Depression, Opioid Use Disorder
Conditions
Keywords
depression, opioid use disorder, opioid agonist treatment, Ukraine
Brief 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.
Interventions
OTHERProject 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.
OTHERPayment 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
Ukrainian Institute on Public Health Policy
Yale University
Alliance for the Public's Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Cluster-randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients receiving OAT at participating sites
Exclusion criteria
* Not willing to participate * Unable to sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2) | 30 months (August 2019 - February 2022) | Site-level indicator |
| Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment | 30 months (August 2019 - February 2022) | Site-level indicator |
| Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs) | 30 months (August 2019 - February 2022) | Site-level indicator |
| Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs) | 30 months (August 2019 - February 2022) | Site-level indicator |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who continue opioid agonist treatment at the assessment time point | 3, 6, 12, 18 and 24 months after enrollment for each patient | Retention on opioid agonist treatment |
| Psychiatric Quality of Life (SF-12 mental component score) changes over time | 3, 6, 12, 18 and 24 months after enrollment for each patient | Change in the mental component score of the Short-Form Health Survey version 2 (SF-12v2) scale (0-100, higher means better health). |
Countries
Ukraine
Contacts
PRINCIPAL_INVESTIGATORSergiy Dvoryak, MD, PhD
Ukrainian Institute on Public Health Policy
Outcome results
None listed