Vivaldi Social Care

University College London (UCL), Care England and The Outstanding Society Community Interest Company (TOSCIC) require access to NHS England data for the purpose of the following research project:

Vivaldi Social Care

The following is a summary of the aims of the research project:

Before COVID-19 there was very little information on disease burden, health care utilisation and clinical outcomes in care home residents because there was no reliable method to identify residents in routine data, and no systems to collect data specifically for this population. During the pandemic, regular testing for COVID-19 in care homes staff and residents created a registry of the care home population (because test results shared with NHSE were labelled with individuals’ NHS numbers and their care home identifier). This information was linked to routine datasets within NHS Foundry in the VIVALDI study providing accurate and timely estimates of COVID-19 infections, related outcomes, immunity and vaccine effectiveness in care home residents and staff. This evidence was critical to the public health response to COVID-19. It also showed that it is feasible to rapidly generate research / surveillance in care homes to inform policy, by working in partnership with providers.

There is enormous scope to re-purpose this model to generate evidence on how to improve outcomes for care home residents and streamline interactions between the NHS and social care. A natural next step would be to address other leading causes of infection and outbreaks in care homes such as influenza or norovirus, which cause substantial morbidity and mortality, care home closures and drive NHS winter pressures every year. Now regular testing for COVID-19 has stopped this requires a new approach to generate a ‘care home registry’.

The aim of the study is to pilot a system of surveillance for infection and antimicrobial resistance in care homes for older adults, and to demonstrate its capacity to deliver as a trial infrastructure for public health research. UCL, Care England and TOSCIC will also demonstrate the steps that would be required to embed a long-term continuous study, with the goal to inform a permanent programme of care home research, surveillance and quality improvement.

Objectives:

1. To regularly ingest data (NHS numbers, care home identifier, calendar date) from residents in 500-1500 care homes into NHSE, in order to link this information to routine datasets (hospital admissions, vaccinations, deaths, laboratory results, prescriptions). These datasets are already held by NHSE, with the exception of laboratory test results (Second Generation Surveillance System, SGSS) which are held by the UKHSA.

2. To develop and produce outputs (reports, dashboards) for care providers, policymakers and the public which summarise the impact of priority infections in care homes to inform quality improvement and public health activities, research prioritisation, and improve health outcomes for care home residents, particularly in relation to infection control.

3. To establish a research database that researchers can use to deliver observational studies on infection and AMR, and to explore use of the platform to enable interventional research studies e.g. cluster randomised controlled trials (subject to additional approvals, not included as part of this DSA)

4. To explore use of the platform to deliver near real-time surveillance for priority infections e.g. influenza, norovirus, COVID-19

5. To build capacity in public health surveillance, QI and research in care homes

The following NHS England Data will be accessed:

> Hospital Episode Statistics Admitted Patient Care (HES APC) – necessary:

a. To measure rates of hospital admission for specific infections and infection syndromes (e.g. urinary tract infections, blood stream infections, respiratory infections). This information is not currently available for care home residents. It will support quality improvement and policy to reduce the burden and impact of infection in care home residents.

b. To measure overall rates of hospital admission in an accurate, well defined cohort of care home residents. This information will improve the understanding of the care home population and their interactions with the NHS – relevant to policymakers, care home residents and their families.

c. To use data on prior hospital admissions to infer levels of comorbidity in the care home population. This is essential when trying to make comparisons between care homes.

> Emergency Care Data Set (ECDS) – necessary:

a. To measure rates of A&E attendances for specific infections and infection syndromes (e.g. urinary tract infections, blood stream infections, respiratory infections). This information is not currently available for care home residents. It will support quality improvement and policy to reduce the burden and impact of infection in care home residents, particularly in relation to avoidable attendances at A&E and subsequent hospital admissions

b. To measure overall rates of A&E attendances in an accurate, well defined cohort of care home residents. This information will improve the understanding of the care home population and their interactions with the NHS – relevant to policymakers, care home residents and their families.

> Civil Registration Mortality – necessary:

a. To measure overall rates of death and causes of death in a well-defined cohort of care home residents. UCL currently lack accurate information on these outcomes because there is no national registry of who lives in a care home. This information is likely to be of relevance to policymakers, care home residents and their families.

b. To estimate the burden of infection-related death in care home residents – relevant to policymakers, care home residents and their families.

