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

COVID-19 大流行期间美沙酮带回家和远程医疗实践变化的范围和影响

• 批准号: 10705259
• 负责人: Jan Gryczynski
• 金额: $ 62.89万
• 依托单位: FRIENDS RESEARCH INSTITUTE, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10705259
• 关键词: Adherence; Administrator; Admission activity; Affect; Area; Behavioral; COVID-19; COVID-19 pandemic; Cessation of life; Clinic; Clinical; Coronavirus; Counseling; Crowding; Data; Death Records; Decision Making; Disparity; Dose; Dropout; Drug usage; Eligibility Determination; Equity; Ethnic Origin; Frequencies; Goals; Health Benefit; Health Services; Health Services Accessibility; Healthcare Systems; Home; Individual; Interruption; Link; Medicine; Methadone; Methods; Modeling; Monitor; Opioid; Outcome; Outpatients; Overdose; Pain; Patient Care; Patient Monitoring; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Policies; Population; Positioning Attribute; Provider; Public Health; Qualifying; Race; Regulation; Relapse; Relaxation; Research; Risk; Series; Shapes; Structure; System; Time; Travel; United States Substance Abuse and Mental Health Services Administration; advanced analytics; analytical method; behavioral health; care delivery; care seeking; combat; coronavirus disease; drug testing; effective therapy; health equity; health practice; indexing; methadone treatment; models and simulation; mortality; novel; opiate tolerance; opioid mortality; opioid overdose; opioid treatment program; opioid use disorder; overdose death; overdose risk; post-COVID-19; predictive modeling; premature; public health emergency; response; risk mitigation; service delivery; sex; telehealth; transmission process; treatment response; trend; willingness

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.

抽象的 美沙酮是治疗阿片类药物使用障碍 (OUD) 的有效方法，在美国通过 专门的阿片类药物治疗计划 (OTP) 自数十年前 OTP 系统诞生以来， 联邦法规要求经常到诊所就诊，以监测患者对治疗的反应和 降低美沙酮转移的风险，患者只能在相当长的时间后“赚取”带回家的美沙酮。 在治疗中，同时展示严格的依从性和稳定性标准，但是，这些经典。 法规没有建立在强有力的经验证据的基础上。 COVID-19 大流行改变了 OTP 的服务提供方式，以减少诊所的拥挤情况。 SAMHSA 监管机构迅速发布监管豁免，赋予 OTP 前所未有的自由裁量权 突然允许带回家的美沙酮剂量和通过远程医疗提供咨询。 对于“不稳定”的患者，最多可服用 14 天的带回家美沙酮；对于“稳定”的患者，最多可服用 28 天的带回家美沙酮。 最近，SAMHSA 重申了监管豁免，并宣布打算寻求永久豁免 然而，需要进行研究来检验这些重大举措的范围和影响。 护理服务的变化。 本研究将 (1) 描述 COVID-19 大流行和发行后 OTP 实践变化的特征 监管豁免，(2) 检查两个主要实践变化的关系（扩展的实际经验） 美沙酮和远程医疗实践）和患者结果，（3）开发预测模型来为决策提供信息 考虑患者何时可以安全地接受带回家而不增加负面结果的风险，以及 (4) 研究扩大的带回家美沙酮与美沙酮过量死亡之间的关系 人口水平。 该研究将使用 BayMark Health Services 的临床和管理数据，BayMark Health Services 是最大的医疗保健提供商 美国 23 个州的 100 个 OTP 门诊治疗将采用先进的分析方法。 回答研究问题，包括多级广义线性混合建模、预测建模 和模拟方法以及中断时间序列所有分析都将考虑行为健康公平性和 检查患者性别、种族和民族方面的差异。 这项研究将为监管机构、OTP 管理者和从业者提供关键数据，并将产生巨大的成果。 支持证据驱动的监管改革的新数据，并可能影响美沙酮治疗的提供 未来十年及以后，COVID-19 大流行和相关的联邦豁免提供了一个机会。 评估长期以来关于美沙酮治疗应如何进行的假设的前所未有的机会 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。