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临床试验/NCT05646212
NCT05646212已完成不适用

Integrating Treatment for Mental Disorders in Methadone Clinics in Ukraine

Ukrainian Institute on Public Health Policy15 个研究点 分布在 1 个国家目标入组 1,350 人开始时间: 2018年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,350
试验地点
15
主要终点
Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients receiving OAT at participating sites

排除标准

  • Not willing to participate
  • Unable to sign informed consent

研究组 & 干预措施

Standard of Care

No Intervention

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

SOC+ECHO+P4P

Experimental

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

干预措施: Project ECHO (Other)

SOC+ECHO+P4P

Experimental

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

干预措施: Payment for Performance (Other)

SOC+ECHO

Experimental

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

干预措施: Project ECHO (Other)

结局指标

主要结局

Proportion of patients assessed by physician using Montgomery-Asberg Depression Rating Scale (MADRS) and motivated for treatment

时间窗: 30 months (August 2019 - February 2022)

Site-level indicator

Proportion of patients screened for depression by clinical staff using Patient Health Questionnaire-2 (PHQ-2)

时间窗: 30 months (August 2019 - February 2022)

Site-level indicator

Proportion of patients retained on Selective serotonin reuptake inhibitors (SSRIs)

时间窗: 30 months (August 2019 - February 2022)

Site-level indicator

Proportion of patients initiated on Selective serotonin reuptake inhibitors (SSRIs)

时间窗: 30 months (August 2019 - February 2022)

Site-level indicator

次要结局

  • 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)
  • Psychiatric Quality of Life (SF-12 mental component score) changes over time(3, 6, 12, 18 and 24 months after enrollment for each patient)

研究者

发起方
Ukrainian Institute on Public Health Policy
申办方类型
Other
责任方
Sponsor

研究点 (15)

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