> Medicines dispensed in Primary Care (NHSBSA data) - necessary:

To estimate rates of antibiotic usage in care home residents, and how this varies between care homes. UCL currently lack reliable estimate of antibiotic usage in this population which undermines efforts to tackle the problem of antibiotic resistance in care home residents (residents have higher rates of AMR compared to the general population of comparable age). This information will help policymakers and providers understand which types of interventions are likely to have the biggest impact on antibiotic prescribing and AMR in specific care homes.

Antibiotic overuse drives antibiotic resistance. NHSBSA data is required to help address one of the key aims of the Government’s National AMR action plan which is to safely reduce and optimise antimicrobial use to reduce the risk of AMR, consequently reducing inappropriate and unnecessary exposure to antibiotics is a patient safety issue. The dataset established in this project is also to be used to investigate the effectiveness of different types, doses and durations and antibiotic therapy in care home residents.

The aim of data sharing with the UKHSA is to provide intelligence specifically for the purpose of quality improvement, public health activities such as monitoring infection trends, and research prioritisation in order to improve health outcomes for care home residents in relation to the prevention and management of infections.

UKHSA requires aggregated data without small number suppression because small numbers of events in any given care home in any given month will be common and the rounding of all reported data fields would mask trends and variation between care homes – substantially reducing the benefit provided by this project. All cause hospital admissions and mortality are common events within the care home setting, and reporting aggregate numbers back to care providers without any small number suppression will not present a risk of disclosure of confidential information that is not already held by the provider. ISB1523 guidelines will still be applied for aggregate data on specific medical conditions in order to provide usable monthly summaries for common conditions, whilst removing the risk of disclosure for rare conditions.

The level of the Data will be: Pseudonymised

The Data will be minimised as follows:

> Limited to a study cohort identified by Person Centred Software, Nourish, Camascope* – approximately 15,000 to 45,000 residents of 500-1500 care homes for older adults in England. Care homes in all regions are eligible to participate, provided they are using Digital Care records provided by one of the software suppliers that are partnering on the project (Person Centred Software, Nourish, Camascope).

> Limited to data between 2021 – latest available; 3-years of historic data is required as the average length of stay in a care home is around 2.5 years.

> A derivation of date of death will be supplied in Month/Year format

*These software vendors supply digital care records to participating care homes.

The lawful basis for processing personal data under the UK GDPR is:

For UCL, Care England and TOSCIC:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

For the dashboard summarising the care home population and the burden of infection in care home residents purpose:

Article 9(2)(i) - processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy.

For the research studies undertaken using the Vivaldi Social Care database purpose:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The funding comes from multiple sources. Current funders include:

> The UK Health Security Agency (UKHSA)

> National Institute for Health and Care Research (NIHR)

Funding to continue the work described will be sought on an ongoing basis.

The funders will have no ability to suppress or otherwise limit the publication of findings.

Quantaim Limited is a processor acting under the instructions of UCL. Quantaim Limited’s role is limited to curating and managing the Vivaldi Social care database in the UCL DSH.

Quantaim Limited are listed as a party in a data processor agreement between UCL (acting on behalf of the joint data controllers), NHSE and Quantaim Limited.

Amazon Web Services (AWS) provides IT hosting services to UCL and will store the Data as contracted by UCL. AWS’ role is limited to secure backup of data stored in UCL’s Data Safe Haven.

UCL uses offsite data centre services provided by VIRTUS data centre. VIRTUS does not have access to the data.

UKSHA is a processor acting under the instructions of UCL to generate Public Health Reports / dashboards. UKHSA will not have access to record level data under this Data Sharing Agreement, but will have access to aggregate data without small number suppression and are therefore listed as a data processor.

Data will be accessed by:

• Substantive employees of UCL and Quantaim Limited

• Individuals holding an honorary contract under the supervision of a substantive employee of UCL for the purposes described in this DSA only. UCL must maintain records in a single location that cover the following details of each individual given access under an honorary contract: o Their substantive employer;

o Their role in respect of the purpose for the processing specified in the DSA;

o The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

o The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA; o Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

Since its inception in May 2020, the Vivaldi Social Care study has evolved through collaboration with groups like TOSCIC and Rights for Residents to better understand the care sector and the complexities of using routinely collected data. The study aims to ensure residents, including those lacking capacity, can participate while providing clear opportunities to opt out. This opt-out model, developed in consultation with care home stakeholders, balances inclusivity with ethical data usage. Engagement efforts have included task groups, working groups, and dissemination events, culminating in a co-produced governance model involving UCL, Care England, and TOSCIC as joint data controllers.

