intervention in VA SAFE VET EDs or treatment-as-usual in E-CARE EDs;
  • aged 18 years or older;
  • identified as being at risk for suicide based upon presenting complaints and/or the assessment of an ED clinician;
  • able to provide 2 contacts with telephone numbers for tracking purposes; and
  • 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.

You may not qualify if:

  • Veterans will not be enrolled if they are:
  • unable to read and understand English;
  • 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
  • admitted to the VA inpatient psychiatric unit from the ED.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Long Beach VAMC

Long Beach, California, 90822, United States

Location

San Diego VAMC

San Diego, California, 92161, United States

Location

Denver VAMC

Denver, Colorado, 80220, United States

Location

Manhattan VAMC

Manhattan, New York, 10010, United States

Location

Bronx VAMC

The Bronx, New York, 10468, United States

Location

Portland VAMC

Portland, Oregon, 97239, United States

Location

Philadelphia VAMC

Philadelphia, Pennsylvania, 19104, United States

Location

Milwaukee VAMC

Milwaukee, Wisconsin, 53295, United States

Location

Related Publications (2)

  • 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.

    PMID: 33884617DERIVED

  • 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.

    PMID: 30368871DERIVED

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2011

First Posted

April 13, 2011

Study Start

September 1, 2009

Primary Completion

November 1, 2018

Study Completion

December 1, 2018

Last Updated

January 31, 2019

Record last verified: 2018-10

Locations

US(8)