Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

Study Overview
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Brief Summary
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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.

Official Title
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Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

Conditions
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Depression, Opioid Use Disorder

Intervention / Treatment
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* Other: Project ECHO
* Other: Payment for Performance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients receiving OAT at participating sites Exclusion Criteria: Not willing to participate Unable to sign informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-randomized trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>Standard of care (with SSRI medications provided for free). | |
| Experimental: SOC+ECHO<br>Standard of care (with SSRI medications provided for free), plus Project ECHO facilitation (an evidence-based tele-education intervention) for physicians | Other: Project ECHO<br>* 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.<br>|
| Experimental: SOC+ECHO+P4P<br>Standard of care (with SSRI medications provided for free), plus Project ECHO facilitation (an evidence-based tele-education intervention) for physicians, plus Payment for Performance intervention | Other: Project ECHO<br>* 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.<br>Other: Payment for Performance<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs) | Site-level indicator | 30 months (August 2019 - February 2022) | 
| Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs) | Site-level indicator | 30 months (August 2019 - February 2022) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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opioid agonist treatment, Ukraine, depression, opioid use disorder