The study has actively sought resident and relative input, holding targeted events and care home visits to refine materials and address concerns. Feedback has been overwhelmingly supportive, with residents recognising the study's importance in improving care quality, particularly in light of challenges faced during the COVID-19 pandemic. Rights for Residents plays a vital role, advocating for transparency, data protection, and resident representation. The project is overseen by the Adult Social Care Engagement Collective and remains committed to collaboration, aiming to share findings widely across the care sector. ASCEC, comprises 30-40 members of the public, care home relatives, care providers, care home staff and charities. UCL, Care England and TOSCIC will work with their ASCEC to find effective ways to share the research findings with the care sector. This builds on Vivaldi’s existing experience of working collaboratively with care home residents, relatives, staff and providers, which is explored on their website.

The expected outputs of the processing will be:

> Dashboard(s) for policymakers, and care home providers. These will summarise key features of the care home population and will include care home level data on the burden of infection and AMR in residents. This information is expected to help providers and policymakers at local, regional and national level understand variation in care outcomes (e.g. rates of antibiotic prescribing, rates of hospital admissions for urinary tract infections) to better target their quality improvement activities and evidence-based policymaking.

> Submissions to peer reviewed journals

> Presentations at appropriate Care Sector conferences

UKHSA Dashboard Development:

Intelligence is vital to improving how UCL prevent and manage infections in care homes because it helps care providers and policymakers to target interventions to where they are likely to have greatest impact, and ensures decisions are evidence-based. By gathering and analysing data on infection trends care providers and public health bodies can prioritise the infection threats that are most pertinent in their setting and thus deploy interventions that are most likely to be effective in protecting their residents.

Care Home Provider Dashboard:

UKHSA will produce a dashboard accessible to each care provider participating in VIVALDI Social Care to bring together key intelligence in a clear, accessible format. To ensure confidentiality and security, the system will use access-based controls, meaning that each provider will only be able to view and manage their own data. For single-site providers, this means they will only see and manage their own data on infections. For providers that are part of larger groups, dashboards will be structured to allow oversight at the corporate level. This enables a designated person to share information with their care home managers to monitor local trends, while the corporate body has a consolidated view across all sites, helping identify wider trends, compare performance, and coordinate support where needed. Access rights will be managed by the designated person so that frontline staff, site managers, and corporate leadership each see the level of information relevant to their responsibilities, ensuring that intelligence is actionable at every level without compromising data protection.

The dashboard outputs will be suppressed in line with ISB1523 guidelines for data relating to specific medical conditions. The dashboard outputs will not be suppressed for all-cause hospital admissions or mortality data. The dashboard will have analytical and downloadable data functions.

Policymaker Dashboard:

Regulators or oversight bodies, such as DHSC and NHSE will have more restricted, role-appropriate access to aggregated or comparative reports from the dashboard. They and UKHSA may use the data for policy purposes and in managing public health risks in relation to infection control. UKHSA and UCL will require full access to support the dashboard build, for quality assurance purposes to ensure the data is accurate and consistent with source data, and to compare it to other data sources for consistency. Individuals will be given different access rights to ensure those with full access have a suitable business need.

The policymaker dashboard interface will have all outputs suppressed in line with ISB1523, and will not include directly identifying information alongside the data for individual care homes.

The outputs will only contain aggregated information with small numbers suppressed as appropriate in line with the respective disclosure rules.

The outputs will be communicated to relevant recipients through the following dissemination channels:

> Journals

> Conferences

> Podcasts

> Short videos; aimed at care home staff, care providers, relatives/ family members of residents and residents (recognising that many residents have cognitive impairment so UCL will also need simpler outputs to convey findings to this group). These videos will be shared via social media (e.g. LinkedIn, Facebook, twitter), they study website, at conferences, trade shows, care sector meetings, and meetings with policymakers.

The aim is to begin setting up the study dashboards in mid-2025. Research outputs (publications, policy briefings, conference presentations) are then expected to be made available from January 2026 onwards.

Multi-media outputs will be produced throughout this period (newsletters, podcasts, press releases, conference presentations and updates on the project, care home visits, video(s)). Engagement activities and dissemination plans are overseen by the Adult Social Care Engagement Collective – a group of relatives, care home staff, providers, members of the public and people representing charities.

The first data from one care home began to flow in January 2025, however the majority of care homes began submitting data in July 2025. Therefore UCL have not yet accrued sufficient data to provide outputs back to policymakers or care providers.

The first report for care home providers will be shared in November 2025. It includes summary information on the main reasons why antibiotics are being prescribed to residents, and information on variation in rates of hospital admission in residents by month. The dashboards (requiring this Amendment to the Data Sharing Agreement) will enable set up of dashboards to return care home level information to care providers and policymakers. UCL anticipate the first research outputs from this study in January 2026 once UCL have accrued 6 months follow-up data from participating care homes.

University College London (UCL), Care England and The Outstanding Society Community Interest Company (TOSCIC) require access to NHS England data for the purpose of the following research project:

Vivaldi Social Care

The following is a summary of the aims of the research project:

Before COVID-19 there was very little information on disease burden, health care utilisation and clinical outcomes in care home residents because there was no reliable method to identify residents in routine data, and no systems to collect data specifically for this population. During the pandemic, regular testing for COVID-19 in care homes staff and residents created a registry of the care home population (because test results shared with NHSE were labelled with individuals’ NHS numbers and their care home identifier). This information was linked to routine datasets within NHS Foundry in the VIVALDI study providing accurate and timely estimates of COVID-19 infections, related outcomes, immunity and vaccine effectiveness in care home residents and staff. This evidence was critical to the public health response to COVID-19. It also showed that it is feasible to rapidly generate research / surveillance in care homes to inform policy, by working in partnership with providers.

There is enormous scope to re-purpose this model to generate evidence on how to improve outcomes for care home residents and streamline interactions between the NHS and social care. A natural next step would be to address other leading causes of infection and outbreaks in care homes such as influenza or norovirus, which cause substantial morbidity and mortality, care home closures and drive NHS winter pressures every year. Now regular testing for COVID-19 has stopped this requires a new approach to generate a ‘care home registry’.

The aim of the study is to pilot a system of surveillance for infection and antimicrobial resistance in care homes for older adults, and to demonstrate its capacity to deliver as a trial infrastructure for public health research. UCL, Care England and TOSCIC will also demonstrate the steps that would be required to embed a long-term continuous study, with the goal to inform a permanent programme of care home research, surveillance and quality improvement.

Objectives:

1. To regularly ingest data (NHS numbers, care home identifier, calendar date) from residents in 500-1500 care homes into NHSE, in order to link this information to routine datasets (hospital admissions, vaccinations, deaths, laboratory results, prescriptions). These datasets are already held by NHSE, with the exception of laboratory test results (Second Generation Surveillance System, SGSS) which are held by the UKHSA. We are exploring whether it is possible for an extract of SGSS to be shared with NHSE for use in this project but this is not critical to project delivery.

2. To develop and produce outputs (reports, dashboards) for care providers, policymakers and the public which summarise the impact of priority infections in care homes to inform quality improvement and public health activities, and research prioritisation

3. To establish a research database that researchers can use to deliver observational studies on infection and AMR, and to explore use of the platform to enable interventional research studies e.g. cluster randomised controlled trials (subject to additional approvals, not included as part of this DSA)

4. To explore use of the platform to deliver near real-time surveillance for priority infections e.g. influenza, norovirus, COVID-19

5. To build capacity in public health surveillance, QI and research in care homes

The following NHS England Data will be accessed:

> Hospital Episode Statistics Admitted Patient Care (HES APC) – necessary:

a. To measure rates of hospital admission for specific infections and infection syndromes (e.g. urinary tract infections, blood stream infections, respiratory infections). This information is not currently available for care home residents. It will support quality improvement and policy to reduce the burden and impact of infection in care home residents.

b. To measure overall rates of hospital admission in an accurate, well defined cohort of care home residents. This information will improve our understanding of the care home population and their interactions with the NHS – relevant to policymakers, care home residents and their families.

c. To use data on prior hospital admissions to infer levels of comorbidity in the care home population. This is essential when trying to make comparisons between care homes.

> Emergency Care Data Set (ECDS) – necessary:

a. To measure rates of A&E attendances for specific infections and infection syndromes (e.g. urinary tract infections, blood stream infections, respiratory infections). This information is not currently available for care home residents. It will support quality improvement and policy to reduce the burden and impact of infection in care home residents, particularly in relation to avoidable attendances at A&E and subsequent hospital admissions

b. To measure overall rates of A&E attendances in an accurate, well defined cohort of care home residents. This information will improve our understanding of the care home population and their interactions with the NHS – relevant to policymakers, care home residents and their families.

> Civil Registration Mortality – necessary:

a. To measure overall rates of death and causes of death in a well-defined cohort of care home residents. We currently lack accurate information on these outcomes because there is no national registry of who lives in a care home. This information is likely to be of relevance to policymakers, care home residents and their families.

b. To estimate the burden of infection-related death in care home residents – relevant to policymakers, care home residents and their families.

> Medicines dispensed in Primary Care (NHSBSA data) - necessary:

To estimate rates of antibiotic usage in care home residents, and how this varies between care homes. We currently lack reliable estimate of antibiotic usage in this population which undermines efforts to tackle the problem of antibiotic resistance in care home residents (residents have higher rates of AMR compared to the general population of comparable age). This information will help policymakers and providers understand which types of interventions are likely to have the biggest impact on antibiotic prescribing and AMR in specific care homes.

Antibiotic overuse drives antibiotic resistance. NHSBSA data is requested to help address one of the key aims of the Government’s National AMR action plan which is to safely reduce and optimise antimicrobial use to reduce the risk of AMR, consequently reducing inappropriate and unnecessary exposure to antibiotics is a patient safety issue. The dataset established in this project is also to be used to investigate the effectiveness of different types, doses and durations and antibiotic therapy in care home residents.

The level of the Data will be:

> Pseudonymised

The Data will be minimised as follows:

> Limited to a study cohort identified by Person Centred Software, Nourish, Camascope* – approximately 15,000-45,000 residents of 500-1500 care homes for older adults in England. Care homes in all regions are eligible to participate, provided they are using Digital Care records provided by one of the software suppliers that are partnering on the project (Person Centred Software, Nourish, Camascope).

> Limited to data between 2021 – latest available; 3-years of historic data is required as the average length of stay in a care home is around 2.5 years.

> A derivation of date of death will be supplied in Month/Year format

*These software vendors supply digital care records to participating care homes.

The lawful basis for processing personal data under the UK GDPR is:

For UCL, Care England and TOSCIC:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

For the dashboard summarising the care home population and the burden of infection in care home residents purpose:

Article 9(2)(i) - processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy.

For the research studies undertaken using the Vivaldi Social Care database purpose:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The funding comes from multiple sources. Current funders include:

> The UK Health Security Agency (UKHSA)

> National Institute for Health and Care Research (NIHR)

Funding to continue the work described will be sought on an ongoing basis.

The funders will have no ability to suppress or otherwise limit the publication of findings.

Quantaim Limited is a processor acting under the instructions of UCL. Quantaim Limited’s role is limited to curating and managing the Vivaldi Social care database in the UCL DSH.

Quantaim Limited are listed as a party in a data processor agreement between UCL (acting on behalf of the joint data controllers), NHSE and Quantaim Limited.

Amazon Web Services (AWS) provides IT hosting services to UCL and will store the Data as contracted by UCL. AWS’ role is limited to secure backup of data stored in UCL’s Data Safe Haven.

UCL uses offsite data centre services provided by VIRTUS data centre. VIRTUS does not have access to the data.

Data will be accessed by:

• Substantive employees of UCL and Quantaim Limited

• Individuals holding an honorary contract under the supervision of a substantive employee of UCL for the purposes described in this DSA only. UCL must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

o Their substantive employer;

o Their role in respect of the purpose for the processing specified in the DSA;

o The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

o The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA;

o Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

Since its inception in May 2020, the Vivaldi Social Care study has evolved through collaboration with groups like TOSCIC and Rights for Residents to better understand the care sector and the complexities of using routinely collected data. The study aims to ensure residents, including those lacking capacity, can participate while providing clear opportunities to opt out. This opt-out model, developed in consultation with care home stakeholders, balances inclusivity with ethical data usage. Engagement efforts have included task groups, working groups, and dissemination events, culminating in a co-produced governance model involving UCL, Care England, and TOSCIC as joint data controllers.

The study has actively sought resident and relative input, holding targeted events and care home visits to refine materials and address concerns. Feedback has been overwhelmingly supportive, with residents recognising the study's importance in improving care quality, particularly in light of challenges faced during the COVID-19 pandemic. Rights for Residents plays a vital role, advocating for transparency, data protection, and resident representation. The project is overseen by the Adult Social Care Engagement Collective and remains committed to collaboration, aiming to share findings widely across the care sector. ASCEC, comprises 30-40 members of the public, care home relatives, care providers, care home staff and charities. UCL, Care England and TOSCIC will work with their ASCEC to find effective ways to share the research findings with the care sector. This builds on Vivaldi’s existing experience of working collaboratively with care home residents, relatives, staff and providers, which is explored on their website.

The expected outputs of the processing will be:

> Dashboard(s) for policymakers, care home providers and the public. These will summarise key features of the care home population and will include care home level data on the burden of infection and AMR in residents. This information help providers and policymakers at local, regional and national level understand variation in care outcomes (e.g. rates of antibiotic prescribing, rates of hospital admissions for urinary tract infections) to better target their quality improvement activities and evidence-based policymaking.

> Submissions to peer reviewed journals

> Presentations at appropriate Care Sector conferences

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will not result in the re-identification of individual care homes.

The outputs will be communicated to relevant recipients through the following dissemination channels:

> Journals

> Conferences

> Podcasts

> Short videos; aimed at care home staff, care providers, relatives/ family members of residents and residents (recognising that many residents have cognitive impairment so we will also need simpler outputs to convey findings to this group). These videos will be shared via social media (e.g. LinkedIn, Facebook, twitter), they study website, at conferences, trade shows, care sector meetings, and meetings with policymakers.

The aim is to begin setting up the study dashboards in mid-2025. Research outputs (publications, policy briefings, conference presentations) are then expected to be made available from January 2026 onwards.

Multi-media outputs will be produced throughout this period (newsletters, podcasts, press releases, conference presentations and updates on the project, care home visits, video(s)). Engagement activities and dissemination plans are overseen by the Adult Social Care Engagement Collective – a group of relatives, care home staff, providers, members of the public and people representing charities.

University College London (UCL), Care England and The Outstanding Society Community Interest Company (TOSCIC) requires access to NHS England data for the purpose of the following research project:

Vivaldi Social Care

The following is a summary of the aims of the research project provided by UCL, Care England and TOSCIC:

Before COVID-19 there was very little information on disease burden, health care utilisation and clinical outcomes in care home residents because there was no reliable method to identify residents in routine data, and no systems to collect data specifically for this population. During the pandemic, regular testing for COVID-19 in care homes staff and residents created a registry of the care home population (because test results shared with NHSE were labelled with individuals’ NHS numbers and their care home identifier). This information was linked to routine datasets within NHS Foundry in the VIVALDI study providing accurate and timely estimates of COVID-19 infections, related outcomes, immunity and vaccine effectiveness in care home residents and staff. This evidence was critical to the public health response to COVID-19. It also showed that it is feasible to rapidly generate research / surveillance in care homes to inform policy, by working in partnership with providers.

There is enormous scope to re-purpose this model to generate evidence on how to improve outcomes for care home residents and streamline interactions between the NHS and social care. A natural next step would be to address other leading causes of infection and outbreaks in care homes such as influenza or norovirus, which cause substantial morbidity and mortality, care home closures and drive NHS winter pressures every year. Now regular testing for COVID-19 has stopped this requires a new approach to generate a ‘care home registry’.

The aim of the study is to pilot a system of surveillance for infection and antimicrobial resistance in care homes for older adults, and to demonstrate its capacity to deliver as a trial infrastructure for public health research. UCL, Care England and TOSCIC will also demonstrate the steps that would be required to embed a long-term continuous study, with the goal to inform a permanent programme of care home research, surveillance and quality improvement.

Objectives:

1. To regularly ingest data (NHS numbers, care home identifier, calendar date) from residents in 500-1500 care homes into NHSE, in order to link this information to routine datasets (hospital admissions, vaccinations, deaths, laboratory results, prescriptions). These datasets are already held by NHSE, with the exception of laboratory test results (Second Generation Surveillance System, SGSS) which are held by the UKHSA. We are exploring whether it is possible for an extract of SGSS to be shared with NHSE for use in this project but this is not critical to project delivery.

2. To develop and produce outputs (reports, dashboards) for care providers, policymakers and the public which summarise the impact of priority infections in care homes to inform quality improvement and public health activities, and research prioritisation

3. To establish a research database that researchers can use to deliver observational studies on infection and AMR, and to explore use of the platform to enable interventional research studies e.g. cluster randomised controlled trials (subject to additional approvals, not included as part of this DSA)

4. To explore use of the platform to deliver near real-time surveillance for priority infections e.g. influenza, norovirus, COVID-19

5. To build capacity in public health surveillance, QI and research in care homes

The following NHS England Data will be accessed:

> Hospital Episode Statistics Admitted Patient Care (HES APC) – necessary:

a. To measure rates of hospital admission for specific infections and infection syndromes (e.g. urinary tract infections, blood stream infections, respiratory infections). This information is not currently available for care home residents. It will support quality improvement and policy to reduce the burden and impact of infection in care home residents.

b. To measure overall rates of hospital admission in an accurate, well defined cohort of care home residents. This information will improve our understanding of the care home population and their interactions with the NHS – relevant to policymakers, care home residents and their families.

c. To use data on prior hospital admissions to infer levels of comorbidity in the care home population. This is essential when trying to make comparisons between care homes.

> Emergency Care Data Set (ECDS) – necessary:

a. To measure rates of A&E attendances for specific infections and infection syndromes (e.g. urinary tract infections, blood stream infections, respiratory infections). This information is not currently available for care home residents. It will support quality improvement and policy to reduce the burden and impact of infection in care home residents, particularly in relation to avoidable attendances at A&E and subsequent hospital admissions

b. To measure overall rates of A&E attendances in an accurate, well defined cohort of care home residents. This information will improve our understanding of the care home population and their interactions with the NHS – relevant to policymakers, care home residents and their families.

> Civil Registration Mortality – necessary:

a. To measure overall rates of death and causes of death in a well-defined cohort of care home residents. We currently lack accurate information on these outcomes because there is no national registry of who lives in a care home. This information is likely to be of relevance to policymakers, care home residents and their families.

b. To estimate the burden of infection-related death in care home residents – relevant to policymakers, care home residents and their families.

> Medicines dispensed in Primary Care (NHSBSA data) - necessary:

To estimate rates of antibiotic usage in care home residents, and how this varies between care homes. We currently lack reliable estimate of antibiotic usage in this population which undermines efforts to tackle the problem of antibiotic resistance in care home residents (residents have higher rates of AMR compared to the general population of comparable age). This information will help policymakers and providers understand which types of interventions are likely to have the biggest impact on antibiotic prescribing and AMR in specific care homes.

Antibiotic overuse drives antibiotic resistance. NHSBSA data is requested to help address one of the key aims of the Government’s National AMR action plan which is to safely reduce and optimise antimicrobial use to reduce the risk of AMR, consequently reducing inappropriate and unnecessary exposure to antibiotics is a patient safety issue. The dataset established in this project is also to be used to investigate the effectiveness of different types, doses and durations and antibiotic therapy in care home residents.

The level of the Data will be:

> Pseudonymised

The Data will be minimised as follows:

> Limited to a study cohort identified by Person Centred Software, Nourish, Camascope* – approximately 15,000-45,000 residents of 500-1500 care homes for older adults in England. Care homes in all regions are eligible to participate, provided they are using Digital Care records provided by one of the software suppliers that are partnering on the project (Person Centred Software, Nourish, Camascope).

> Limited to data between 2021 – latest available; 3-years of historic data is required as the average length of stay in a care home is around 2.5 years.

> A derivation of date of death will be supplied in Month/Year format

*These software vendors supply digital care records to participating care homes.

The lawful basis for processing personal data under the UK GDPR is:

For UCL, Care England and TOSCIC:

Article 6(1)(e) - processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller;

The lawful basis for processing special category data under the UK GDPR is:

For the dashboard summarising the care home population and the burden of infection in care home residents purpose:

Article 9(2)(i) - processing is necessary for reasons of public interest in the area of public health, such as protecting against serious cross-border threats to health or ensuring high standards of quality and safety of health care and of medicinal products or medical devices, on the basis of Union or Member State law which provides for suitable and specific measures to safeguard the rights and freedoms of the data subject, in particular professional secrecy.

For the research studies undertaken using the Vivaldi Social Care database purpose:

Article 9(2)(j) - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes in accordance with Article 89(1) based on Union or Member State law which shall be proportionate to the aim pursued, respect the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and the interests of the data subject.

