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

Ukrainian Institute on Public Health Policy

Status: Active, not recruiting

Conditions: Opioid Use Disorder; Depression

Treatments: Other: Project ECHO; Other: Payment for Performance

Study type: Interventional

Funder types: Other

Identifiers

NCT05646212

R01DA045384

Details and patient eligibility

About

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.

Enrollment: 1,350 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All patients receiving OAT at participating sites

Exclusion criteria

• Not willing to participate
• Unable to sign informed consent

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,350 participants in 3 patient groups

Standard of Care

No Intervention group

Description:

Standard of care (with SSRI medications provided for free).

SOC+ECHO

Experimental group

Description:

Standard of care (with SSRI medications provided for free), plus Project ECHO facilitation (an evidence-based tele-education intervention) for physicians

Treatment:

Other: Project ECHO

SOC+ECHO+P4P

Experimental group

Description:

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

Treatment:

Other: Payment for Performance

Other: Project ECHO