Ignite Creation Date:
2024-05-06 @ 6:24 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05646212
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2022-04-08
Brief Title:
Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine
Sponsor:
Ukrainian Institute on Public Health Policy
Organization:
Ukrainian Institute on Public Health Policy
Study Overview
Official Title:
Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
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:
MEDIUM
Brief Summary:
The MEDIUM study U01DA045384 is a cluster-randomized trial based in Ukraine The main goal of the study is to test the implementation strategies for mental health treatment services in OAT clinics
The study enrolled 12 OAT clinics from 12 geographically and epidemiologically diverse regions and randomized them 111 to three implementation arms standard of care SoC ECHO facilitation and ECHO plus pay-for-performance P4P incentives Project ECHO is an evidence-based telehealth intervention connecting clinicians with national experts for short thematic didactic sessions and case discussions All sites are provided with a modified Screening Brief Intervention and Referral to Treatment mSBIRT intervention manual for mental disorders and regular supply of two selective serotonin reuptake inhibitors SSRI medications All current and new patients at participating sites N2000 at study start are automatically eligible for SSRI prescription The main outcomes of the study are the elements of mental health continuum of care screening diagnosis treatment and retention These outcomes are assessed in the entire patient population using de-personalized data extracted from the electronic medical record system A sub-sample of patients N1350 was recruited into a cohort and consented to assess prevalence and severity of mental disorders various factors related to the uptake of and retention in mental health treatment addiction severity other substance use co-morbidities as well as other important covariates These assessments are done at baseline 6 12 18 and 24 months after enrollment
The study enrolled 12 OAT clinics from 12 geographically and epidemiologically diverse regions and randomized them 111 to three implementation arms standard of care SoC ECHO facilitation and ECHO plus pay-for-performance P4P incentives Project ECHO is an evidence-based telehealth intervention connecting clinicians with national experts for short thematic didactic sessions and case discussions All sites are provided with a modified Screening Brief Intervention and Referral to Treatment mSBIRT intervention manual for mental disorders and regular supply of two selective serotonin reuptake inhibitors SSRI medications All current and new patients at participating sites N2000 at study start are automatically eligible for SSRI prescription The main outcomes of the study are the elements of mental health continuum of care screening diagnosis treatment and retention These outcomes are assessed in the entire patient population using de-personalized data extracted from the electronic medical record system A sub-sample of patients N1350 was recruited into a cohort and consented to assess prevalence and severity of mental disorders various factors related to the uptake of and retention in mental health treatment addiction severity other substance use co-morbidities as well as other important covariates These assessments are done at baseline 6 12 18 and 24 months after enrollment
Detailed Description:
None
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