search
Back to results

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

Primary Purpose

Depression, Opioid Use Disorder

Status
Active
Phase
Not Applicable
Locations
Ukraine
Study Type
Interventional
Intervention
Project ECHO
Payment for Performance
Sponsored by
Ukrainian Institute on Public Health Policy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring depression, opioid use disorder, opioid agonist treatment, Ukraine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All patients receiving OAT at participating sites Exclusion Criteria: Not willing to participate Unable to sign informed consent

Sites / Locations

  • Ivano-Frankivsk regional narcological dispensary
  • Kropyvnitsky regional narcological dispensary
  • Kryvyi Rig psycho-neurological dispensary
  • Kyiv city narcological clinic 'Sociotherapia'
  • Mykolaiv City Hospital #5
  • Mykolaiv regional narcological dispensary
  • Dnipropetrovsk narcological dispensary
  • Ternopil regional narcological dispensary
  • Vinnitsia regional narcological dispensary 'Sociotherapia'

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Standard of Care

SOC+ECHO

SOC+ECHO+P4P

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2)
Site-level indicator
Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment
Site-level indicator
Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs)
Site-level indicator
Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs)
Site-level indicator

Secondary Outcome Measures

Number of participants who continue opioid agonist treatment at the assessment time point
Retention on opioid agonist treatment
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).

Full Information

First Posted
April 8, 2022
Last Updated
December 1, 2022
Sponsor
Ukrainian Institute on Public Health Policy
Collaborators
Yale University, Alliance for Public Health
search

1. Study Identification

Unique Protocol Identification Number
NCT05646212
Brief Title
Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine
Acronym
MEDIUM
Official Title
Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
May 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ukrainian Institute on Public Health Policy
Collaborators
Yale University, Alliance for Public Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Opioid Use Disorder
Keywords
depression, opioid use disorder, opioid agonist treatment, Ukraine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cluster-randomized trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
Standard of care (with SSRI medications provided for free).
Arm Title
SOC+ECHO
Arm Type
Experimental
Arm Description
Standard of care (with SSRI medications provided for free), plus Project ECHO facilitation (an evidence-based tele-education intervention) for physicians
Arm Title
SOC+ECHO+P4P
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Project ECHO
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Payment for Performance
Intervention Description
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."
Primary Outcome Measure Information:
Title
Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2)
Description
Site-level indicator
Time Frame
30 months (August 2019 - February 2022)
Title
Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment
Description
Site-level indicator
Time Frame
30 months (August 2019 - February 2022)
Title
Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs)
Description
Site-level indicator
Time Frame
30 months (August 2019 - February 2022)
Title
Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs)
Description
Site-level indicator
Time Frame
30 months (August 2019 - February 2022)
Secondary Outcome Measure Information:
Title
Number of participants who continue opioid agonist treatment at the assessment time point
Description
Retention on opioid agonist treatment
Time Frame
3, 6, 12, 18 and 24 months after enrollment for each patient
Title
Psychiatric Quality of Life (SF-12 mental component score) changes over time
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients receiving OAT at participating sites Exclusion Criteria: Not willing to participate Unable to sign informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergiy Dvoryak, MD, PhD
Organizational Affiliation
Ukrainian Institute on Public Health Policy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ivano-Frankivsk regional narcological dispensary
City
Ivano-Frankivs'k
Country
Ukraine
Facility Name
Kropyvnitsky regional narcological dispensary
City
Kropyvnytskyi
Country
Ukraine
Facility Name
Kryvyi Rig psycho-neurological dispensary
City
Kryvyi Rih
Country
Ukraine
Facility Name
Kyiv city narcological clinic 'Sociotherapia'
City
Kyiv
Country
Ukraine
Facility Name
Mykolaiv City Hospital #5
City
Mykolayiv
Country
Ukraine
Facility Name
Mykolaiv regional narcological dispensary
City
Mykolayiv
Country
Ukraine
Facility Name
Dnipropetrovsk narcological dispensary
City
Pavlograd
Country
Ukraine
Facility Name
Ternopil regional narcological dispensary
City
Ternopil'
Country
Ukraine
Facility Name
Vinnitsia regional narcological dispensary 'Sociotherapia'
City
Vinnytsia
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

We'll reach out to this number within 24 hrs