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.

项目概要 在 COVID-19 公共卫生紧急事件 (PHE) 期间做出的监管变化放宽了采取措施的标准 美沙酮的家庭给药 (THD) 提供了通过挽救生命的治疗来提高护理保留率的机会。 美沙酮是一种治疗阿片类药物使用障碍 (OUD) 的高效药物，以阿片类药物形式提供 治疗计划 (OTP)。然而，长期的监管限制也限制了美沙酮的供应 由于需要频繁去诊所，因此产生了沉重负担的要求。这些的理由 法规的目的是防止美沙酮的转移和过量服用。然而，历史和应用 美沙酮法规的出台源于对 OUD 患者的污名化和种族主义观念。大多数 OTP 是 位于以黑人/非裔美国人或拉丁裔人口为主的社区内。最后， 黑人/非裔美国人和拉丁裔人士比其他受限制较少的人更容易获得美沙酮 OUD 药物。在 OTP 内，黑人/非裔美国人和拉丁裔人士不太可能获得 足够的美沙酮剂量，并且比非西班牙裔白人客户的保留率较低。更灵活 THD 可能有助于解决护理方面的差异。目前，全国范围内正在就平衡安全展开辩论 人们担心更灵活的 THD 会损害客户保留率和生活质量。 THD 低 许多 OTP 表明需要新的数据驱动干预措施来鼓励根深蒂固的临床变化 工作流程和长期以来对 OUD 客户的污名化信念。 OTP领导和员工表达担忧 关于滥用监管灵活性、更大 THD 的医源性影响以及来自 服用过量或转移。最后，对于长期立足其业务的组织来说，财务问题日益严重 频繁亲自配药的计费模型。该项目源于一个完善的 纽约州成瘾服务和支持办公室之间的学术-公共合作伙伴关系 （OASAS）以及来自纽约大学、康奈尔大学和纽约大学的研究合作者 康涅狄格州。我们提出了一个两阶段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 变化以及 THD 的财务障碍。干预措施将包括来自 OTP THD 的特定仪表板 多个国家数据库。该方法将遵循健康公平实施框架。在 第 1 阶段 (R61)，我们将采用解释性顺序混合方法设计来结合大型分析 州行政数据库——医疗补助、治疗登记、THD 报告——以及定性访谈 细化干预。在第 2 阶段 (R33)，我们将使用 36 个 OTP（约 10,800 医疗补助客户/年）随机分为 6 个队列，在三年内进行为期六个月的临床水平干预。这 试验将测试干预措施对 1) THD 的影响； 2) 保留护理； 3) 不良医疗事件。 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。