MEDIUM: Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

Sponsor

Ukrainian Institute on Public Health Policy (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05646212

Collaborator

Yale University (Other), Alliance for Public Health (Other)

1,350

Enrollment

Locations

Arms

Anticipated Duration (Months)

150

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Opioid Use Disorder	Other: Project ECHO Other: Payment for Performance	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

1350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Cluster-randomized trialCluster-randomized trial

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

Actual Study Start Date :

Jul 1, 2018

Actual Primary Completion Date :

Jan 31, 2022

Anticipated Study Completion Date :

May 31, 2023

Arms and Interventions

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."

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

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."

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All patients receiving OAT at participating sites

Exclusion Criteria:

Not willing to participate
Unable to sign informed consent

Contacts and Locations

Locations

	Site	City	Country
1	Ivano-Frankivsk regional narcological dispensary	Ivano-Frankivs'k	Ukraine
2	Kropyvnitsky regional narcological dispensary	Kropyvnytskyi	Ukraine
3	Kryvyi Rig psycho-neurological dispensary	Kryvyi Rih	Ukraine
4	Kyiv city narcological clinic 'Sociotherapia'	Kyiv	Ukraine
5	Mykolaiv City Hospital #5	Mykolayiv	Ukraine
6	Mykolaiv regional narcological dispensary	Mykolayiv	Ukraine
7	Dnipropetrovsk narcological dispensary	Pavlograd	Ukraine
8	Ternopil regional narcological dispensary	Ternopil'	Ukraine
9	Vinnitsia regional narcological dispensary 'Sociotherapia'	Vinnytsia	Ukraine