NIA AD/ADRD Health Care Systems Research Collaboratory

NIA AD/ADRD 医疗保健系统研究合作实验室

• 批准号: 10358216
• 负责人: SUSAN L MITCHELL
• 金额: $ 68.4万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10358216
• 关键词: Address; Adherence; Adult; Adverse event; Adverse reactions; Age; Alzheimer' s disease diagnosis; Alzheimer' s disease related dementia; Award; COVID-19; COVID-19 pandemic; COVID-19 vaccination; COVID-19 vaccine; Caregivers; Centers for Disease Control and Prevention (U.S.); Cessation of life; Communication; Contracts; Country; Data; Databases; Dementia; Dependence; Diagnosis; Elderly; Electronic Mail; Enrollment; Ethnic group; Frail Elderly; Funding; Healthcare Systems; Infection; Influenza vaccination; Information Systems; Long-Term Effects; Medicare; Medicare claim; Monitor; Morbidity - disease rate; Neurodegenerative Disorders; Neurologic; Nursing Homes; Persons; Pharmacy facility; Phase; Population; Records; Reminder Systems; Reporting; Research Personnel; Risk; Safety; Sampling; Services; Societies; System; Time; Transportation; Uncertainty; Update; Vaccinated; Vaccination; Vaccines; Virus; adverse event risk; adverse outcome; beneficiary; collaboratory; comorbidity; coronavirus disease; data infrastructure; demented; design; ethnic minority population; experience; logarithm; mortality; mortality risk; population based; programs; racial and ethnic; racial minority; response; seasonal influenza; systems research; vaccine adverse event; vaccine hesitancy; vaccine safety; vaccine trial

ABSTRACT The SARS-CoV-2 pandemic has had a devastating impact on the US population with over 25 million positive cases and over 450,000 deaths as of early February, 2021. In no population has the impact of this virus been more apparent than in the elderly, those with significant co-morbidities and particularly the elderly living with dementia. All population-based analyses find that the risk of mortality increases logarithmically with age. Indeed, even in the frail nursing home population, advanced age has a substantial influence on COVID mortality. Furthermore, a diagnosis of Alzheimer’s Disease and Related Dementias (ADRD) appears to confer an excess risk of morbidity and mortality, whether in a nursing home or not. Fortunately, there are now several vaccines approved for use in adult populations. These not only are highly effective but appear safe. Brown investigators, under a supplement to the NIA funded ADRD IMPACT Collaboratory [3U54AG063546-02S5], have found no increase in short term mortality and no CDC defined significant adverse events among vaccinated nursing home residents. While vaccine supply continues to be locally restricted, major US pharmacies like CVS and Walgreens have been engaged in the vaccination of millions of their customers at their stores around the country beginning the second week of February. In spite of positive data from a population of vaccinated nursing home residents, monitoring rare adverse events requires very large populations which is what this supplemental sample of Walgreens customers represents adding to the CVS Medicare population being studied under the [3U54AG063546-02S7] award. The need for a larger population is particularly important because those with ADRD already suffering from neurodegenerative diseases may be at greater risk of serious neurological adverse events of vaccines. In addition, the unknown potential for adverse events may result in high rates of incomplete vaccination (both shots) among older adults. Such uncertainty contributes to vaccine hesitancy and may result in large disparities in SARS-CoV-2 vaccination among racial/ethnic groups, for which disparities in seasonal influenza vaccination already exist. Incomplete vaccination may be more common among those with ADRD due to dependence on a caregiver for transportation. Since society cannot wait to vaccinate this population with an effective vaccine, we must establish an active post-vaccination surveillance system of a large population to report vaccine safety. This proposal to add Walgreens Pharmacies data to the existing effort to match Pharmacy customer records with Medicare claims to create a data infrastructure that is updated weekly will characterize who is vaccinated, monitor adverse reactions to vaccination and examine the rate of “break through” infection with COVID. Adding data from Walgreen’s 13,231,175 million Medicare beneficiary pharmacy customers allows us to track the immediate and long term effects of vaccination on nearly half the population of Medicare beneficiaries.

摘要 SARS-CoV-2大流行对美国人口产生了破坏性影响， 截至2021年2月初，已有超过45万例病例和45万例死亡。在任何人群中， 比老年人更明显，那些有显著的合并症，特别是老年人生活在 痴呆所有以人口为基础的分析都发现，死亡风险随着年龄的增长而增加。的确， 即使在体弱的疗养院人群中，高龄对COVID死亡率也有重大影响。 此外，阿尔茨海默病和相关痴呆症（ADRD）的诊断似乎赋予了过度的 发病率和死亡率的风险，无论是否在疗养院。 幸运的是，现在有几种疫苗被批准用于成人人群。这些不仅是高度 有效，但看起来安全。布朗调查人员，根据补充NIA资助的ADRD影响， 合作实验室[3U 54 AG 063546 - 02 S5]未发现短期死亡率增加，也未定义CDC 在接种疫苗的疗养院居民中发生的显著不良事件。虽然疫苗供应仍然是 当地限制，美国主要药店，如CVS和沃尔格林一直从事疫苗接种， 从二月的第二周开始，数百万的顾客在全国各地的商店里购物。 尽管来自接种疫苗的养老院居民群体的积极数据， 活动需要非常大的人群，这就是Walgreens客户的补充样本 代表增加了根据[3U 54 AG 063546 - 02 S7]奖励正在研究的CVS Medicare人群。的 需要更大的人口是特别重要的，因为那些与ADRD已经患有 神经退行性疾病可能是疫苗的严重神经系统不良事件的风险更大。在 此外，未知的潜在不良事件可能导致高比例的不完全接种（两次接种） 在老年人中。这种不确定性导致了疫苗的犹豫，并可能导致疫苗接种的巨大差异。 种族/族裔群体之间的SARS-CoV-2疫苗接种，季节性流感疫苗接种的差异 已经存在。不完全疫苗接种在ADRD患者中可能更常见，因为他们依赖于 照顾运输。由于社会迫不及待地为这一人群接种有效的疫苗，我们 必须建立一个大规模人群的疫苗接种后主动监测系统，以报告疫苗安全性。这 建议将Walgreens Pharmacies数据添加到现有工作中，以将药房客户记录与 医疗保险声称要创建一个每周更新的数据基础设施，以描述谁接种了疫苗， 监测疫苗接种的不良反应，并检查新冠病毒“突破”感染率。添加 来自沃尔格林13，231，175万医疗保险受益人药房客户的数据使我们能够跟踪 疫苗接种对近一半的医疗保险受益人的直接和长期影响。