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

COVID-19 大流行期间美国疗养院抗癫痫药物和其他精神活性药物的处方趋势和相关结果

• 批准号: 10446265
• 负责人: Jonathan David Winter
• 金额: $ 70.21万
• 依托单位: VIRGINIA COMMONWEALTH UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10446265
• 关键词: Adverse event; Alzheimer' s Disease; Alzheimer' s disease care; Alzheimer' s disease related dementia; Antiepileptic Agents; Antipsychotic Agents; Attitude; Behavior; Behavioral Symptoms; Belief; Black race; COVID-19 pandemic; Caring; Cessation of life; Characteristics; Cognitive; Data; Data Set; Dementia; Diagnosis; Diagnostic; Drug Prescriptions; Drug usage; Elements; Emergency department visit; Epilepsy; Event; Goals; Health; Home Nursing Care; Hospital Records; Hospitalization; Individual; Knowledge; Label; Link; Measures; Medical; Methods; Monitor; Moods; National Institute on Aging; Nursing Homes; Outcome; Patients; Pattern; Pharmaceutical Preparations; Pilot Projects; Planning Theory; Policies; Population; Prevalence; Psychotropic Drugs; Research; Resources; Risk; Role; Safety; Sampling; Surveys; Symptoms; Vulnerable Populations; base; cohort; coronavirus disease; dementia care; falls; gender disparity; hospice environment; improved; innovation; neuropsychiatric symptom; palliative; pandemic disease; pandemic stress; patient oriented; pressure; psychological symptom; racial disparity; response; statistics; stressor; trend

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.

自 2012 年国家改善痴呆症护理合作伙伴关系首次启动以来，其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，CMS 审查了几乎所有相关的长期精神药物处方。这些受监测的精神活性药物的长期使用有所减少，稳定情绪的抗癫痫药物 (AED) 的处方有所增加，与抗精神病药物类似，情绪稳定药物的处方有所增加。稳定 AED 用于治疗 AD/ADRD 人群中的痴呆症行为和心理症状 (BPSD)。与抗精神病药物和其他精神活性药物不同，疗养院开出的 AED 并不强制报告给 CMS。试点研究表明，AED 的增加完全是集中的。在未诊断出癫痫的 AD/ADRD 和其他痴呆患者中，特意为 BPSD 作为抗精神病药物的不受监控的替代药物，未获批准用于治疗 AD/ADRD 或 AD/ADRD。该合作伙伴关系的首次亮相似乎是一个转折点，针对 AD/ADRD 症状使用不受监控的替代药物的趋势急剧增加。拐点的关键点是，现有的 AD/ADRD 药物向非优质但未报告的药物的转变再次迅速加速，与这种不断发展的处方现象相关的所有结果仍然未知，尽管早期数据警告说这会造成危害。可能会增加但没有任何好处。 我们提出一项回顾性分析，详细说明所有精神活性药物（包括 AED）用于治疗 AD/ADRD 和其他病症的长期处方，在大流行和有针对性的减少努力的综合压力下，此类处方是如何变化的，以及此类处方在不良反应中的作用我们将通过创建 2009-2021 年疗养院居民季度队列的详细数据集（包括 AD/ADRD 患者）来实现这一目标，该数据集利用了个人层面上的相关元素CMS 的最小数据集 (MDS)、D 部分、MedPAR 和公共使用文件将包括健康、人口统计、认知和诊断变量、所有有效的精神药物声明、疗养院结果、医院记录和急诊室不良反​​应。最后，为了帮助解释和验证研究结果，将对全国疗养院处方者进行调查，了解他们对改变 AD/ADRD 护理方法的知识和信念。以及相关的结果。这项研究将描述疗养院当前和不断发展的 AED 使用情况，重点关注 AD/ADRD 和 AD/ADRD 结局。它将描述接受或未接受精神药物治疗的长期住院人群的种族和性别差异。新冠疫情大流行的影响以及国家政策对 ADRD 管理和结果的影响，这项研究的结果将为政策制定者提供信息，改善疗养院的护理和安全，并为正在进行的研究引入新的途径。