NIA AD/ADRD Health Care Systems Research Collaboratory

PROJECT SUMMARYThe SARS-CoV-2 pandemic has had a devastating impact on the nursing home and residential care populationin the US and beyond. Between 40% and 80% of all COVID-19 deaths have been among residents of nursinghomes or assisted living facilities. Despite a declining mortality rate among those who have confirmedinfection, the virus' impact on nursing home residents' functioning and quality of life remains significant due toboth COVID-19's medical sequelae and the social isolation arising from visitor restrictions, social interactionsand group activity restrictions. As of September 2020, there are 4 vaccines in Phase 3 trials in the US. Thesetrials 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 virusonce approved. However, since there is considerable evidence that the immune system of frail older people isnot as responsive as that of the younger population on which these vaccines are being tested, carefulmonitoring 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 homepopulation. Since April, 2020, Brown University's Center for Gerontology & Healthcare Research has beenworking the Genesis HealthCare, the largest provider of institutional long-term care in the country with some400 facilities in 25 states. Genesis hosts its own electronic medical record (EMR) system and, working withBrown IT staff, has been transferring most of the data in its EMR to Brown nightly. We propose to use thisextensive, detailed and timely data infrastructure to build a nursing home based AE monitoring system tomonitor 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 residentchanges in clinical status; 2. convene a team of experts in clinical geriatrics and immunology to propose amultiplicity of diagnoses, functional, symptom or vital sign changes indicative of an adverse reaction to theadministration of a vaccine; 3. develop such indicators specifically focused on the population of residents withdementia and/or significant cognitive impairment; and, 4. design and test a twice-weekly reporting scheme thatcould be put into practice as soon as Genesis facilities begin to receive the different types of vaccine.