Comparing Treatment Use, Retention, and Patient Outcomes Pre- and Post-implementation of Federal Policy Changes Regulating Buprenorphine and Methadone Treatment for Opioid Use Disorder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 185,810
- 试验地点
- 1
- 主要终点
- Change in MOUD/MAUD Receipt
研究概览
简要总结
"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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Substance use disorder (alcohol and/or opioid) documented in the Veteran's Health Administration Corporate Data Warehouse (CDW)
排除标准
- 未提供
研究组 & 干预措施
VA Patients with substance use disorder
Mutually exclusive groups of patients with OUD and AUD (and no co-occurring OUD), who will be matched 1:1 on age, gender, race, rural/urban residence, and state for the the pre (03/2016-02/2020) and post periods (03/2020-02/2024).
结局指标
主要结局
Change in MOUD/MAUD Receipt
时间窗: 4 years pre/post policy change
Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in MOUD/MAUD Coverage
时间窗: 4 years pre/post policy change
Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in MOUD/MAUD Retention
时间窗: 4 years pre/post policy change
Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in Behavioral Therapy Count
时间窗: 4 years pre/post policy change
Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
Change in Behavioral Therapy Receipt
时间窗: 4 years pre/post policy change
Based on Current Procedural Terminology (CPT) codes abstracted from the Veterans Administration VA Corporate Data Warehouse (CDW)
次要结局
- Change in any emergency department visits(4 years pre/post policy change)
- Change in any non-fatal Overdoses(4 years pre/post policy change)
- Change in the number of emergency department visits(4 years pre/post policy change)
- Change in the number of inpatient admissions(4 years pre/post policy change)
- Change in Fatal Overdoses(4 years pre/post policy change)
- Change in Substance Use(4 years pre/post policy change)
- Change in any inpatient admissions(4 years pre/post policy change)
- Change in the count of non-fatal Overdoses(4 years pre/post policy change)
- Change in Substance Use Relapse(4 years pre/post policy change)