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Veterans Coordinated Community Care (3C) Study (3C)

Primary Purpose

Suicide

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coping Long Term with Active Suicide Program (CLASP)
Sponsored by
Brown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide focused on measuring Veterans, Suicide Prevention, Behavioral Symptoms, Case Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Central Arkansas Veterans Healthcare SystemRecruiting
  • VA Boston Healthcare SystemRecruiting
  • Minneapolis VA Health Care SystemRecruiting
  • VA St. Louis Health Care SystemRecruiting
  • VA Pittsburgh Healthcare SystemRecruiting
  • VA Tennessee Valley Health Care SystemRecruiting
  • VA North Texas Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Coping Long Term with Active Suicide Program (CLASP)

Treatment As Usual (TAU)

Arm 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 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.

Outcomes

Primary Outcome Measures

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.
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).

Secondary Outcome Measures

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
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

Full Information

First Posted
January 27, 2022
Last Updated
August 14, 2023
Sponsor
Brown University
Collaborators
Harvard University, Canandaigua VA Medical Center, West Virginia University, The Warren Alpert Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05272176
Brief Title
Veterans Coordinated Community Care (3C) Study
Acronym
3C
Official Title
Targeted Intensive Case Management of Veterans at Risk of Suicide Post Inpatient Hospitalization
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 11, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brown University
Collaborators
Harvard University, Canandaigua VA Medical Center, West Virginia University, The Warren Alpert Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Veterans, Suicide Prevention, Behavioral Symptoms, Case Management

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
850 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coping Long Term with Active Suicide Program (CLASP)
Arm Type
Experimental
Arm 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.
Arm Title
Treatment As Usual (TAU)
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Coping Long Term with Active Suicide Program (CLASP)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Veterans Affairs Healthcare System (VAHS) health and administrative records on suicide related behaviors
Description
Suicide related behaviors that include deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts.
Time Frame
6 months after discharge
Title
3C Suicide Outcome Measure
Description
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).
Time Frame
6 months after discharge
Secondary Outcome Measure Information:
Title
Veterans Affairs Healthcare System (VAHS) health and administrative records on suicidal ideation and functioning
Description
Suicidal ideation and functioning identified through VAHS health and administrative records
Time Frame
6 months after discharge
Title
3C Suicidal Ideation and Functioning Outcome Measure
Description
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
Time Frame
6 months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Weinstock, PhD
Phone
401-455-6304
Email
lauren_weinstock@brown.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Bishop, PhD
Phone
585-504-9787
Email
todd.bishop@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Weinstock, PhD
Organizational Affiliation
Brown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samuel House, PhD
Phone
501-257-3131
Email
Samuel.house@va.gov
First Name & Middle Initial & Last Name & Degree
Richard Owen, PhD
Phone
501 257-1710
Email
Richard.owen2@va.gov
Facility Name
VA Boston Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Bradley, MD
Phone
774-826-2473
Email
John.Bradley7@va.gov
Facility Name
Minneapolis VA Health Care System
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Snezana Urosevic, PhD
Phone
612-467-3897
Ext
313897
Email
Snezana.Urosevic@va.gov
Facility Name
VA St. Louis Health Care System
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Benware, PhD
Phone
314-652-4100
Ext
63227
Email
Jeffrey.Benware@va.gov
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gretchen Haas, PhD
Phone
412-513-6254
Email
Gretchen.hass@va.gov
Facility Name
VA Tennessee Valley Health Care System
City
Murfreesboro
State/Province
Tennessee
ZIP/Postal Code
37129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Gibbs, MD
Phone
615-873-6822
Email
jessica.gibbs2@va.gov
Facility Name
VA North Texas Healthcare System
City
Dallas
State/Province
Texas
ZIP/Postal Code
75216
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aletha Miller, PhD
Phone
214-857-0534
Email
Aletha.miller@va.gov

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified study data will be made available through the Inter-university Consortium for Political and Social Research (ICPSR) after the study has ended.
IPD Sharing Time Frame
De-identified data will become available after the study has ended.
IPD Sharing Access Criteria
De-identified data are made available to users at ICPSR member institutions.
Citations:
PubMed Identifier
27038050
Citation
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.
Results Reference
background
PubMed Identifier
32435212
Citation
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.
Results Reference
background
PubMed Identifier
28456130
Citation
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.
Results Reference
background

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Veterans Coordinated Community Care (3C) Study

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