Veterans Coordinated Community Care (3C) Study

Suicide Clinical Trial

— 3C  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05272176
• Other study ID #: 2109003096
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2022
• Est. completion date: June 2024

Study information

• Verified date: August 2023
• Source: Brown University
• Contact: Lauren Weinstock, PhD
• Phone: 401-455-6304
• Email: lauren_weinstock[@]brown.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 850
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide

Intervention

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.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System	Boston	Massachusetts
United States	VA North Texas Healthcare System	Dallas	Texas
United States	Central Arkansas Veterans Healthcare System	Little Rock	Arkansas
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota
United States	VA Tennessee Valley Health Care System	Murfreesboro	Tennessee
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	VA St. Louis Health Care System	Saint Louis	Missouri

Sponsors (5)

Lead Sponsor	Collaborator
Brown University	Canandaigua VA Medical Center, Harvard University, The Warren Alpert Foundation, West Virginia University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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