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 新冠肺炎突发公共卫生事件期间做出的监管变化，放宽了服用- 美沙酮的家庭剂量(THD)提供了一个机会，通过挽救生命的治疗来改善护理中的保留率。 美沙酮是一种治疗阿片类药物使用障碍的高效药物，由阿片类药物提供。 治疗计划(OTP)。然而，长期的监管限制也限制了美沙酮的供应。 AS要求经常去诊所，从而产生了沉重的客户负担。这样做的理由是 规定是为了防止美沙酮的转移和过量。然而，它的历史和应用 对美沙酮的监管源于对患有OUD的人的污名化和种族主义观念。大多数OTP都是 位于以黑人/非裔美国人或拉丁裔人口为主的社区内。因此， 黑人/非裔美国人和拉丁裔人比其他人更容易获得美沙酮， 给乌德吃的药。在OTPS中，黑人/非裔美国人和拉丁裔个人不太可能获得 与非西班牙裔白人客户相比，美沙酮的剂量适中，保留率较低。更灵活 THD可能有助于解决护理方面的差异。目前，有一场关于平衡安全的全国性辩论 对更灵活的THD与客户保留和生活质量的好处的担忧。THD的低价供应 在许多OTP中，建议需要新的数据驱动的干预措施，以鼓励深入临床的变化 工作流程和长期以来对OUD客户的污名化看法。OTP领导层和员工表示关切 关于滥用监管灵活性，更大的THD的医源性影响，以及 吸毒过量或转移注意力。最后，对于长期以业务为基础的组织来说，财务方面的担忧加剧 关于经常亲自配药的计费模型。这个项目源于一个久负盛名的 纽约州成瘾服务办公室和Support之间的学术-公共合作伙伴关系 (OASAS)和来自纽约大学、康奈尔大学和加州大学的研究合作者 康涅狄格州。我们提出了一个分两个阶段的项目，以开发并测试多维OTP干预 解决临床决策、监管混乱、法律责任问题、临床实践能力 变化，以及THD的资金障碍。干预将包括OTP THD特定的仪表板，这些仪表板来自 多个州数据库。这一方法将由卫生公平执行框架提供信息。在……里面 阶段1(R61)，我们将使用解释性顺序混合方法设计来结合分析大型 州行政数据库-医疗补助、治疗登记、THD报告-通过定性访谈 完善干预措施。在第2阶段(R33)，我们将对36个OTP(~10,800)进行阶梯式楔形试验 医疗补助客户/年)随机分成6个队列，在三年内进行为期六个月的临床水平干预。这个 试验将测试干预对1)THD；2)保留在护理中；以及3)不良医疗事件的影响。 我们将具体检查干预对黑人/非洲裔美国人和拉丁裔客户的影响。