Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

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.

Conditions

• Depression
• Opioid Use Disorder

Interventions

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.

OTHER

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."

Sponsors & Collaborators

• Yale University

  collaborator OTHER

• Alliance for the Public's Health

  collaborator OTHER

• Ukrainian Institute on Public Health Policy

  lead OTHER

Principal Investigators

• Sergiy Dvoryak, MD, PhD · Ukrainian Institute on Public Health Policy

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-07-01

Primary Completion

2022-01-31

Completion

2026-05-31

Countries

• Ukraine

Study Locations