Veterans Coordinated Community Care (3C) Study

NCT ID: NCT05272176

Last Updated: 2026-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

850 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-11

Study Completion Date

2026-06-30

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.

Conditions

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Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Coping Long Term with Active Suicide Program (CLASP)

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.

Group Type EXPERIMENTAL

Coping Long Term with Active Suicide Program (CLASP)

Intervention Type BEHAVIORAL

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.

Treatment As Usual (TAU)

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Coping Long Term with Active Suicide Program (CLASP)

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.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Harvard University

OTHER

Sponsor Role collaborator

Canandaigua VA Medical Center

FED

Sponsor Role collaborator

West Virginia University

OTHER

Sponsor Role collaborator

The Warren Alpert Foundation

UNKNOWN

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lauren Weinstock, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States

Site Status

VA Boston Healthcare System

Boston, Massachusetts, United States

Site Status

Minneapolis VA Health Care System

Minneapolis, Minnesota, United States

Site Status

VA St. Louis Health Care System

St Louis, Missouri, United States

Site Status

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States

Site Status

VA Tennessee Valley Health Care System

Murfreesboro, Tennessee, United States

Site Status

VA North Texas Healthcare System

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Miller IW, Gaudiano BA, Weinstock LM. The Coping Long Term with Active Suicide Program: Description and Pilot Data. Suicide Life Threat Behav. 2016 Dec;46(6):752-761. doi: 10.1111/sltb.12247. Epub 2016 Apr 2.

Reference Type BACKGROUND
PMID: 27038050 (View on PubMed)

Kessler RC, Bauer MS, Bishop TM, Demler OV, Dobscha SK, Gildea SM, Goulet JL, Karras E, Kreyenbuhl J, Landes SJ, Liu H, Luedtke AR, Mair P, McAuliffe WHB, Nock M, Petukhova M, Pigeon WR, Sampson NA, Smoller JW, Weinstock LM, Bossarte RM. Using Administrative Data to Predict Suicide After Psychiatric Hospitalization in the Veterans Health Administration System. Front Psychiatry. 2020 May 6;11:390. doi: 10.3389/fpsyt.2020.00390. eCollection 2020.

Reference Type BACKGROUND
PMID: 32435212 (View on PubMed)

Miller IW, Camargo CA Jr, Arias SA, Sullivan AF, Allen MH, Goldstein AB, Manton AP, Espinola JA, Jones R, Hasegawa K, Boudreaux ED; ED-SAFE Investigators. Suicide Prevention in an Emergency Department Population: The ED-SAFE Study. JAMA Psychiatry. 2017 Jun 1;74(6):563-570. doi: 10.1001/jamapsychiatry.2017.0678.

Reference Type BACKGROUND
PMID: 28456130 (View on PubMed)

Weinstock LM, Bishop TM, Bauer MS, Benware J, Bossarte RM, Bradley J, Dobscha SK, Gibbs J, Gildea SM, Graves H, Haas G, House S, Kennedy CJ, Landes SJ, Liu H, Luedtke A, Marx BP, Miller A, Nock MK, Owen RR, Pigeon WR, Sampson NA, Santiago-Colon A, Shivakumar G, Urosevic S, Kessler RC. Design of a multicenter randomized controlled trial of a post-discharge suicide prevention intervention for high-risk psychiatric inpatients: The Veterans Coordinated Community Care Study. Int J Methods Psychiatr Res. 2024 Dec;33(4):e70003. doi: 10.1002/mpr.70003.

Reference Type DERIVED
PMID: 39352173 (View on PubMed)

Other Identifiers

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2109003096

Identifier Type: -

Identifier Source: org_study_id

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