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

• ClinicalTrials.gov Identifier: NCT04054947
• Recruitment Status: Recruiting
• First Posted: August 13, 2019
• Last Update Posted: May 21, 2020
• Sponsor: White River Junction Veterans Affairs Medical Center
• Collaborator: US Department of Veterans Affairs
• Information provided by (Responsible Party): Brian Shiner, White River Junction Veterans Affairs Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Suicidal and Self-injurious Behavior	Behavioral: Suicide Prevention Program	Not Applicable

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 and the residential drug treatment programs and follow them for a period of three months. The trial evaluates not only the effect of the intervention on suicidal behavior but also measures of engagement.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Suicide Prevention in Rural Veterans During High-risk Care Transition Scenarios
• Actual Study Start Date: October 1, 2019
• Estimated Primary Completion Date: September 2022
• Estimated Study Completion Date: September 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Suicide Prevention Program	Behavioral: Suicide Prevention Program; Structured care management to improve adherence to discharge planning.
No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures :

1. The Beck Scale for Suicidal Ideation (BSSI) [ Time Frame: Change from Baseline BSSI at 1 months ]
   The BSSI ranges from 0-38. While there is no established BSSI cutoff score to classify suicide risk, here is evidence that higher scores on the BSSI correspond to more severe suicidal ideation and that an improvement of five points or more on the total BSSI scores may be clinically relevant.
2. The Beck Scale for Suicidal Ideation (BSSI) [ Time Frame: Change from Baseline BSSI at 3 months ]
   The BSSI ranges from 0-38. While there is no established BSSI cutoff score to classify suicide risk, here is evidence that higher scores on the BSSI correspond to more severe suicidal ideation and that an improvement of five points or more on the total BSSI scores may be clinically relevant.

Secondary Outcome Measures :

1. The Beck Scale for Hopelessness (BSH) [ Time Frame: Change from Baseline BSH at 1 months ]
   The BSH ranges from 0-20 with higher scores associated with increased hopelessness.
2. The Beck Scale for Hopelessness (BSH) [ Time Frame: Change from Baseline BSH at 3 months ]
   The BSH ranges from 0-20 with higher scores associated with increased hopelessness.
3. The Partners in Health Scale (PIH) [ Time Frame: Change from Baseline PIH at 1 months ]
   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.
4. The Partners in Health Scale (PIH) [ Time Frame: Change from Baseline PIH at 3 months ]
   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.
5. Interpersonal Needs Questionnaire 15 (INQ-15) [ Time Frame: Change from Baseline INQ-15 at 1 months ]
   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.
6. Interpersonal Needs Questionnaire 15 (INQ-15) [ Time Frame: Change from Baseline INQ-15 at 3 months ]
   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.
7. Columbia Suicide Severity Rating Scale (CSSR-S) [ Time Frame: Number of events according to the CSSR-S at 1 months ]
   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.
8. Columbia Suicide Severity Rating Scale (CSSR-S) [ Time Frame: Number of events according to the CSSR-S at 3 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Sarah L Cornelius, BS; 802-295-9363 ext 5323; sarah.cornelius@va.gov

Contact: Jenna Forehand, MPH; 802-295-9363 ext 6946; jenna.forehand@va.gov

Locations

United States, Vermont

White River Junction VA Medical Center; Recruiting

White River Junction, Vermont, United States, 05009

Contact: Sarah Cornelius, BS 802-295-9363 ext 5323 sarah.cornelius@va.gov

Sponsors and Collaborators

White River Junction Veterans Affairs Medical Center

US Department of Veterans Affairs

Investigators

• Principal Investigator: Brian R Shiner, MD, MPH; White River Junction Veterans Affairs Medical Center

More Information

• Responsible Party: Brian Shiner, Staff Psychiatrist, White River Junction Veterans Affairs Medical Center
• ClinicalTrials.gov Identifier: NCT04054947
• Other Study ID Numbers: 1439938
• First Posted: August 13, 2019
• Last Update Posted: May 21, 2020
• Last Verified: May 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian Shiner, White River Junction Veterans Affairs Medical Center:

Suicidal and Self-injurious Behavior

Additional relevant MeSH terms:

Suicide; Self-Injurious Behavior; Behavioral Symptoms