Clinical trial NCT04054947: Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios
Official title: Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicidal and Self-injurious Behavior
Keywords: Suicidal and Self-injurious Behavior
Lead sponsor: White River Junction Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: US Department of Veterans Affairs
First posted: 2019-08-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Beck Scale for Suicidal Ideation (BSS)
timeFrame: Change from Baseline BSS at 1-, 3-, and 6-months
Secondary outcomes:
measure: The Beck Scale for Hopelessness (BHS)
timeFrame: Change from Baseline BHS at 1-, 3-, and 6-months
measure: The Partners in Health Scale (PIH) (Self Management)
timeFrame: Change from Baseline PIH at 1-, 3-, and 6-months
measure: The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB)
timeFrame: Baseline, 1-month, 3-month, 6-month
measure: Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB)
timeFrame: Change from Baseline INQ-15 PB at 1-, 3-, and 6-months
measure: Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Number of events according to the CSSR-S at 1-, 3-, and 6-months
measure: Multidimensional Scale of Perceived Social Support (MSPSS)
timeFrame: Change from Baseline MSPSS at 1-, 3-, and 6-months
measure: Suicide-Related Coping Scale (SRCS)
timeFrame: Change from Baseline SRCS at 1-, 3-, and 6-months
measure: App Engagement Scale (AES) - for Mobile Applications
timeFrame: Change in AES scores at 1- and 6-months
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: White River Junction VA Medical Center
state: Vermont
Study officials:
affiliation: White River Junction Veterans Affairs Medical Center
name: Brian R Shiner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riblet NB, Kenneally L, Stevens S, Watts BV, Gui J, Forehand J, Cornelius S, Rousseau GS, Schwartz JC, Shiner B. A virtual, pilot randomized trial of a brief intervention to prevent suicide in an integrated healthcare setting. Gen Hosp Psychiatry. 2022 Mar-Apr;75:68-74. doi: 10.1016/j.genhosppsych.2022.02.002. Epub 2022 Feb 18.