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.

摘要 美沙酮是治疗阿片类药物使用障碍(OUD)的有效药物，在美国通过 专门的阿片治疗方案(OTP)。自几十年前OTP系统问世以来， 联邦法规要求频繁的诊所就诊以监测患者对治疗的反应和 减少美沙酮转移的风险。患者只能在相当长的时间后才能获得带回家的美沙酮 在治疗中，同时展示了严格的坚持和稳定标准。然而，这些经典的 监管并没有建立在强有力的经验证据基础上。 新冠肺炎大流行改变了OTP的服务交付做法。为了减少诊所的拥挤， SAMHSA监管机构迅速发布了监管豁免，赋予OTPS前所未有的自由裁量权，以提供 带回家的美沙酮剂量，并通过远程健康提供咨询。OTP突然被允许分发 “不稳定”患者最多可服用14天美沙酮，“稳定”患者最多可服用28天美沙酮。更多 最近，SAMHSA重申了监管豁免，并宣布打算寻求永久 OTP的监管改革。然而，需要进行研究来检查这些主要疾病的范围和影响。 护理服务的变化。 这项研究将(1)描述在新冠肺炎大流行和发布后OTP的做法变化 关于监管豁免，(2)检查两个主要实践变化(扩大后的收益)之间的关系 美沙酮和远程医疗实践)和患者结局，(3)开发预测模型，为决策提供信息- 在不增加负面结果风险的情况下，患者何时可以安全地接受带回家的治疗，以及 (4)研究美沙酮与美沙酮过量死亡之间的关系 人口水平。 这项研究将使用来自BayMark Health Services的临床和管理数据，BayMark Health Services是 门诊病人在美国接受治疗，在23个州有100个OTP。将应用先进的分析方法 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，以及间断时间序列。所有分析都将考虑行为健康公平性和 检查患者的性别、种族和民族方面的差异。 这项研究将为监管机构、OTP管理员和从业者提供关键数据。它的收益率会很高。 支持循证监管改革的新数据，并可能影响美沙酮治疗的提供 在接下来的十年和更长时间里。新冠肺炎大流行和相关的联邦豁免提供了 史无前例的机会来评估关于美沙酮治疗方法的长期假设 其结构旨在最大化其好处，同时保护患者和公众免受意外伤害。