Veterans Coordinated Community Care (3C) Study

• Sponsor: Brown University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05272176
• Collaborator: Harvard University (Other), Canandaigua VA Medical Center (U.S. Fed), West Virginia University (Other), The Warren Alpert Foundation (Other)
• Enrollment: 850
• Locations: 9
• Arms: 2
• Anticipated Duration (Months): 28.6
• Patients Per Site: 94.4
• Patients Per Site Per Month: 3.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Suicide	Behavioral: Coping Long Term with Active Suicide Program (CLASP)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 850 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Targeted Intensive Case Management of Veterans at Risk of Suicide Post Inpatient Hospitalization
• Actual Study Start Date: Jan 11, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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 (prior to discharge), 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.
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.

Outcome Measures

Primary Outcome Measures

1. Veterans Affairs Healthcare System (VAHS) health and administrative records on suicide related behaviors [6 months after discharge]

   Suicide related behaviors that include deaths due to suicide, opioid overdose, or other substance-related accidents; and nonfatal suicide attempts.

2. 3C Suicide Outcome Measure [6 months after discharge]

   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

1. Veterans Affairs Healthcare System (VAHS) health and administrative records on suicidal ideation and functioning [6 months after discharge]

   Suicidal ideation and functioning identified through VAHS health and administrative records

2. 3C Suicidal Ideation and Functioning Outcome Measure [6 months after discharge]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Arkansas Veterans Healthcare System	Little Rock	Arkansas	United States	72205
2	Greater Los Angeles Healthcare System	Los Angeles	California	United States	90073
3	Tampa VA Medical Center	Tampa	Florida	United States	33612
4	VA Boston Healthcare System	Boston	Massachusetts	United States	02301
5	Minneapolis VA Health Care System	Minneapolis	Minnesota	United States	55417
6	VA St. Louis Health Care System	Saint Louis	Missouri	United States	63125
7	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania	United States	15240
8	Ralph H. Johnson VA Health Care System	Charleston	South Carolina	United States	29401
9	VA North Texas Healthcare System	Dallas	Texas	United States	75216

Sponsors and Collaborators

• Brown University
• Harvard University
• Canandaigua VA Medical Center
• West Virginia University
• The Warren Alpert Foundation

Investigators

• Principal Investigator: Lauren Weinstock, PhD, Brown University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.

• Responsible Party: Brown University
• ClinicalTrials.gov Identifier: NCT05272176
• Other Study ID Numbers: 2109003096
• First Posted: Mar 9, 2022
• Last Update Posted: Jun 15, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Brown University: Veterans; Suicide Prevention; Behavioral Symptoms; Case Management
• Additional relevant MeSH terms: Suicide

Study Results

No Results Posted as of Jun 15, 2022