Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

Depression Clinical Trial

— MEDIUM  

Official title:

Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05646212
• Other study ID #: R01DA045384
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Ukrainian Institute on Public Health Policy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 1:1:1 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 (N~2000 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 (N=1,350) 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1350
• Est. completion date: May 31, 2025
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients receiving OAT at participating sites

Exclusion Criteria:

• Not willing to participate

• Unable to sign informed consent

Related Conditions & MeSH terms

• Depression
• Mental Disorders
• Opioid Use Disorder
• Opioid-Related Disorders
• Psychotic Disorders

Intervention

Other:
• Project ECHO
Project Extension for Community Healthcare Outcomes® (ECHO): This EBP, tested originally to facilitate HCV care into non-specialty settings, is based on established educational theories of social learning & behavior change in where non-specialists collaborate with specialists, resulting in an innovative healthcare delivery model that results in equivalent quality care for patients in non-specialty settings.
• Payment for Performance
P4P in healthcare, endorsed by 3 IOM reports, gives financial incentives to clinicians for adhering to clinical guidelines and achieving better health outcomes. One 2007 IOM report recommended "physician incentives so that profitability and improved healthcare delivery is aligned with patient safety goals and strengthen the business case for healthcare quality and safety."

Locations

Country	Name	City	State
Ukraine	Ivano-Frankivsk regional narcological dispensary	Ivano-Frankivs'k
Ukraine	Kropyvnitsky regional narcological dispensary	Kropyvnytskyi	Kirovohrad
Ukraine	Kryvyi Rig psycho-neurological dispensary	Kryvyi Rih	Dnipropetrovsk
Ukraine	Kyiv city narcological clinic 'Sociotherapia'	Kyiv
Ukraine	Mykolaiv City Hospital #5	Mykolayiv
Ukraine	Mykolaiv regional narcological dispensary	Mykolayiv	Mykolaiv
Ukraine	Dnipropetrovsk narcological dispensary	Pavlograd	Dnipropetrovsk
Ukraine	Ternopil regional narcological dispensary	Ternopil'	Ternopil
Ukraine	Vinnitsia regional narcological dispensary 'Sociotherapia'	Vinnytsia

Sponsors (3)

Lead Sponsor	Collaborator
Ukrainian Institute on Public Health Policy	Alliance for Public Health, Yale University

Country where clinical trial is conducted

Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2)	Site-level indicator	30 months (August 2019 - February 2022)
Primary	Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment	Site-level indicator	30 months (August 2019 - February 2022)
Primary	Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs)	Site-level indicator	30 months (August 2019 - February 2022)
Primary	Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs)	Site-level indicator	30 months (August 2019 - February 2022)
Secondary	Number of participants who continue opioid agonist treatment at the assessment time point	Retention on opioid agonist treatment	3, 6, 12, 18 and 24 months after enrollment for each patient
Secondary	Psychiatric Quality of Life (SF-12 mental component score) changes over time	Change in the mental component score of the Short-Form Health Survey version 2 (SF-12v2) scale (0-100, higher means better health).	3, 6, 12, 18 and 24 months after enrollment for each patient