Impact of Federal and State Medications for Opioid Use Disorder (MOUD) Policy Changes During the Pandemic
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Substance Use Disorders, Alcohol Use Disorder, Opioid Use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparing Treatment Use, Retention, and Patient Outcomes Pre- and Post-implementation of Federal Policy Changes Regulating Buprenorphine and Methadone Treatment for Opioid Use Disorder
Overview
"Gold-standard" medications for opioid use disorder (MOUD) treatment combines FDA-approved medications, primarily methadone and buprenorphine, with behavioral therapies to provide "whole-patient" treatment. Prior to the pandemic, methadone and buprenorphine were subject to greater federal regulations than medications for other substance use disorders, including medication for alcohol use disorder (MAUD), which created barriers to MOUD initiation and retention. These barriers were exacerbated by physical distancing and diminished clinic capacities during the COVID-19 pandemic. To prevent healthcare disruption and expand access to MOUD treatment during the public health emergency, federal and state authorities implemented several MOUD policy changes during the pandemic to reduce barriers to MOUD initiation and retention, which subsequently became permanent. This study is an evaluation of the impacts of these policies on treatment use, retention, and patient outcomes pre- and post-MOUD policy implementation.
Detailed description
A mixed method study design will be implemented for this research study which has 3 specific aims.
Aim 1. Examine the long-term effects of MOUD policy changes on MOUD receipt, coverage, retention, and receipt of behavioral therapy, relative to commensurate measures among patients with AUD.
Aim 2. Examine the long-term effects of MOUD policy changes on outcomes for patients with OUD, including emergency department (ED) visits, inpatient hospitalization, substance use, relapse, and fatal and non-fatal overdoses, in contrast to pre-/post-period trends among our AUD comparison group.
Aim 3. Contextualize longitudinal results using qualitative methods to examine the impacts of MOUD policy changes from the perspectives of veteran patients with OUD, MOUD providers, and the Veteran's Health Administration Substance Use Disorder (VHA SUD) treatment leadership, and actors influencing the reach, effectiveness, adoption, implementation, and maintenance of MOUD policy changes.
For Aims 1 and 2, an observational cohort study will be conducted, using an interrupted time-series or difference-in-difference design to evaluate pre/post changes in treatment utilization and patient outcomes related to the nationwide MOUD policy changes introduced in 2020 expanding on access to MOUD treatment. The comparator for these analyses are patients with alcohol use disorder (AUD) for whom COVID-19 treatment disruptions applied but MOUD policies did not.
Data will be sourced from the Veteran's Health Administration Corporate Data Warehouse (CDW), including notes and Veteran's Administrations (VA) Mortality Data Repository and Community Care (CC) data. Aim 3 is a qualitative aim for which we will interview VA MOUD providers, VA substance use disorder treatment leadership, and VA patients with OUD.
Primary outcome measures
- Change in MOUD/MAUD Receipt [Time frame: 4 years pre/post policy change]
- Change in MOUD/MAUD Coverage [Time frame: 4 years pre/post policy change]
- Change in MOUD/MAUD Retention [Time frame: 4 years pre/post policy change]
- Change in Behavioral Therapy Receipt [Time frame: 4 years pre/post policy change]
- Change in Behavioral Therapy Count [Time frame: 4 years pre/post policy change]
Secondary outcome measures (9)
- Change in any emergency department visits [Time frame: 4 years pre/post policy change]
- Change in the number of emergency department visits [Time frame: 4 years pre/post policy change]
- Change in any inpatient admissions [Time frame: 4 years pre/post policy change]
- Change in the number of inpatient admissions [Time frame: 4 years pre/post policy change]
- Change in any non-fatal Overdoses [Time frame: 4 years pre/post policy change]
- Change in the count of non-fatal Overdoses [Time frame: 4 years pre/post policy change]
- Change in Fatal Overdoses [Time frame: 4 years pre/post policy change]
- Change in Substance Use [Time frame: 4 years pre/post policy change]
- Change in Substance Use Relapse [Time frame: 4 years pre/post policy change]
Eligibility criteria
Inclusion criteria
- Substance use disorder (alcohol and/or opioid) documented in the Veteran's Health Administration Corporate Data Warehouse (CDW)
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- VA Medical Center — Boston
Identifiers
NCT: NCT07232641 · H-46327 · LTF-2024C2-39670