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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
1,350
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.
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."
Kryvyi Rig psycho-neurological dispensary
Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine
Dnipropetrovsk narcological dispensary
Pavlohrad, Dnipropetrovsk Oblast, Ukraine
Ivano-Frankivsk regional narcological dispensary
Ivano-Frankivsk, Ivano-Frankivs'k, Ukraine
Kropyvnitsky regional narcological dispensary
Kropyvnytskyi, Kirovohrad Oblast, Ukraine
Kyiv city narcological clinic 'Sociotherapia'
Kyiv, Kyiv Oblast, Ukraine
Mykolaiv regional narcological dispensary
Mykolayiv, Mykolaiv Oblast, Ukraine
Mykolaiv City Hospital #5
Mykolayiv, Mykolayiv, Ukraine
Ternopil regional narcological dispensary
Ternopil, Ternopil Oblast, Ukraine
Vinnitsia regional narcological dispensary 'Sociotherapia'
Vinnytsia, Vinnytsia Oblast, Ukraine
Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2)
Site-level indicator
Time frame: 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
Time frame: 30 months (August 2019 - February 2022)
Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs)
Site-level indicator
Time frame: 30 months (August 2019 - February 2022)
Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs)
Site-level indicator
Time frame: 30 months (August 2019 - February 2022)
Number of participants who continue opioid agonist treatment at the assessment time point
Retention on opioid agonist treatment
Time frame: 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).
Time frame: 3, 6, 12, 18 and 24 months after enrollment for each patient
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