Protocol for VIVALDI social care: Pilot study to reduce infections, outbreaks and antimicrobial resistance in care homes for older adults.

ABSTRACT

Care home residents are vulnerable to severe outcomes from infections such as COVID-19 and influenza. However, measures to control outbreaks, such as care home closures to visitors and new admissions, have a detrimental impact on their quality of life. Many infections and outbreaks could be prevented but the first step is to measure them reliably. This is challenging in care homes due to the lack of data and research infrastructure. During the pandemic, the VIVALDI study measured COVID-19 infections in residents and staff by partnering with care providers and using routinely collected data. This study aims to establish sentinel surveillance and a research database to enable observational and future interventional studies in care homes. The project has been co-produced with care providers, staff, residents, relatives, and researchers. The study (October 2023 to March 2025) will explore the feasibility of establishing a network of 500-1500 care homes for older adults in England that is underpinned by a linked data platform. No data will be collected from staff. The cohort will be created by regularly extracting resident identifiers from Digital Social Care Records (DSCR), followed by pseudonymisation and linkage to routinely collected datasets. Following extensive consultation, we decided not to seek informed consent from residents for data collection, but they can 'opt out' of the study. Our goal is to be inclusive, and it is challenging to give every resident the opportunity to 'opt in' due to cognitive impairment and the requirement for consultees. The project, and all requests to use the data will be overseen by relatives, residents, staff, and care providers. The study has been approved by the Health Research Authority Confidentiality Advisory Group (23/CAG/0134&0135) and the South-West Frenchay Research Ethics Committee (23/SW/0105). It is funded by the UK Health Security Agency.

Infections like flu or COVID-19 are common in care homes and infected residents can become seriously unwell. When infections spread, the measures that are often used to stop outbreaks, like care home closures to visitors and new admissions, can have a detrimental impact on residents. The first step to solving this problem is being able to measure how often infections and outbreaks happen, and how this varies across care homes. This is currently difficult because there are no systems to collect data from care home residents. During the COVID-19 pandemic, care homes worked with researchers and Government to deliver a research study called VIVALDI which measured COVID-19 infections in residents and staff and monitored what happened to them. This pilot study builds on what we learned in the pandemic and aims to reduce the impact of common infections on residents. We will set up a network of 500-1500 care homes for older adults in England that are interested in research. By collecting limited data (NHS numbers) from residents in these homes and linking to other datasets already held in the secure NHS environment, we can measure the extent of infections in residents. We are not collecting data from staff, and any residents in the datasets cannot be identified. We will also create an anonymous database (names, dates of birth, NHS numbers removed), which researchers can use to find new ways to prevent infection in care homes. This will be stored securely by the research team. If the project is successful, and residents and relatives support it, we hope this approach can be used permanently to monitor infections in care homes. The study has been designed in partnership with care providers, experienced care staff, policymakers, academics, and residents and their relatives, who will also oversee the study and all research outputs.