Leveraging regulatory flexibility for methadone take-home dosing to improve retention in treatment for opioid use disorder: A stepped-wedge randomized trial to facilitate clinic level changes

利用美沙酮带回家剂量的监管灵活性来提高阿片类药物使用障碍治疗的保留率：一项促进临床水平变化的阶梯式楔形随机试验

• 批准号: 10590040
• 负责人: Yuhua Bao
• 金额: $ 59.88万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 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 2023-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10590040
• 关键词: Address; Adverse event; Affect; African American; Attitude; Behavior; Belief; Black race; Businesses; COVID-19; Caring; Client; Clinic; Clinical; Communities; Confusion; Connecticut; Data; Databases; Development; Dose; Emergency department visit; Equilibrium; Ethnic Origin; Event; Healthcare; Home; Hospitalization; Iatrogenesis; Incentives; Individual; Intervention; Interview; Latinx; Latinx population; Leadership; Legal Liability; Medicaid; Methadone; Methods; Modeling; Monitor; New York; Not Hispanic or Latino; Outcome; Overdose; Persons; Pharmaceutical Preparations; Phase; Quality of life; Race; Randomized; Recording of previous events; Registries; Regulation; Relaxation; Reporting; Research; Safety; Services; Stigmatization; System; Testing; Universities; Variant; Visit; addiction; administrative database; adverse outcome; base; clinical decision-making; clinical practice; cohort; dashboard; design; experience; flexibility; health care disparity; health equity; implementation framework; improved; intervention effect; intervention program; methadone treatment; mortality; opioid treatment program; opioid use disorder; payment; programs; public health emergency; randomized trial; stem; waiver

Project Summary Regulatory changes made during the COVID-19 public health emergency (PHE) that relaxed criteria for take- home dosing (THD) of methadone offer an opportunity to improve retention in care with a lifesaving treatment. Methadone is a highly effective medication for treating opioid use disorders (OUD) that is provided in opioid treatment programs (OTPs). Yet, longstanding regulatory restrictions limit the availability of methadone as well as create demands that heavily burden clients by requiring frequent visits to clinics. The rationale for these regulations is to safeguard against diversion and overdoses from methadone. Yet, the history and application of methadone regulations stem from stigmatized and racist notions of people with OUD. Most OTPs are located within communities with predominantly Black/African American or Latinx populations. Consequently, Black/African American and Latinx individuals have greater access to methadone than other, less restricted, medications for OUD. Within OTPs, Black/African American and Latinx individuals are less likely to receive adequate dosing levels of methadone and have lower retention than non-Hispanic White clients. More flexible THD may help address disparities in care. Currently, there is a national debate about balancing safety concerns over more flexible THD against the benefits of client retention and quality of life. Low offering of THD in many OTPs suggests a need for new data-driven interventions to encourage changes in engrained clinical workflows and long-standing stigmatizing beliefs about OUD clients. OTP leadership and staff express concern about misapplying regulatory flexibility, of iatrogenic effects of greater THD, and about legal liability from overdoses or diversion. Finally, financial concerns mount for organizations that have long based their business models on billing for frequent in-person medication dispensing. This project stems from a well-established academic-public partnership in New York State between the Office of Addiction Services and Supports (OASAS) and research collaborators from New York University, Cornell University, and the University of Connecticut. We propose a two-phased project to develop then test a multidimensional OTP intervention to address clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to THD. The intervention will include OTP THD specific dashboards drawn from multiple State databases. The approach will be informed by the Health Equity Implementation Framework. In phase 1 (R61), we will employ an explanatory sequential mixed method design to combine analysis of large state administrative databases—Medicaid, treatment registry, THD reporting—with qualitative interviews to refine the intervention. In phase 2 (R33), we will conduct a stepped-wedge trial with 36 OTPs (~10,800 Medicaid clients/yr) randomized to 6 cohorts of a six-month long clinic-level intervention over three years. The trial will test the effects of the intervention on 1) THD; 2) retention in care; and 3) adverse healthcare events. We will specifically examine the effects of the intervention for Black/African American and Latinx clients.

项目摘要 2019冠状病毒病突发公共卫生事件（PHE）期间，放宽了服用标准的监管变化- 美沙酮家庭给药（THD）提供了一个机会，以改善保留在护理与挽救生命的治疗。 美沙酮是一种治疗阿片类药物使用障碍（OUD）的高效药物， 治疗方案（OTP）。然而，长期的监管限制也限制了美沙酮的可用性 由于需要经常去诊所，这造成了给客户带来沉重负担的需求。这些理由 有关规例旨在防止美沙酮被转用或过量服用。然而，历史和应用 美沙酮法规的制定源于对OUD患者的污名化和种族主义观念。大多数OTP 位于以黑人/非洲裔美国人或拉丁裔人口为主的社区。因此，委员会认为， 黑人/非裔美国人和拉丁美洲人比其他人更容易获得美沙酮，限制较少， 治疗OUD的药物在OTP中，黑人/非洲裔美国人和拉丁裔人不太可能获得 美沙酮的剂量水平足够，并且保持率低于非西班牙裔白色客户。更灵活 THD可能有助于解决护理方面的差异。目前，全国正在讨论如何平衡安全性 对更灵活的THD的关注，对客户保留和生活质量的好处。低THD 在许多OTP中，这表明需要新的数据驱动的干预措施，以鼓励改变根深蒂固的临床 工作流程和长期以来对OUD客户的污名化信念。检察官办公室领导和工作人员表示关切 关于滥用监管灵活性，更大的THD的医源性影响，以及关于法律的责任 吸毒过量或转移注意力最后，长期以来， 为频繁的亲自配药计费的模型。该项目源于一个完善的 纽约州戒毒服务和支持办公室之间的学术-公共伙伴关系 （OASAS）和来自纽约大学、康奈尔大学和纽约大学的研究合作者 康涅狄格我们提出了一个两阶段的项目，开发然后测试多维OTP干预， 解决临床决策、监管混乱、法律的责任问题、临床实践能力 变化和THD的财政障碍。干预措施将包括OTP THD专用仪表板， 多个国家数据库。这一方法将以《卫生公平执行框架》为依据。在 第一阶段（R61），我们将采用解释性序贯混合方法设计，将联合收割机分析 国家行政数据库-医疗补助，治疗登记，THD报告-与定性访谈， 完善干预措施。在第2阶段（R33），我们将在36名OTP（约10，800名）中进行阶梯楔形试验 医疗补助客户/年）随机分为6个队列，为期6个月，为期3年的临床干预。的 试验将测试干预对1）THD的影响; 2）保持护理;和3）不良医疗事件。 我们将专门研究干预对黑人/非洲裔美国人和拉丁美洲客户的影响。