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Clinical Trials/NCT04054947
NCT04054947CompletedNot Applicable

Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios

White River Junction Veterans Affairs Medical Center2 sites in 1 country60 target enrollmentStarted: October 1, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
The Beck Scale for Suicidal Ideation (BSS)

Study Overview

Brief Summary

In the United States (U.S.), suicide is a major public health concern. U.S. Veterans who live in rural areas may be at even higher risk for suicide than their urban counterparts. Available evidence indicates that suicide risk in rural U.S. Veterans is most concentrated during high-risk care transition scenarios such as discharge from an emergency room. There is limited knowledge about effective interventions to address suicide risk. There is a critical need to develop targeted interventions that address suicide risk during high-risk care transition periods. To be effective, these interventions should address key contributors to suicide risk such as reduced engagement in treatment. This clinical trial evaluates the effect of a suicide prevention intervention to support treatment engagement during high risk transition periods such as discharge from an emergency room.

Detailed Description

In the United States (U.S.), death by suicide is a notable public health concern and a particular problem in the U.S. Veteran population. Furthermore, U.S. Veterans who live in rural areas may be at even greater risk for suicide than their urban counterparts. These risks may be concentrated during times of transition in their treatment such as after emergency room discharge. Multiple interventions have been developed to target suicide risk during periods of transition but there is limited evidence regarding their efficacy in preventing suicide. Furthermore, a key contributor to suicide risk may include limited or no engagement in care. Therefore, developing interventions to support engagement in treatment may be effective ways to help mitigate suicide risk and promote participation in care. This clinical trial studies an intervention that is designed to help support treatment engagement during periods of high risk in Veterans who live in rural areas. The trial will recruit Veterans from various treatment settings such as the emergency room, residential drug treatment programs, primary care mental health clinics, and/or inpatient psychiatric units and follow them for a period of six months. The trial evaluates not only the effect of the intervention on suicidal behavior but also measures of engagement.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Inpatient psychiatric unit:
  • Per the unit psychiatrist, hospitalization was due to concerns about acute risk for self-harm including suicidal ideation, suicide attempt, and/or admitting provider deemed the patient was at imminent risk for self-harm
  • Be a Veteran eligible to receive VA services
  • Be able to speak English
  • Inpatient medical-surgical unit:
  • Received a mental health consultation during admission on the medical-surgical unit
  • Per the consult-liaison psychiatrist, patient was recently (within past three months of hospitalization) or is currently at risk for self-harm including suicidal ideation, suicide attempt, or self-harm
  • Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English
  • Residential Rehabilitation Center (RRC) program:
  • Per the RRC treatment team, patient was recently (within past three months of hospitalization) or is currently at risk for self-harm including suicidal ideation, suicide attempt, or self-harm
  • Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English
  • Primary Mental Health Clinic (PMHC):
  • The patient was recently seen for a new evaluation in the WRJ PMHC clinic or a local integrated care clinic that are part of the White River Junction VA Medical Center Catchment Area (i.e., Burlington, Littleton, Rutland, Bennington, Brattleboro, or Keene) by either the mental health nurse practitioner, the psychologist, the psychiatry resident or a psychiatric attending
  • The patient is currently at risk for self-harm including suicidal ideation of any severity, suicide attempt, or self-harm; This could have been identified based on a formal suicide assessment scale such as the Columbia Suicide Severity Rating Scale or by clinician assessment as documented in the intake note
  • Be a Veteran eligible to receive VA services; be 18 years or older; be able to speak English

Exclusion Criteria

  • Unable to provide informed consent
  • Potentially vulnerable populations including prisoners, institutionalized patients, or involuntarily committed patients

Outcomes

Primary Outcomes

The Beck Scale for Suicidal Ideation (BSS)

Time Frame: Change from Baseline BSS at 1-, 3-, and 6-months

The BSS ranges from 0-38. While there is no established BSS cutoff score to classify suicide risk, there is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that a change of five points or more on the total BSS scores may be clinically relevant. Mean scores at baseline were calculated.

Secondary Outcomes

  • Columbia Suicide Severity Rating Scale (C-SSRS)(Number of events according to the CSSR-S at 1-, 3-, and 6-months)
  • The Beck Scale for Hopelessness (BHS)(Change from Baseline BHS at 1-, 3-, and 6-months)
  • The Partners in Health Scale (PIH) (Self Management)(Change from Baseline PIH at 1-, 3-, and 6-months)
  • Multidimensional Scale of Perceived Social Support (MSPSS)(Change from Baseline MSPSS at 1-, 3-, and 6-months)
  • Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB)(Change from Baseline INQ-15 PB at 1-, 3-, and 6-months)
  • The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB)(Baseline, 1-month, 3-month, 6-month)
  • App Engagement Scale (AES) - for Mobile Applications(Change in AES scores at 1- and 6-months)
  • Suicide-Related Coping Scale (SRCS)(Change from Baseline SRCS at 1-, 3-, and 6-months)

Investigators

Sponsor Class
Fed
Responsible Party
Principal Investigator
Principal Investigator

Brian Shiner

Staff Psychiatrist

White River Junction Veterans Affairs Medical Center

Study Sites (2)

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