Prescribing trends and associated outcomes of antiepileptic drugs and other psychoactive medications in US nursing homes surrounding the COVID-19 pandemic

自2012年推出改善痴呆症护理的国家伙伴关系以来，CMS几乎审查了所有相关的长期精神活性处方，目标是减少阿尔茨海默病和/或阿尔茨海默病相关痴呆(AD/ADRD)患者的抗精神病药物使用。虽然这些受监测的精神活性药物的长期使用有所下降，但稳定情绪的抗癫痫药物(AEDs)的处方却增加了。与抗精神病药物类似，稳定情绪的AEDs也用于治疗AD/ADRD人群中痴呆症(BPSD)的行为和心理症状。与抗精神病药物和其他精神活性药物不同，疗养院开出的AEDs不是强制向CMS报告的。初步研究表明，AED的增加完全集中在AD/ADRD和其他没有癫痫诊断的痴呆症患者中，并有目的地将BPSD作为抗精神病药物的一种未监测的替代药物。AEDs未被批准用于治疗AD/ADRD或任何痴呆症症状，疗效证据薄弱，并传递严重风险。越来越多地，该伙伴关系的首次亮相似乎是一个转折点，不受监控的替代药物治疗AD/ADRD症状的趋势急剧增加。此外，初步研究结果表明，COVID大流行是第二个拐点，目前向治疗AD/ADRD的非优势但未报告的药物的过渡正在再次迅速加速。与这种不断演变的预标现象相关的所有结果仍然未知，尽管早期数据警告称，危害可能会增加，而不会带来好处。 我们提出了一项回顾分析，详细说明了针对AD/ADRD和其他疾病的所有精神活性药物(包括AEDs)的长期处方，这种处方在大流行和有针对性的减少工作的综合压力下是如何变化的，以及这种处方在不良健康后果中的作用。我们将通过创建2009-2021年养老院居民(包括AD/ADRD患者)季度队列的详细数据集来实现这一点，该数据集利用CMS的最小数据集(MDS)、D部分、MedPAR和公共使用文件中在单个级别链接的元素。最终的关联数据集将包括健康、人口统计学、认知和诊断变量、所有精神活性药物声明、疗养院结果、医院和急诊室不良事件记录以及长期设施详细信息，包括人力资源和COVID统计数据。最后，为了帮助解释和验证研究结果，将对疗养院处方医生的全国抽样进行调查，了解他们对AD/ADRD护理方法的变化及其相关结果的知识和信念。这项研究将描述疗养院目前和发展中的所有适应症的AED使用情况，重点是AD/ADRD和AD/ADRD的结果。它将描述接受或不接受精神活性药物治疗的长期逗留人口中的种族和性别差异。它将结合关于ADRD管理和成果的国家政策来描述COVID大流行的影响。这项研究的结果将为政策制定者提供信息，改善养老院护理和安全，并为正在进行的研究引入新的途径。

Since the National Partnership to Improve Dementia Care debuted in 2012 with the goal to reduce antipsychotic use in individuals with Alzheimer’s disease and/or Alzheimer’s-related dementias (AD/ADRD), CMS has scrutinized almost all associated long-stay psychoactive prescribing. While the long-stay use of these monitored psychoactive drugs has declined, prescriptions of mood-stabilizing antiepileptic drugs (AEDs) have increased. Similar to antipsychotics, mood stabilizing AEDs are used to treat the behavioral and psychological symptoms of dementia (BPSD) in the AD/ADRD population. Unlike antipsychotics and other psychoactive medications, AEDs prescribed in nursing homes are not mandatorily reported to CMS. Pilot studies suggest AED increases are concentrated entirely in AD/ADRD and other dementia patients with no diagnosis of epilepsy and purposefully prescribed for BPSD as an unmonitored alternative to antipsychotics. AEDs are not approved to treat AD/ADRD or any dementia symptoms, have weak efficacy evidence, and convey serious risk. Increasingly, the Partnership’s debut seems an inflection point where the trend toward unmonitored alternative drugs for AD/ADRD symptoms sharply increased. Furthermore, initial findings hint that the COVID pandemic represents a second critical point of inflection where the existing transition toward non-superior but unreported drugs for AD/ADRD is again rapidly accelerating. All outcomes associated with this evolving pre-scribing phenomenon remain unknown, though early data warns that harms may be increasing without benefit. We propose a retrospective analysis detailing long-stay prescribing of all psychoactives, including AEDs, for AD/ADRD and other conditions, how such prescribing is changing under the combined pressures of the pandemic and targeted reduction efforts, and the role of such prescribing in adverse health outcomes. We will accomplish this by creating a detailed dataset of quarterly cohorts of nursing home residents, including those with AD/ADRD, for the years 2009-2021 that draws on elements linked at an individual level from CMS’s Minimum Data Set (MDS), Part D, MedPAR, and Public Use files. The final linked dataset will include health, demographic, cognitive, and diagnostic variables, all psychoactive drug claims, nursing home outcomes, records of hospital and ER adverse events, and long-stay facility details, including staffing resources and COVID statistics. Finally, to help explain and validate findings, a national sampling of nursing home prescribers will be surveyed regarding their knowledge and beliefs surrounding changing approaches to the care of AD/ ADRD and associated outcomes. This study will describe current and evolving AED use in nursing homes for all indications, focusing on AD/ADRD and AD/ADRD outcomes. It will describe racial and gender disparities in the long-stay populations treated or not treated with psychoactives. It will delineate the impact of the COVID pandemic in combination with national policies on ADRD management and outcomes. Results of this study will inform policymakers, improve nursing home care and safety, and introduce new avenues for ongoing research.