Leveraging Regulatory Flexibility for Methadone Take-Home Dosing to Improve Retention in Treatment for Opioid Use Disorder: A Stepped-Wedge Randomized Trial to Facilitate Clinic Level Changes
NYU Langone Health
Summary
Using a stepped-wedge randomized controlled trial, the study will test whether a clinic-level multidimensional intervention conducted in 36 opioid treatment programs (OTPs) will improve clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to take- home dosing (THD) for methadone as compared to treatment as usual.
Description
Regulatory changes made during the COVID-19 public health emergency (PHE) that relaxed criteria for take- home dosing (THD) of methadone offer an opportunity to improve retention in care with a lifesaving treatment. Methadone is a highly effective medication for treating opioid use disorders (OUD) that is provided in opioid treatment programs (OTPs). Yet, longstanding regulatory restrictions limit the availability of methadone as well as create demands that heavily burden clients by requiring frequent visits to clinics. The rationale for these regulations is to safeguard against diversion and…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Clinic staff inclusion will include anyone who works at the 10 clinics that the OASAS client data system generates from the quantitative analysis in year one. In years 2-5, clinics chosen by the OASAS client data system will be placed into six cohorts. Only staff from these clinics will be eligible. * Patient inclusion will include anyone aged 18 or older who has been receiving take-home methadone for at least 30 days. Exclusion Criteria • There are no exclusion criteria related to sex/gender to increase the generalizability of the findings. The investigators will note…
Interventions
- BehavioralClinic-Level Multidimensional Intervention
The proximal goal of the intervention will be to increase OTP uptake of flexible THD. The intervention addresses facilitators and barriers to THD practices as identified by existing studies as well as those found during the first phase of the current project. The intervention will be designed to address the information gaps, training needs, and beliefs of individuals across the organizations.
Locations (4)
- University of ConnecticutStorrs, Connecticut
- University at BuffaloBuffalo, New York
- NYU Langone HealthNew York, New York
- Weill Cornell Medical CollegeNew York, New York