Clinical trial NCT05272176: Veterans Coordinated Community Care (3C) Study
Official title: Targeted Intensive Case Management of Veterans at Risk of Suicide Post Inpatient Hospitalization
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicide
Keywords: Veterans
Suicide Prevention
Behavioral Symptoms
Case Management
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: Harvard University
name: Canandaigua VA Medical Center
name: West Virginia University
name: The Warren Alpert Foundation
First posted: 2022-03-09
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Veterans Affairs Healthcare System (VAHS) health and administrative records on suicide related behaviors
timeFrame: 6 months after discharge
measure: 3C Suicide Outcome Measure
timeFrame: 6 months after discharge
Secondary outcomes:
measure: Veterans Affairs Healthcare System (VAHS) health and administrative records on suicidal ideation and functioning
timeFrame: 6 months after discharge
measure: 3C Suicidal Ideation and Functioning Outcome Measure
timeFrame: 6 months after discharge
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System
state: Arkansas
city: Boston
country: United States
facility: VA Boston Healthcare System
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
city: Saint Louis
country: United States
facility: VA St. Louis Health Care System
state: Missouri
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System
state: Pennsylvania
city: Murfreesboro
country: United States
facility: VA Tennessee Valley Health Care System
state: Tennessee
city: Dallas
country: United States
facility: VA North Texas Healthcare System
state: Texas
Study officials:
affiliation: Brown University
name: Lauren Weinstock, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.