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

NCT04054947 | Completed Results DMC

• 1 other identifier: 1439938
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal and Self-injurious Behavior

Keywords

Suicidal and Self-injurious Behavior

Outcome Measures

Primary Outcomes (1)

• The Beck Scale for Suicidal Ideation (BSS)

  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.

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

Secondary Outcomes (8)

• 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

• The Interpersonal Needs Questionnaire-15: Thwarted Belongingness (INQ-15 TB)

  Baseline, 1-month, 3-month, 6-month

• Interpersonal Needs Questionnaire 15: Perceived Burdensomeness (INQ-15 PB)

  Change from Baseline INQ-15 PB at 1-, 3-, and 6-months

• Columbia Suicide Severity Rating Scale (C-SSRS)

  Number of events according to the CSSR-S at 1-, 3-, and 6-months

Study Arms (2)

Suicide Prevention Program

EXPERIMENTAL

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

Behavioral: Suicide Prevention Program

Usual Care

NO INTERVENTION

Standard care that occurs as part of mental health treatment

Interventions

Suicide Prevention Program BEHAVIORAL

Structured care management to improve adherence to discharge planning.

Suicide Prevention Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• White River Junction Veterans Affairs Medical Center: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

White River Junction VA Medical Center

White River Junction, Vermont, 05009, United States

Location

Related Publications (1)

• 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.

  PMID: 35202942 DERIVED

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Brian Shiner
• Organization: White River Junction VA Medical Center

brian.shiner@va.gov

802-295-9363

Study Officials

• Brian R Shiner, MD, MPH

  White River Junction Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Psychiatrist

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: October 1, 2019
• Primary Completion: July 21, 2022
• Study Completion: July 31, 2022
• Last Updated: June 26, 2024
• Results First Posted: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)