Scope and impact of methadone take-home and telehealth practice changes during the COVID-19 pandemic

摘要 美沙酮是阿片类药物使用障碍（OUD）的有效治疗方法，在美国通过以下方式提供： 专门的阿片类药物治疗计划（OTP）。检察官办公室制度自几十年前建立以来， 联邦法规要求经常到诊所就诊，以监测患者对治疗的反应， 减少美沙酮转作他用的风险。患者只能在很长一段时间后“赚取”带回家的美沙酮 在治疗中，同时证明了严格的依从性和稳定性标准。然而，这些经典 监管没有强有力的经验证据为基础。 COVID-19疫情改变了在线旅行社的服务提供方式。为了减少诊所的拥挤， SAMHSA监管机构迅速发布了监管豁免，给予OTP前所未有的自由裁量权， 将美沙酮剂量带回家，并通过远程保健提供咨询。OTP突然被允许分发 对于“不太稳定”的患者，最多14天的美沙酮带回家，对于“稳定”的患者，最多28天。更 最近，SAMHSA重申了监管豁免，并宣布打算寻求永久性的 对在线旅行社的监管改革。然而，需要进行研究，以审查这些主要措施的范围和影响。 改变护理服务。 本研究将（1）描述COVID-19大流行和发行 监管豁免，（2）审查两个主要的做法变化（扩大带回家的关系 美沙酮和远程医疗实践）和患者结果，（3）开发预测模型，为决策提供信息- 了解患者何时可以安全地接受带回家，而不会增加负面结果的风险，以及 (4)研究扩大带回家美沙酮和美沙酮过量死亡之间的关系， 人口水平。 该研究将使用来自BayMark Health Services的临床和管理数据，BayMark Health Services是最大的医疗服务提供商。 在美国的门诊治疗，在23个州有100个OTP。将采用先进的分析方法 回答研究问题，包括多水平广义线性混合建模、预测建模 和模拟方法，以及中断的时间序列。所有分析都将考虑行为健康公平性， 检查患者性别、种族和民族的差异。 这项研究将为监管机构，OTP管理员和从业人员提供关键数据。它的产量会很高 新的数据，以支持证据驱动的监管改革，并可能塑造美沙酮治疗提供超过 下一个十年及以后。COVID-19大流行和相关的联邦豁免提供了 这是一个前所未有的机会，可以评估长期以来关于美沙酮治疗应该如何 其结构旨在最大限度地发挥其效益，同时保护患者和公众免受意外伤害。

Abstract Methadone is an effective treatment for opioid use disorder (OUD) that is delivered in the U.S. through specialized Opioid Treatment Programs (OTPs). Since the inception of the OTP system many decades ago, federal regulations have required frequent clinic attendance to monitor patients’ response to treatment and reduce the risks of methadone diversion. Patients can only ‘earn’ take-home methadone after significant time in treatment while demonstrating rigid standards for adherence and stability. However, these classic regulations are not grounded in strong empirical evidence. The COVID-19 pandemic transformed service delivery practices at OTPs. To reduce crowding in clinics, SAMHSA regulators swiftly issued regulatory exemptions that gave OTPs unprecedented discretion to provide take-home methadone doses and deliver counseling via telehealth. OTPs were suddenly permitted to dispense up to 14 days of take-home methadone for ‘less stable’ patients, and 28 days for ‘stable’ patients. More recently, SAMHSA reaffirmed the regulatory exemptions and announced intentions to pursue permanent regulatory reform for OTPs. However, research is needed to examine the scope and impact of these major changes to care delivery. This study will (1) characterize practice changes at OTPs following the COVID-19 pandemic and the issuance of regulatory exemptions, (2) Examine the relationship of two major practice changes (expanded take-home methadone and telehealth practices) and patient outcomes, (3) develop a prediction model to inform decision- making about when patients can safely receive take-homes without increasing risk of negative outcomes, and (4) examine the relationship between expanded take-home methadone and methadone overdose deaths at a population level. The study will use clinical and administrative data from BayMark Health Services, the largest provider of outpatient OUD treatment in the U.S., with 100 OTPs in 23 states. Advanced analytical methods will be applied to answer the research questions, including multilevel generalized linear mixed modeling, predictive modeling and simulation methods, and interrupted time series. All analyses will consider behavioral health equity and examine disparities with respect to patients’ sex, race, and ethnicity. This study will provide critical data for regulators, OTP administrators, and practitioners. It will yield highly novel data to support evidence-driven regulatory reform, and could shape methadone treatment delivery over the next decade and beyond. The COVID-19 pandemic and associated federal exemptions offer an unprecedented opportunity to evaluate long-held assumptions about how methadone treatment should be structured to maximize its benefits while safeguarding patients and the public from unintended harm.