Veterans Coordinated Community Care (3C) Study

Study Overview
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Brief Summary
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Veterans Coordinated Community Care (3C) Study will recruit 850 Veterans at risk for suicide post inpatient hospitalization. Each participant will be randomly assigned to treatment as usual (TAU) or TAU plus the Coping Long Term with Active Suicide Program (CLASP), with follow-up for 6 months after discharge. Outcomes include suicide-related behaviors (including deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts) and suicidal ideation and functioning.

Detailed Description
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Suicide is a problem of great public health importance. The great majority of suicides occur among people with psychiatric disorders, and among psychiatric patients, those recently discharged from psychiatric hospitalization have highest suicide risk. Intensive post-discharge case management programs have been shown to reduce post-discharge suicides, but the rarity of these events even among recently-hospitalized patients makes it infeasible to argue for universal implementation of intensive post-discharge case management. Researchers propose to address this problem by carrying out a pragmatic trial among psychiatric inpatients in the Veterans Health Administration (VHA) healthcare system judged to be at high risk of post-discharge suicide (based on a validated prediction model). Researchers will evaluate the effects of a scalable remote post-discharge moderate intensity adjunctive intervention, the Coping Long Term with Active Suicide Program (CLASP), and carry out a heterogeneity of treatment effects (HTE) analysis to determine how these effects vary as a function of patient characteristics and features of the post-discharge treatment environment. Patients in the CLASP treatment will be asked to nominate a significant other (SO) to participate in the program with them. SO participation is optional. The aim of this research is to conduct a multi-site randomized controlled trial (N=850) of the CLASP intervention compared to treatment as usual for Veterans at risk for suicide post inpatient hospitalization. Assessments will occur at baseline and 6 months post discharge. Medical, administrative, and vital records will be obtained for each participant. The primary outcome of this study will be post-discharge suicide-related behaviors (including deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts) in the 6 months post-discharge. Researchers will also evaluate secondary outcomes involving patient suicidal ideation and functioning.

Official Title
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Targeted Intensive Case Management of Veterans at Risk of Suicide Post Inpatient Hospitalization

Conditions
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Suicide

Intervention / Treatment
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* Behavioral: Coping Long Term with Active Suicide Program (CLASP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatient Veteran at high-risk for post-discharge suicide (as flagged by the study's validated prediction model) 18 years or older Access to a telephone after discharge. Exclusion Criteria: Impaired decision-making capacity Limited or no English language proficiency Terminal illness

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coping Long Term with Active Suicide Program (CLASP)<br>The CLASP intervention is an adjunctive, telehealth-based behavioral intervention designed to reduce suicidal behavior among individuals at high risk for suicide going through periods of transition. CLASP is designed to intervene on four risk factor targets: ongoing treatment engagement, problem-solving, social and family support, and hopelessness. In addition to these general factors, the CLASP provider also has the flexibility to identify and target certain patient-specific risk factors (e.g., substance misuse) for intervention. CLASP will begin after completion of the baseline assessment, and will continue for 6 months post-discharge. CLASP will be comprised of: a) 3 initial sessions while participants are still inpatients (can occur post-discharge if needed); b) 12 brief telehealth sessions over 6-months post-discharge; c) 6 brief SO telehealth sessions. | Behavioral: Coping Long Term with Active Suicide Program (CLASP)<br>* Telehealth-based case management intervention designed to reduce suicidal behavior among individuals at high risk for suicide across the transition from inpatient hospitalization to the community.<br>|
| No Intervention: Treatment As Usual (TAU)<br>Treatment As Usual (TAU) consists of unrestricted treatment provided as part of routine care in the Veterans Health Administration (VHA) following inpatient hospitalization. Study staff will provide no additional treatment in this arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Veterans Affairs Healthcare System (VAHS) health and administrative records on suicide related behaviors | Suicide related behaviors that include deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts. | 6 months after discharge | 
| 3C Suicide Outcome Measure | Study specific aggregate measure (3C Suicide Outcome Measure) containing selected items from the Columbia-Suicide Severity Rating Scale (C-SSRS), Self-Injurious Thoughts and Behaviors Interview (SITBI), and Suicidal Behaviors Questionnaire (SBQ). | 6 months after discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Veterans Affairs Healthcare System (VAHS) health and administrative records on suicidal ideation and functioning | Suicidal ideation and functioning identified through VAHS health and administrative records | 6 months after discharge | 
| 3C Suicidal Ideation and Functioning Outcome Measure | Study specific aggregate measure (3C Suicidal Ideation and Functioning Outcome Measure) containing selected items from the Columbia-Suicide Severity Rating Scale (C-SSRS), Self-Injurious Thoughts and Behaviors Interview (SITBI), and Suicidal Behaviors Questionnaire (SBQ), P4 Screener, Suicide Attempt Beliefs Scale (SABS), Brief Reasons for Living Inventory 10-Item Version (BRFL-10), Suicide-Related Coping Scale, and Acquired Capability for Suicide Scale | 6 months after discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Veterans, Suicide Prevention, Behavioral Symptoms, Case Management