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: 10285112
• 负责人: SUSAN L MITCHELL
• 金额: $ 27.32万
• 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/10285112
• 关键词: 2019-nCoV; Adverse effects; Adverse reactions; Alzheimer' s disease related dementia; Assisted Living Facilities; COVID-19; COVID-19 mortality; COVID-19 pandemic; COVID-19 vaccine; Centers for Disease Control and Prevention (U.S.); Clinical; Computerized Medical Record; Country; Data; Dementia; Diagnosis; Elderly; Geriatrics; Gerontology; Health Care Research; Healthcare; Healthcare Systems; Home Nursing Care; Immune system; Immunology; Impaired cognition; Incidence; Infection; Long-Term Care; Medical; Monitor; Morbidity - disease rate; Mortality Decline; Nursing Homes; Population; Provider; Quality of life; Reporting; Residential Treatment; Scheme; Social Interaction; Social isolation; Symptoms; System; Testing; Time; Universities; Update; Vaccines; Virus; Vulnerable Populations; adverse event monitoring; aged; base; collaboratory; data infrastructure; design; experience; phase III trial; recruit; response; social group; systems research

PROJECT SUMMARY The SARS-CoV-2 pandemic has had a devastating impact on the nursing home and residential care population in the US and beyond. Between 40% and 80% of all COVID-19 deaths have been among residents of nursing homes or assisted living facilities. Despite a declining mortality rate among those who have confirmed infection, the virus’ impact on nursing home residents’ functioning and quality of life remains significant due to both COVID-19’s medical sequelae and the social isolation arising from visitor restrictions, social interactions and group activity restrictions. As of September 2020, there are 4 vaccines in Phase 3 trials in the US. These trials aim to recruit over 30,000 thousand subjects each, but few will be frail, aged, or with multiple morbidities. However, frail older persons living in congregate settings are in the top priority group for distribution of the virus once approved. However, since there is considerable evidence that the immune system of frail older people is not as responsive as that of the younger population on which these vaccines are being tested, careful monitoring of their response to the vaccine will be required. Presently, the Centers for Disease Control (CDC) has limited ability to monitor for adverse events (AEs) of a SARS-COV-2 vaccine in the nursing home population. Since April, 2020, Brown University’s Center for Gerontology & Healthcare Research has been working the Genesis HealthCare, the largest provider of institutional long-term care in the country with some 400 facilities in 25 states. Genesis hosts its own electronic medical record (EMR) system and, working with Brown IT staff, has been transferring most of the data in its EMR to Brown nightly. We propose to use this extensive, detailed and timely data infrastructure to build a nursing home based AE monitoring system to monitor the incidence of a variety of different types of adverse effects experienced by nursing home residents. We propose to: 1. Design and build an updated system for identifying, flagging and highlighting within resident changes in clinical status; 2. convene a team of experts in clinical geriatrics and immunology to propose a multiplicity of diagnoses, functional, symptom or vital sign changes indicative of an adverse reaction to the administration of a vaccine; 3. develop such indicators specifically focused on the population of residents with dementia and/or significant cognitive impairment; and, 4. design and test a twice-weekly reporting scheme that could be put into practice as soon as Genesis facilities begin to receive the different types of vaccine.

项目摘要 SARS-CoV-2大流行对养老院和住宿护理人群造成了毁灭性的影响 在美国和其他地方。在所有COVID-19死亡病例中，40%至80%是护理人员 家庭或辅助生活设施。尽管在那些已经证实 感染，病毒对疗养院居民的功能和生活质量的影响仍然显着， 无论是COVID-19的医学后遗症，还是因游客限制、社交互动 和团体活动限制。截至2020年9月，有4种疫苗在美国进行3期试验。这些 每项试验的目标是招募超过30，000名受试者，但很少有人是体弱，年老或患有多种疾病。 然而，生活在聚集环境中的体弱老年人是病毒传播的最优先群体 一旦批准。然而，由于有大量证据表明体弱老年人的免疫系统受到损害， 这些疫苗的反应不如正在接受测试的年轻人群， 需要监测他们对疫苗的反应。目前，疾病控制中心（CDC） 在疗养院监测SARS-COV-2疫苗不良事件（AE）的能力有限 人口自2020年4月以来，布朗大学老年学和医疗保健研究中心一直在 在Genesis HealthCare工作，Genesis HealthCare是该国最大的机构长期护理提供商， 25个州的400个设施。Genesis拥有自己的电子病历（EMR）系统，并与 布朗的IT人员，一直在转移其EMR的大部分数据到布朗每晚。我们建议用这个 广泛、详细和及时的数据基础设施，以建立基于养老院的AE监测系统， 监测发生率的各种不同类型的不良反应所经历的养老院居民。 我们建议：1.设计和建立一个更新的系统，用于识别，标记和突出显示居民 临床状态的变化; 2.召集一个临床老年医学和免疫学专家小组， 多种诊断、功能、症状或生命体征变化提示对药物的不良反应 疫苗的施用; 3.制定此类指标，具体侧重于 痴呆和/或显著的认知障碍;以及，4.设计并测试每周两次的报告计划， 一旦创世公司的设施开始接受不同类型的疫苗，就可以付诸实践。