跳至主要内容
临床试验/NCT05028998
NCT05028998招募中不适用

The Impact of COVID-19-related Medication Assisted Treatment Policy Changes on Care and Outcomes for Patients With Opioid Use Disorder

Boston VA Research Institute, Inc.1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
110
试验地点
1
主要终点
Aim 1: Patient-provider encounter

研究概览

简要总结

Our nation is facing the COVID-19 pandemic during an ongoing opioid epidemic. Effective treatment for patients with opioid use problems involves a treatment method called Medication-Assisted Treatment, or MAT. In MAT, patients receive a medication that reduces cravings and withdrawal symptoms and can prevent overdose. Patients also receive counseling. Because the medications that are used in MAT are controlled substances, this treatment is subject to a number of federal regulations. The need for social-distancing during the pandemic would have made following these regulations very difficult for patients and their providers. Because of these difficulties, the federal government eased regulations in March 2020, making it easier for patients to receive MAT with fewer (if any) in-person visits for medication and counseling. Our team is studying the effects of these policy changes on the treatment that patients with opioid use disorder receive and on their outcomes. We are using both quantitative analyses of large, existing databases and qualitative analyses of interviews with patients, providers, and policy-makers to study these effects.

详细描述

The COVID-19 disease outbreak has occurred in the midst of a national opioid crisis, and poses significant risk for individuals with opioid use disorder (OUD). If existing in-person care delivery systems continued, patients would need to choose between risking exposure to the virus, or foregoing OUD treatment. Medication-assisted treatment (MAT), the gold-standard for treating OUD, involves daily medication (i.e., methadone or buprenorphine), close medication monitoring, and counseling sessions, all typically occurring in person. The medications used are schedule II and III controlled substances and are subject to greater federal regulations than medications for other substance use disorders (SUD), such as alcohol use disorder (AUD).3 To temper the impact of COVID-19 on OUD patients, in March 2020 the federal government temporarily, but dramatically, loosened MAT restrictions to expand treatment options, require fewer in-person visits, and prevent disruption to life-saving treatment.

This rapid shift in policy created a natural experiment, allowing for the evaluation of this MAT policy intervention on OUD patient care and outcomes. To examine the unknown effects of this intervention, we propose a mixed-methods, naturalistic experimental design involving quantitative analysis of large administrative and healthcare utilization datasets to evaluate the impact of MAT policy changes on patient care and outcomes. We will also compare OUD patient outcomes to those of AUD patients (analogue comparison group), for whom treatment was unaffected by MAT policy changes. We will then conduct interviews with patients, providers, and key MAT policy stakeholders, to understand perspectives on the impact of these COVID-19 related MAT policy changes on the lives and well-being of OUD patients, and guide policy decisions regarding whether or not to make these changes permanent. Given the general impact of the COVID-19 pandemic on patients and systems, we will compare outcomes for patients with OUD to analogue AUD patients, for whom there were no comparable medication policy changes in response to COVID-19.

Patients with OUD across three healthcare systems will be engaged in all steps of the research, including influencing the research design, assisting in determining key variables for Aims 1 and 2, collaborating in drafting our interview scripts for Aim 3, and assisting in interpreting our results and disseminating findings to patient stakeholders.

Aim 1. Using existing datasets, examine the effect of federal regulation changes on trends in delivery of MAT for OUD before and after pandemic onset, with a particular focus on prescription access, refills, and dosing schedules, as well as rates of in-person vs. telehealth medical and counseling visits.

Aim 2. Estimate the impact of the changes in OUD healthcare delivery on crucial patient outcomes (e.g., emergency department visits, detoxification, treatment retention, relapse, overdose, and mortality) by comparing patients with OUD vs. AUD (clinical analogue comparison group), across time (pre- and post-MAT policy changes).

研究设计

研究类型
Observational
观察模型
Case Control
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

入选标准

  • VA patients with OUD who currently, or recently (within the past 6 months) receive(d) treatment for OUD from providers within Veterans Health Administration in the states of Massachusetts, Rhode Island, or New Hampshire.
  • Non-Veteran patients with OUD (N=30) who currently, or recently (within the past 6 months) receive(d) treatment for OUD from providers outside Veterans Health Administration in the states of Massachusetts, Rhode Island, or New Hampshire.
  • VA - OUD treatment providers who currently provide treatment for OUD within Veterans Health Administration, and have been a Veterans Health Administration provider of OUD treatment for at least one year in Massachusetts, Rhode Island, or New Hampshire.
  • Non-VA OUD treatment providers who currently provide treatment for OUD outside of Veterans Health Administration, and have been a provider of OUD treatment for at least one year in Massachusetts, Rhode Island, or New Hampshire.
  • OUD treatment and policy decision-makers who currently or recently (within past 6 months) hold/held positions within federal, state, or private organizations (e.g., Veterans Health Administration, SAMHSA) in which they are responsible for making and/or influencing significant decisions regarding the OUD treatment policy and/or the manner in which these are implemented.

排除标准

  • Inability to speak fluent English
  • Inability to provide a clear reporting of their experiences due to current influence of substances

结局指标

主要结局

Aim 1: Patient-provider encounter

时间窗: January 2019-December 2019; April 2020-March 2021

In-person counseling / psychotherapy, Telehealth counseling/ psychotherapy for OUD and AUD (clinical comparator)

Aim 2: Treatment retention/discontinuation

时间窗: January 2019-December 2019; April 2020-March 2021

Medication treatment retention, as measured by continuous and treatment, for patients with OUD and AUD (comparator)

Aim 1: Prescription medication access

时间窗: January 2019-December 2019; April 2020-March 2021

Medication prescription fills, In-person prescribing, Telehealth prescribing for OUD and AUD (clinical comparator)

Aim 2: Adverse outcomes

时间窗: January 2019-December 2019; April 2020-March 2021

Emergency Department visits, Detoxification treatment utilization, Overdose, Death, OUD/AUD Relapse for OUD and AUD (clinical comparator)

Aim 3: Semi-structured qualitative interview data from patients, providers, policy makers

时间窗: January 2019-December 2019; April 2020-March 2021

\[Qualitative\] Patient, provider, and policy-maker perspectives regarding OUD treatment and OUD treatment policies, practices, and implementation during COVID-19

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验