Ignite Creation Date:
2024-05-06 @ 5:20 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05272176
Status:
RECRUITING
Last Update Posted:
2023-08-15
First Post:
2022-01-27
Brief Title:
Veterans Coordinated Community Care 3C Study
Sponsor:
Brown University
Organization:
Brown University
Study Overview
Official Title:
Targeted Intensive Case Management of Veterans at Risk of Suicide Post Inpatient Hospitalization
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
3C
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 N850 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None