Back to resultsSuicide Prevention in Rural Veterans During High-risk Care Transition Scenarios
Primary Purpose
Suicidal and Self-injurious Behavior
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Suicide Prevention Program
Sponsored by
About this trial
This is an interventional treatment trial for Suicidal and Self-injurious Behavior focused on measuring Suicidal and Self-injurious Behavior
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
Sites / Locations
- White River Junction VA Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Suicide Prevention Program
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
The Beck Scale for Suicidal Ideation (BSS)
The BSSI ranges from 0-38. While there is no established BSS cutoff score to classify suicide risk, here is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that an improvement of five points or more on the total BSS scores may be clinically relevant.
Secondary Outcome Measures
The Beck Scale for Hopelessness (BHS)
The BHS ranges from 0-20 with higher scores associated with increased hopelessness.
The Partners in Health Scale (PIH)
The PIH is used to measure patient self-management of chronic conditions. It is a 12-item instrument, each question measured on a Likert scale of 0-8. Higher scores indicate better self-management.
Interpersonal Needs Questionnaire 15 (INQ-15)
The INQ-15 is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness.
Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a valid and reliable scale that includes a seven-item subscale that asks patients to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors.
Multidimensional Scale of Perceived Social Support (MSPSS)
The MSPSS is a 12-item self-reported scale that is designed to ask about support from several sources including friends, family and significant other. The scale has been shown to have good internal and test-retest reliability as well as good validity.
Suicide-Related Coping Scale (SRCS)
This scale includes 17 questions related to a patient's perception of their ability to cope with suicidal thoughts. Each item is assessed using a 5-point Likert scale and the measure has been developed based on two studies of suicide prevention strategies conducted within Veteran populations. The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale. Both subscales have shown good acceptable internal consistency.
App Engagement Scale (AES)
The AES is adapted from the end-user version of the Mobile Application Rating Scale (uMARS). The AES has been studied in patients with mental health conditions, has been shown to have good internal reliability, and is strongly related to app engagement.
Full Information
NCT ID
NCT04054947
First Posted
August 9, 2019
Last Updated
February 21, 2023
Sponsor
White River Junction Veterans Affairs Medical Center
Collaborators
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT04054947
Brief Title
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
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
White River Junction Veterans Affairs Medical Center
Collaborators
US Department of Veterans Affairs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicidal and Self-injurious Behavior
Keywords
Suicidal and Self-injurious Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Suicide Prevention Program
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Suicide Prevention Program
Intervention Description
Structured care management to improve adherence to discharge planning.
Primary Outcome Measure Information:
Title
The Beck Scale for Suicidal Ideation (BSS)
Description
The BSSI ranges from 0-38. While there is no established BSS cutoff score to classify suicide risk, here is evidence that higher scores on the BSS correspond to more severe suicidal ideation and that an improvement of five points or more on the total BSS scores may be clinically relevant.
Time Frame
Change from Baseline BSS at 1-, 3-, and 6-months
Secondary Outcome Measure Information:
Title
The Beck Scale for Hopelessness (BHS)
Description
The BHS ranges from 0-20 with higher scores associated with increased hopelessness.
Time Frame
Change from Baseline BHS at 1-, 3-, and 6-months
Title
The Partners in Health Scale (PIH)
Description
The PIH is used to measure patient self-management of chronic conditions. It is a 12-item instrument, each question measured on a Likert scale of 0-8. Higher scores indicate better self-management.
Time Frame
Change from Baseline PIH at 1-, 3-, and 6-months
Title
Interpersonal Needs Questionnaire 15 (INQ-15)
Description
The INQ-15 is a 15-item self-report scale that measures thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is measured on a 7-point Likert scale, with higher scores suggesting lower perceived connectedness.
Time Frame
Change from Baseline INQ-15 at 1-, 3-, and 6-months
Title
Columbia Suicide Severity Rating Scale (C-SSRS)
Description
The C-SSRS is a valid and reliable scale that includes a seven-item subscale that asks patients to self-report on actual attempts, interrupted attempts, aborted attempts, and preparatory acts or behaviors.
Time Frame
Number of events according to the CSSR-S at 1-, 3-, and 6-months
Title
Multidimensional Scale of Perceived Social Support (MSPSS)
Description
The MSPSS is a 12-item self-reported scale that is designed to ask about support from several sources including friends, family and significant other. The scale has been shown to have good internal and test-retest reliability as well as good validity.
Time Frame
Change from Baseline MSPSS at 1-, 3-, and 6-months
Title
Suicide-Related Coping Scale (SRCS)
Description
This scale includes 17 questions related to a patient's perception of their ability to cope with suicidal thoughts. Each item is assessed using a 5-point Likert scale and the measure has been developed based on two studies of suicide prevention strategies conducted within Veteran populations. The scale includes two subscales including an External Coping subscale and an Internal Coping Subscale. Both subscales have shown good acceptable internal consistency.
Time Frame
Change from Baseline SRCS at 1-, 3-, and 6-months
Title
App Engagement Scale (AES)
Description
The AES is adapted from the end-user version of the Mobile Application Rating Scale (uMARS). The AES has been studied in patients with mental health conditions, has been shown to have good internal reliability, and is strongly related to app engagement.
Time Frame
Change from Baseline AES at 1- and 6-months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian R Shiner, MD, MPH
Organizational Affiliation
White River Junction Veterans Affairs Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
White River Junction VA Medical Center
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35202942
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.
Results Reference
derived
Learn more about this trial
Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios
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