Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine (MEDIUM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Depression; Opioid Use Disorder
• Intervention / Treatment: Other: Project ECHO; Other: Payment for Performance

• Study Type: Interventional
• Enrollment (Actual): 1350
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients receiving OAT at participating sites

Exclusion Criteria:

• Not willing to participate
• Unable to sign informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; Standard of care (with SSRI medications provided for free).
Experimental: SOC+ECHO; Standard of care (with SSRI medications provided for free), plus Project ECHO facilitation (an evidence-based tele-education intervention) for physicians	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.
Experimental: SOC+ECHO+P4P; 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; 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."

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ukrainian Institute on Public Health Policy
• Collaborators: Yale University; Alliance for Public Health
• Investigators: Principal Investigator: Sergiy Dvoryak, MD, PhD, Ukrainian Institute on Public Health Policy

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): January 31, 2022
• Study Completion (Anticipated): May 31, 2023

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: December 1, 2022
• First Posted (Estimate): December 12, 2022

Study Record Updates

• Last Update Posted (Estimate): December 12, 2022
• Last Update Submitted That Met QC Criteria: December 1, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: depression; opioid use disorder; opioid agonist treatment; Ukraine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Chemically-Induced Disorders; Pathologic Processes; Substance-Related Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Narcotic-Related Disorders; Depression; Disease; Psychotic Disorders; Mental Disorders; Opioid-Related Disorders
• Other Study ID Numbers: R01DA045384 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No