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: 10539988
• 负责人: Jan Gryczynski
• 金额: $ 53.78万
• 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/10539988
• 关键词: Adherence; Administrator; Admission activity; Affect; Area; Behavioral; COVID-19; COVID-19 pandemic; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinic; Clinical; Coronavirus; Counseling; Crowding; Data; Death Records; Decision Making; Dose; Dropout; Drug usage; 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; Race; Regulation; Relapse; 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; 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; 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 美沙酮是阿片类药物使用障碍（OUD）的有效治疗方法 专门的阿片类药物治疗计划（OTP）。自从几十年前的OTP系统成立以来， 联邦法规需要经常出席诊所才能监测患者对治疗的反应和 降低方法adone转移的风险。大量时间后，患者只能“赚取”带回家的方法adone 在治疗中，同时证明了依从性和稳定性的刚性标准。但是，这些经典 法规并非基于有力的经验证据。 COVID-19大流行在OTPS上转变了服务提供实践。为了减少诊所的拥挤， SAMHSA监管机构迅速颁发了监管豁免，使OTP提供了前所未有的酌处权 带纳米酮剂量并通过远程医疗提供咨询。突然允许OTP分配 “较不稳定”的患者最多可容纳14天的纳入式方法，而“稳定”患者的28天。更多的 最近，SAMHSA重申了监管豁免，并宣布了购买永久性的意图 OTP的监管改革。但是，需要研究来检查这些主要的范围和影响 护理交付的变化。 这项研究将（1）表征COVID-19大流行和发行后OTP的实践变化。 监管豁免，（2）检查两个主要实践变化的关系（扩大的带回家 Methodadone和远程医疗实践）和患者结果，（3）开发一个预测模型，以告知决策 - 制作何时可以安全地接受接受家庭而不会增加负面结果的风险，并且 （4）检查在一个 人口水平。 该研究将使用Baymark Health Services的临床和行政数据，Baymark Health Services是最大的提供商 在美国门诊OUD治疗，在23个州有100个OTP。将应用高级分析方法 回答研究问题，包括多级广义线性混合建模，预测建模 和仿真方法和中断时间序列。所有分析将考虑行为健康平等和 检查有关患者的性别，种族和种族的分布。 这项研究将为监管机构，OTP管理员和从业者提供关键数据。它将很高 支持证据驱动的监管改革的新数据，并可以塑造Meadadone治疗的交付 接下来的十年及以后。 COVID-19-19大流行和相关联邦豁免提供 空前的机会来评估有关方法酮应如何处理的长期以来的假设 旨在最大程度地提高其利益，同时保护患者和公众免受意外伤害。