Clinical trial NCT01334541: A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans- Study 1
Official title: A Brief Intervention to Reduce Suicide Risk in Military Service Members and Veterans- Study 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Suicide Risk | Patient
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
name: United States Department of Defense
name: Columbia University
name: University of Pennsylvania
name: Uniformed Services University of the Health Sciences
First posted: 2011-04-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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.

Primary outcomes:
measure: Columbia Suicide-Severity Rating Scale (C-SSRS; Posner et al., 2006; Posner et al. 2008).
timeFrame: Baseline and 1, 3, and 6 month follow-up assessments
Secondary outcomes:
measure: Scale for Suicide Ideation (SSI; Beck, Kovacs, & Weissman, 1979).
timeFrame: Baseline and 1, 3, and 6 month follow-up assessments
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach VAMC
state: California
city: San Diego
country: United States
facility: San Diego VAMC
state: California
city: Denver
country: United States
facility: Denver VAMC
state: Colorado
city: Bronx
country: United States
facility: Bronx VAMC
state: New York
city: Manhattan
country: United States
facility: Manhattan VAMC
state: New York
city: Portland
country: United States
facility: Portland VAMC
state: Oregon
city: Philadelphia
country: United States
facility: Philadelphia VAMC
state: Pennsylvania
city: Milwaukee
country: United States
facility: Milwaukee VAMC
state: Wisconsin
Study officials:
affiliation: Uniformed Services University of the Health Sciences
name: Marjan Holloway, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Gregory Brown, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Denver VAMC, VISN 19 MIRECC
name: Lisa Brenner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Barbara Stanley, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Canadaigua VAMC- Center of Excellence
name: Kerry Knox, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Canandaigua VAMC- Center of Excellence
name: Glenn Currier, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.