Clinical trial NCT06596044: Suicide Prevention After Community Care Discharge
Official title: Suicide Prevention In Department of Veterans Affairs Community Care Network Mental Health Settings
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Suicide Prevention
Keywords: Mental health education
Clinical trial
Suicidal ideation
Suicide, attempted
Self-injurious Behavior
Suicide
Suicide Prevention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: White River Junction Veterans Affairs Medical Center
First posted: 2024-09-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to one of two groups in parallel: VA BIC plus standard care vs. standard care alone
Primary purpose: PREVENTION

Brief summary: The study is of high importance to Veterans' health because it will study a suicide prevention intervention in a Veteran population that is at high risk of suicide but has not been a specific focus of the Veteran Affairs' (VA's) suicide prevention efforts. Specifically, a growing number of Veterans are now receiving acute mental health treatment in VA-purchased settings (commonly referred to as Community Care). While these Veterans are at high risk of suicide after discharge, very little is known about how to prevent suicide in these Veterans. This study will directly address this problem by looking at whether a promising suicide prevention strategy called the VA Brief Intervention and Contact Program (VA BIC) can decrease the risk of suicide in Veterans after they are discharged from a non-VA mental health treatment setting. The proposed research is highly pertinent to the VA's top clinical priority-to prevent suicide in Veterans.

Detailed description: Background: Suicide is a chief concern in Veterans. An increasing number of Veterans are accessing acute psychiatric treatment in non-VA settings. There is little knowledge about effective strategies to mitigate suicide risk in this population. A promising suicide prevention strategy, called the VA Brief Intervention and Contact Program (BIC), has been developed. VA BIC is designed to meet the unique needs of Veterans. Pilot studies of VA BIC in VA settings have suggested that VA BIC may address key factors related to suicide risk during care transitions including social connectedness and treatment engagement. Based on these promising results and given the critical gaps in suicide prevention care in Veterans who receive acute psychiatric treatment in non-VA settings, it is essential to determine whether VA BIC can reduce suicide risk in this high-risk population.

Objectives: This project aims to 1) Identify the effect of VA BIC on suicidal ideation after a non-VA mental health discharge, compared to standard care alone; 2) Identify the effect of VA BIC on engagement in mental health care after a non-VA mental health discharge, compared to standard care alone; 3) Identify the effect of VA BIC on social connectedness after a non-VA mental health discharge, compared to standard care alone; and 4) Compare the effect of VA BIC on suicidal behavior after a non-VA mental health discharge, compared to standard care alone.

Methods: This is an assessor-blinded, randomized control trial of VA BIC plus standard care compared to standard care alone. The trial will enroll up to 120 participants aged 18 years and older who are Veterans eligible to receive VA services and have received acute psychiatric treatment in non-VA settings affiliated with VA in Northern New England. Participants will be randomized to either the VA BIC intervention plus standard care or standard care alone. Suicidal ideation, engagement in mental health care, social connectedness and suicidal behavior will be measured at baseline and three, six , and nine months follow-up.

Hypothesis: Veterans receiving the VA BIC intervention plus standard care will report reductions in suicidal thoughts at follow-up assessments compared to Veterans receiving standard care alone. Veterans receiving the VA BIC intervention plus standard care will experience an increase in engagement in mental health care and social connectedness at follow-up assessments compared to Veterans receiving standard care alone

Eligibility criteria: Inclusion Criteria:

* Veteran who is eligible to receive VA services;
* 18 years or older;
* able to speak English;
* received acute psychiatric treatment in a non-VA setting affiliated with VA in Northern New England;
* endorse recent suicidal ideation (score 2+ on Beck Scale for Suicidal Ideation).

Exclusion Criteria:

* Unable to provide informed consent;
* Currently receiving assertive community treatment;
* Potentially vulnerable populations including prisoners, institutionalized patients, or patients currently admitted on involuntary commitment status;
* Study physician deems the patient is not clinically appropriate because of clinical status such as presence of active psychosis or dementia.

Primary outcomes:
measure: Suicidal Ideation: The Beck Scale for Suicidal Ideation (BSS)
timeFrame: Baseline to 9 months post-baseline
Secondary outcomes:
measure: Mental Healthcare Utilization: The number of mental health visits attended
timeFrame: Baseline to 3 months post-baseline
measure: Patient perception of ability to cope with suicidal behavior: The Suicide-Related Coping Scale (SRCS)
timeFrame: Baseline to 9 months post-baseline
measure: Social Connectedness: Interpersonal Needs Questionnaire-15 (INQ-15)
timeFrame: Baseline to 9 months post-baseline
measure: Suicide Attempt Events: Fatal and non-Fatal Suicide Attempts
timeFrame: Baseline to 9 months post-baseline
Other outcomes:
Locations:
city: White River Junction
country: United States
facility: White River Junction VA Medical Center, White River Junction, VT
state: Vermont
Study officials:
affiliation: White River Junction VA Medical Center, White River Junction, VT
name: Natalie Riblet, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: