Infections like flu, urine infections, diarrhoea, and vomiting are prevalent in older adults in care homes and often cause severe illnesses requiring hospital treatment. They are vulnerable to severe infections such as COVID-19 and influenza. However, many infections and outbreaks could be prevented by controlling outbreak measures, such as care home closures to visitors and new admissions, which harm their quality of life. The first step is to measure them reliably. Still, it is challenging in care homes due to the lack of data and research. The COVID-19 pandemic highlighted why we need better evidence and new ways to protect people who live and work in care homes from infection.
VIVALDI Social Care conducts a study during the pandemic to collect data about COVID-19 infections in residents and staff by partnering with care providers. VIVALDI social care is a model that provides high-quality care services in the UK. It emphasises providing person-centred social care services using available resources. The VIVALDI study aims to establish robust surveillance and a research database that supports long-term improvements in social care health practices. The study includes staff, residents, relatives, care providers, and researchers.
Study Objects
The study from October 2023 to March 2025 includes 500-1500 care homes for older adults in England. The study has many objectives, including establishing a nationwide network of care homes for ongoing surveillance of infections, antimicrobial resistance, and disease outbreaks. It also includes:
- Collecting and linking resident health data from Digital Social Care Records (DSCR) with pseudonymisation datasets to enable comprehensive research and monitoring.
- Analysing infection patterns, hospitalisation, vaccination response, antibiotic use, and mortality among residents to inform future interventions.
- Assessing the feasibility of implementing a long-term infection control and monitoring system in care homes.
- Engaging prime stakeholders, such as healthcare professionals, care staff, residents, families, and policymakers, to develop ethical and practical guidelines for research and infection control in care homes.
- Providing evidence-based recommendations to inform national infection control policies and support the development of new healthcare frameworks for the social care sector.
- Enhancing digital healthcare integration within care homes to improve infection tracking and response strategies.
Study Design
In England, around 380,000 people live in 11,000 care homes for older adults, which is still increasing. Most care home residents are older than 85 years, and at least two-thirds live with dementia. The average life expectancy within the care home is 12 to 24 months. The COVID-19 pandemic has highlighted that care home residents are highly vulnerable to severe infection outbreaks. It includes skin infections, respiratory (e.g., influenza, pneumonia), antimicrobial resistance (AMR), gastrointestinal (e.g., norovirus), and urinary tract. The outbreaks can cause negative consequences like the closing down of care homes to visitors, new admissions, and preventable hospital admissions.
Many of these infections and outbreaks could be prevented by implementing effective interventions and generating new evidence on preventing or reducing infection where none currently exists. Inadequate research and data networks, the fragmentation of social care, poor integration of health and social care, multiple providers, and other services that impact health and well-being are complex barriers to reducing the impact of infection. This gap in care home-specific data and surveillance is filled by care home recruitment.
The study aims to recruit between 500 and 1,500 care homes across England, considering all sizes, locations, and resident population diversity. Care home providers are directly engaged through professional networks and healthcare organisations. Conferences, events, press releases, magazine articles, newsletters, webinars, and podcasts are conducted for care home managers and staff. It educated care home managers and staff about the benefits of participation.
The study collects data from multiple resources to provide a complete view of infection control and healthcare practices within care homes. They collect routine infection reports from care home medical staff to detect infections and resistant bacterial strains. It provides incidence rates of specific infectious diseases (e.g., respiratory infections, urinary tract infections, and stomach flu outbreaks). It also collects data about how many older adults get COVID-19, influenza, and pneumococcal vaccines. Its efficacy and side effects among older adults.
Hospital admissions related to sepsis, pneumonia, and other severe infection outcomes are also collected. It helps to determine infection-related mortality rates and long-term health outcomes for residents post-infection. The study also analyses antibiotic prescription patterns in care homes. It includes data about pre-existing health conditions and immune responses to vaccines and infections in care home residents.
Setting
Care Quality Commission (CQC) registered care homes that provide residential or nursing care for older people (aged >=65 years) in England and use DSCR. DSCR (Digital Social Care Record) identifies residents within participating care homes and links the data (infections, vaccinations, clinical outcomes, hospital admissions, and deaths) to national datasets.
Inclusion Criteria
Care homes in England provide residential or nursing care for older adults. Residents who have not opted out of data collection.
Exclusion Criteria
The residents who primarily provide care to residents of care homes <65 years. However, residents younger than 65 whoprimarily provide careand live in care homes will be eligible for inclusion.
Consent
A key feature of this study is to be inclusive. Its goal is for every care home resident to have the opportunity to participate. Hence, it is not biased, and the findings are relevant to all older adults in care homes. The database must be up-to-date, accurate, and complete for the study to detect the burden of infection and related outcomes. This is because infections spread between people. Short-stay residents often get excluded from research and studies based on routinely collected data. They are more likely to bring infections into care homes because they have recently been in the hospital.
It is estimated about 70% of care home residents live with cognitive impairment and may not be able to provide consent for participation in the study. Identifying consultees to support the consent process in those lacking capacity is possible. This is time-consuming and requires dedicated staff. It may cause extreme staff shortages and a lack of embedded research infrastructure in the care sector. So, it means it is not feasible for staff to seek consent from every care home resident.
The study soughtsupport from Section 251 of the Health Research Authority Confidentiality Advisory Group (HRA CAG). This law allows data collection from all residents without consent, with the option that residents may opt out of data sharing. In large care provider organisations, their senior management team will decide to participate. Then, home managers will be asked to confirm whether their care home is willing to participate. The decision to take part will be made by the care home manager in care homes that are not part of larger organisations.
Timelines
Study recruitment will be possible on appropriate ethical approvals and is anticipated to start in January 2024. Data collection will be initiated following the initial onboarding period (approximately two months). It will continue for a maximum of twelve months. The database will be completed, locked in March 2025, and securely stored for ten years. Data analysis will start during the study period or after data collection.
Outcomes
Primary outcomes
The primary outcome of this study is the establishment of sentinel surveillance and a research database that enables observational and future interventional studies on infection in older adult residents of care homes in England.
Secondary Outcomes
- Study design and delivery that has been co-produced with care home stakeholders. Descriptions and reflections on the process will be published and disseminated.
- A network of 500–1500 participating care homes has been established with appropriate contracts.
- Suitable data governance and ethical approvals are established.
- Effective data pipelines are created to collect individual-level data on care home residents and pseudonymisation. This routinely collected dataset is then linked to create a research database.
- An effective Data Access Committee is established, comprising key stakeholders that describe working methods implemented in future research.
- An effective data opt-out system for residents to opt out shows that data can be shared for future databases.
- Incidence of AMR (Antimicrobial resistance) and shaping of association with antimicrobial prescribing practice in care home residents can be determined.
Conclusions
This study builds on the care homes’ experience and lessons learned from the COVID-19 pandemic. It highlighted the urgent need for an effective data and research infrastructure that helps in surveillance, research on infections and outbreaks, and policy-making. This study also highlighted the issue which was pointed out by the Chief Medical Officer in his Technical Report on the COVID-19 pandemic. Sentinel surveillance will improve as the study helps to measure the overload of infection and AMR in care homes. The research database will be available to the researchers to help in future observational and modelling studies.
The database could also help in future interventional studies that depend on more ethical and governance approvals. The study will be conducted by a partnership of UCL, care sector organisations, care providers, digital suppliers and policymakers. Data use and project delivery will be managed by a stakeholder management group, including care home staff, providers, residents, and relatives. This project primarily focuses on infectious diseases and AMR. If it is successful, residents and their relatives will continue to support data sharing. This database could be repurposed and reused for other care sector-led research studies. It serves as a broader portfolio to addressing priorities such as falls or dementia.