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

Suicidal and Self-injurious Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04054947
• Other study ID #: 1439938
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2023
• Source: White River Junction Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Self-Injurious Behavior
• Suicidal and Self-injurious Behavior
• Suicide

Intervention

Behavioral:
• Suicide Prevention Program
Structured care management to improve adherence to discharge planning.

Locations

Country	Name	City	State
United States	White River Junction VA Medical Center	White River Junction	Vermont

Sponsors (2)

Lead Sponsor	Collaborator
White River Junction Veterans Affairs Medical Center	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from Baseline BSS at 1-, 3-, and 6-months
Secondary	The Beck Scale for Hopelessness (BHS)	The BHS ranges from 0-20 with higher scores associated with increased hopelessness.	Change from Baseline BHS at 1-, 3-, and 6-months
Secondary	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.	Change from Baseline PIH at 1-, 3-, and 6-months
Secondary	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.	Change from Baseline INQ-15 at 1-, 3-, and 6-months
Secondary	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.	Number of events according to the CSSR-S at 1-, 3-, and 6-months
Secondary	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.	Change from Baseline MSPSS at 1-, 3-, and 6-months
Secondary	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.	Change from Baseline SRCS at 1-, 3-, and 6-months
Secondary	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.	Change from Baseline AES at 1- and 6-months