Veterans Coordinated Community Care (3C) Study

Brown University

Status: Active, not recruiting

Conditions: Suicide

Treatments: Behavioral: Coping Long Term with Active Suicide Program (CLASP)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05272176

2109003096

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 850 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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850 participants in 2 patient groups

Coping Long Term with Active Suicide Program (CLASP)

Experimental group

Description:

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.

Treatment:

Behavioral: Coping Long Term with Active Suicide Program (CLASP)

Treatment As Usual (TAU)

No Intervention group

Description:

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.