The funding comes from multiple sources. Current funders include:

> The UK Health Security Agency (UKHSA)

> National Institute for Health and Care Research (NIHR)

Funding to continue the work described will be sought on an ongoing basis.

The funders will have no ability to suppress or otherwise limit the publication of findings.

Quantaim Limited is a processor acting under the instructions of UCL. Quantaim Limited’s role is limited to curating and managing the Vivaldi Social care database in the UCL DSH.

Quantaim Limited are listed as a party in a data processor agreement between UCL (acting on behalf of the joint data controllers), NHSE and Quantaim Limited.

Amazon Web Services (AWS) provides IT hosting services to UCL and will store the Data as contracted by UCL. AWS’ role is limited to secure backup of data stored in UCL’s Data Safe Haven.

UCL uses offsite data centre services provided by VIRTUS data centre. VIRTUS does not have access to the data.

Data will be accessed by:

• Substantive employees of UCL and Quantaim Limited

• Individuals holding an honorary contract under the supervision of a substantive employee of UCL for the purposes described in this DSA only. UCL must maintain records in a single location that cover the following details of each individual given access under an honorary contract:

o Their substantive employer;

o Their role in respect of the purpose for the processing specified in the DSA;

o The start date and end date of the duration in which the Data will be accessed by the individual under an honorary contract;

o The necessity for the Data to be accessed by the person(s) holding an honorary contract, instead of a substantive employee of an organisation named as controller or a processor in this DSA;

o Confirmation that an appropriate contract is in place which follows the relevant guidance and is countersigned by the substantive employer of the honorary contract holder.

Since its inception in May 2020, the Vivaldi Social Care study has evolved through collaboration with groups like TOSCIC and Rights for Residents to better understand the care sector and the complexities of using routinely collected data. The study aims to ensure residents, including those lacking capacity, can participate while providing clear opportunities to opt out. This opt-out model, developed in consultation with care home stakeholders, balances inclusivity with ethical data usage. Engagement efforts have included task groups, working groups, and dissemination events, culminating in a co-produced governance model involving UCL, Care England, and TOSCIC as joint data controllers.

The study has actively sought resident and relative input, holding targeted events and care home visits to refine materials and address concerns. Feedback has been overwhelmingly supportive, with residents recognising the study's importance in improving care quality, particularly in light of challenges faced during the COVID-19 pandemic. Rights for Residents plays a vital role, advocating for transparency, data protection, and resident representation. The project is overseen by the Adult Social Care Engagement Collective and remains committed to collaboration, aiming to share findings widely across the care sector. ASCEC, comprises 30-40 members of the public, care home relatives, care providers, care home staff and charities. UCL, Care England and TOSCIC will work with their ASCEC to find effective ways to share the research findings with the care sector. This builds on Vivaldi’s existing experience of working collaboratively with care home residents, relatives, staff and providers, which is explored on their website.

The expected outputs of the processing will be:

> Dashboard(s) for policymakers, care home providers and the public. These will summarise key features of the care home population and will include care home level data on the burden of infection and AMR in residents. This information help providers and policymakers at local, regional and national level understand variation in care outcomes (e.g. rates of antibiotic prescribing, rates of hospital admissions for urinary tract infections) to better target their quality improvement activities and evidence-based policymaking.

> Submissions to peer reviewed journals

> Presentations at appropriate Care Sector conferences

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will not result in the re-identification of individual care homes.

The outputs will be communicated to relevant recipients through the following dissemination channels:

> Journals

> Conferences

> Podcasts

> Short videos; aimed at care home staff, care providers, relatives/ family members of residents and residents (recognising that many residents have cognitive impairment so we will also need simpler outputs to convey findings to this group). These videos will be shared via social media (e.g. LinkedIn, Facebook, twitter), they study website, at conferences, trade shows, care sector meetings, and meetings with policymakers.

The aim is to begin setting up the study dashboards in mid-2025. Research outputs (publications, policy briefings, conference presentations) are then expected to be made available from January 2026 onwards.

Multi-media outputs will be produced throughout this period (newsletters, podcasts, press releases, conference presentations and updates on the project, care home visits, video(s)). Engagement activities and dissemination plans are overseen by the Adult Social Care Engagement Collective – a group of relatives, care home staff, providers, members of the public and people representing charities.

Yielded Benefits is not a requirement for new applications.