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.
SARS-CoV-2 has devastated US nursing homes, killing a high proportion of this vulnerable population. Once a vaccine has been approved, current plans are to administer to all nursing home residents quickly. We propose building and testing a real time Adverse Events monitoring system using electronic medical records updated daily from a large national nursing home chain that will be able to serve as an early warning system of unanticipated adverse effects of receiving a SARS-CoV-2 vaccine.
