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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Suicide
• Intervention / Treatment: Behavioral: Coping Long Term with Active Suicide Program (CLASP)

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.

• Study Type: Interventional
• Enrollment (Estimated): 850
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lauren Weinstock, PhD; Phone Number: 401-455-6304; Email: lauren_weinstock@brown.edu
• Study Contact Backup: Name: Todd Bishop, PhD; Phone Number: 585-504-9787; Email: todd.bishop@va.gov

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Recruiting
      • Central Arkansas Veterans Healthcare System
      • Contact: Samuel House, PhD; Phone Number: 501-257-3131; Email: Samuel.house@va.gov
      • Contact: Richard Owen, PhD; Phone Number: 501 257-1710; Email: Richard.owen2@va.gov
  • Massachusetts
    • Boston, Massachusetts, United States, 02301
      • Recruiting
      • VA Boston Healthcare System
      • Contact: John Bradley, MD; Phone Number: 774-826-2473; Email: John.Bradley7@va.gov
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Recruiting
      • Minneapolis VA Health Care System
      • Contact: Snezana Urosevic, PhD; Phone Number: 313897 612-467-3897; Email: Snezana.Urosevic@va.gov
  • Missouri
    • Saint Louis, Missouri, United States, 63125
      • Recruiting
      • VA St. Louis Health Care System
      • Contact: Jeffrey Benware, PhD; Phone Number: 63227 314-652-4100; Email: Jeffrey.Benware@va.gov
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15240
      • Recruiting
      • VA Pittsburgh Healthcare System
      • Contact: Gretchen Haas, PhD; Phone Number: 412-513-6254; Email: Gretchen.hass@va.gov
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37129
      • Recruiting
      • VA Tennessee Valley Health Care System
      • Contact: Jessica Gibbs, MD; Phone Number: 615-873-6822; Email: jessica.gibbs2@va.gov
  • Texas
    • Dallas, Texas, United States, 75216
      • Recruiting
      • VA North Texas Healthcare System
      • Contact: Aletha Miller, PhD; Phone Number: 214-857-0534; Email: Aletha.miller@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.	Behavioral: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: Harvard University; West Virginia University; Canandaigua VA Medical Center; The Warren Alpert Foundation
• Investigators: Principal Investigator: Lauren Weinstock, PhD, Brown University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2022
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): August 15, 2023
• Last Update Submitted That Met QC Criteria: August 14, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Veterans; Case Management; Suicide Prevention; Behavioral Symptoms
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: 2109003096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No