Protocol for VIVALDI Social Care: Pilot Study to reduce Infections, Outbreaks and Antimicrobial Resistance in Care Homes for Older Adults

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 provisionally approved by the Health Research Authority Confidentiality Advisory Group and the South-West Frenchay Research Ethics Committee. It is funded by the UK Health Security Agency. ### Competing Interest Statement LS, AC, AH, OS, and KT report grants from the Department of Health & Social Care and the UK Health Security Agency (UKHSA) during the conduct of the study and LS was a member of the Social Care Working Group, which reported to the Scientific Advisory Group for Emergencies. GP, GC, and JH are employed by UKHSA who funded the study. AH reports funding from the COVID Core Studies Programme and was previously a member of the New and Emerging Respiratory Virus Threats Advisory Group at the Department of Health and Environmental Modelling Group of the Scientific Advisory Group for Emergencies. All other authors declare no competing interest. ### Funding Statement This work was supported by the National Institute for Health and Social Care Research Research Professorship (grant number 302435 to LS); the Wellcome Trust (grant number 222907/Z/21/Z to MK); Department of Health & Social Care (OS, AC, LS, KT); UK Health Data Research [grant number LOND1 to AH]; LS is funded by the NIHR University College London Hospitals Biomedical Research Centre. This work is independent research funded by the UK Health Security Agency. Views expressed in this publication are those of the authors and not necessarily those of the NHS, UKHSA or the Department of Health and Social Care. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes Data will be made accessible to researchers following approval of their project plan by the studys Data Access Committee and confirmation that they have completed appropriate information governance training.