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.

摘要