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: 10878304
• 负责人: Yuhua Bao
• 金额: $ 114.61万
• 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 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10878304
• 关键词: Leveraging; regulatory; flexibility; methadone; take

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 在COVID-19-19期间进行的监管变更（PHE）放宽了标准 Metagadone的家用剂量（THD）提供了一个机会，可以通过救生治疗来改善保留率。 美沙酮是用于治疗Ooid使用障碍（OUD）的高效药物 治疗计划（OTP）。然而，长期的监管限制也限制了方法adone的可用性 由于创造了伯恩客户经常去诊所的要求，因此伯恩伯恩客户的需求量很大。这些理由 法规是为了防止转移和过量服药免受Metagadone的影响。但是，历史和应用 Metagadone法规源于OUD患者的污名化和种族主义笔记。大多数OTP是 位于主要是黑人/非裔美国人或拉丁裔人群的社区内。最后， 黑人/非洲裔美国人和拉丁裔人比其他限制更大的人可以使用Metagadone， Oud的药物。在OTP中，黑人/非裔美国人和拉丁裔人不太可能接受 与非西班牙裔白人客户相比，方法载体的足够剂量水平和保留率较低。更灵活 THD可能有助于解决护理中的分布。目前，关于平衡安全的全国性辩论 担心对客户保留和生活质量的好处更灵活。低提供的THD 在许多OTP中，需要采取新的数据驱动干预措施来鼓励内心临床的变化 工作流和关于Oud客户的长期污名化信念。 OTP领导力和员工表示关注 关于误用监管灵活性，更大THD的息肉作用以及有关法律责任的责任 过量服用或转移。最后，对长期以来基于业务的组织的财务问题 用于计费的模型，以进行经常面对面的药物分配。这个项目从一个良好的 成瘾服务办公室与支持 （OASA）和纽约大学，康奈尔大学和大学的研究合作者 康涅狄格州。我们提出了一个基于两步的项目来开发，然后测试多维OTP干预措施 解决临床决策，监管混乱，法律责任问题，临床实践能力 变更和财务障碍。干预措施将包括从中绘制的特定仪表板 多个状态数据库。该方法将由健康公平实施框架告知。在 第1阶段（R61），我们将采用爆炸性​​顺序混合方法设计来结合大型分析 国家行政数据库（Medicaid，治疗登记册，THD报告）以及定性访谈 完善干预措施。在第2阶段（R33）中，我们将使用36个OTP进行阶梯窗格试验（〜10,800 医疗补助客户/年）在三年内随机分为6个月的诊所级干预六个同类。这 试验将测试干预对1）TH的影响； 2）保留护理； 3）不利的医疗事件。 我们将专门研究干预措施对黑人/非裔美国人和拉丁裔客户的影响。