DETERMIND: DETERMinants of quality of life, care and costs, and consequences of INequalities in people with Dementia and their family carers. NHS Digital data-linkage (mortality data) request.

Mortality data is required from NHS Digital for the purposes of the DETERMIND study.

The DETERMIND (DETERMinants of quality of life, care and costs, and consequences of INequalities in people with Dementia and their family carers) study is a multi-centre research study funded by the Economic and Social Research Council (ESRC), led by the University of Sussex, who are the Data Controller. It will gather new data, longitudinally, from a cohort of 900 people with a recent diagnosis of dementia and their carers (total = 1800). The objective is to provide a range of quantitative and qualitative evidence, interpreted using a theory of change framework, about inequalities in experiences, outcomes and costs following a diagnosis of dementia. . The study includes 7 separate workstreams.

Workstream 1 covers the recruitment of, and fieldwork with, the cohort of 1800 comprising people with dementia and their carers and Workstream 7 covers the development of the theory of change framework, an inductive process drawing upon emerging evidence from all of the workstreams, to provide an overall ‘theory of change model’ mapping the causal chains between service inputs and outcomes of interest - and identifying the contextual factors that influence the pathways people take and the outcomes they achieve.

Workstream 2 considers access to services and the factors that may influence inequalities in service access.

Workstream 3 looks at service and other costs associated with different patterns of service access and with different levels of outcome.

Workstream 4 looks at the experiences, costs and outcomes of self-funders relative to other care users.

Workstream 5 considers the role of psychological factors on differential service access and/or outcomes.

Workstream 6 looks at how the timing of diagnosis impacts outcomes. The DETERMIND dataset will include many measures in order to identify factors associated with variation in access , costs and outcomes, using evolving theories about how factors may be linked - informed by complementary qualitative research, consultation with stakeholders and existing evidence - to develop a theory of change that is plausible and consistent with the evidence gathered during the study.

The project runs for 5 years from January 2019 to December 2023.

The requested mortality data is to support the conduct of research undertaken as part of the DETERMIND study. Mortality data obtained from NHS Digital will be used to support and augment the gathering of data from a cohort of 900 people with a recent diagnosis of dementia and their carers (total 1800 people). Specifically, it will be used for the following purposes:

a. to include fact of death, place of death and cause of death in pseudonymised individual-level research (survey) data-sets generated by the research project, thus allowing these variables to be systematically included in statistical analyses

b. to formally withdraw study participants and their carers from the research study in a managed and timely manner (the expectation is that approximately 10% of those with a diagnosis of dementia in the cohort will die each year, approx. n=90 per annum). As well as supporting effective project management, this is designed to avoid inappropriately including the deceased participant and bereaved carer for participation in further survey rounds, or approaching them to invite them to participate in associated qualitative research or linked studies.

c. to prompt administration of a carer bereavement survey to members of the cohort who have given their consent to be contacted about involvement in further research.

The University of Sussex is a public authority responsible for conducting scientific research for academic and public benefit. Data in the DETERMIND study is processed to enable the University of Sussex to perform its public task. University of Sussex rely on the following legal bases for processing data under the General Data Protection Regulation

• GDPR Article 6 (1) (e), public task and, for special categories of data (including health information and information concerning ethnicity and sexual orientation), Article 9.2(j), archiving, research and statistics.

Possible ethical issues have been considered and addressed throughout the process, including those considered by the HRA REC approval process.”

Eligibility and procedures for recruitment of the cohort includes anyone with a recent diagnosis of dementia in three participating NHS Foundation Trusts - (Gateshead Health NHS Foundation Trust, South London and Maudsley (SLAM) NHS Foundation Trust and Sussex Partnership NHS Foundation Trust) with no exclusion criteria. The cohort also includes their listed carers. There are no control groups, as the study has a non-experimental design.

University of Sussex request mortality data for the study cohort of 900 people with a recent diagnosis of dementia and their carers, (total 1800) covering fact of death, alongside information about place and cause of death.

The data requested is proportionate to the purposes set out above and there are no alternative, less intrusive ways of achieving these purposes. The extent and level of data will allow individual cohort members to be appropriately withdrawn and approached about involvement in further research studies (as relevant), and to allow fact of death, place of death and cause of death to be included in multi-variate analyses of pseudonymised individual-level survey data gathered from the cohort.

As a multi-centre study, the project team includes a range of research partners in addition to the University of Sussex (the Data Controller). All of these research partners are co-applicants on the research grant (not sub-contractors) and their roles and responsibilities are consequently governed by DETERMIND’s governance framework (including the study protocol and ethical approvals). The majority of these research partners are data processors (i.e. for primary data gathered in the course of the study for the 900 people with a recent diagnosis of dementia and their carers (total 1800)). The roles and responsibilities of research partners (and co-applicants to the research grant), and their involvement in processing mortality data obtained from NHS Digital, are as follows.

South London and Maudsley (SLAM) NHS Foundation Trust; Gateshead Health NHS Foundation Trust; Sussex Partnership NHS Foundation Trust (SPFT)

Local Principal Investigators and Research Assistants in three local NHS memory assessment services (located within NHS Foundation Trusts) will work, on behalf of the University of Sussex and the project as a whole, to recruit the cohort of 900 people with a recent diagnosis of dementia (300 in each NHS Foundation Trust) and their carers (1800 in total) and will administer a face to face survey (at baseline assessment and annually for a further three years) to members of the cohort.

The Local Principal Investigators are clinical consultants within the NHS Foundation Trusts and are co-applicants on the research grant, thus included within the governance framework for the project (e.g. protocol and ethical approvals). To facilitate the involvement of the NHS Trusts in research, each Local Principal Investigator holds an academic affiliation in addition to their clinical roles within the NHS Trusts; the Local Principal Investigator at SPFT has an affiliation with the University of Sussex, the Local Principal Investigator at SLAM has an academic affiliation at King’s College London (KCL) and the Local Principal Investigator at Gateshead Health NHS Foundation Trust has an academic affiliation at Newcastle University. The roles of the three NHS Foundation Trusts are described fully in the study protocol. There are, additionally, associated capacity and capability agreements/ statement of activities in place for the participating NHS organisations.

The University of Sussex, the London School of Economics and Political Science (LSE) and the University of York will be responsible for directly analysing pseudonymous, individual-level survey datasets generated by the study and conducting follow-up qualitative research with purposive samples of people with dementia and their carers from the cohort.

Mortality data from NHS Digital will be used, where participants agree, to include fact of death, place of death and cause of death as variables in survey datasets. Before being shared with LSE and the University of York, these datasets will be pseudonymised; that is, they will not include personally identifiable data (i.e. name, full address or postcode, date of birth or NHS number) and each participant will only be directly identified in the dataset by their study ID number.

However, LSE and the University of York will be provided with non-pseudonymised data for individuals (including fact of death, place of death and cause of death) to support qualitative recruitment, fieldwork and analyses. The Study Coordinator at the University of Sussex will provide the researchers with contact details for a small number (approx 20-30 per qualitative study) of participants from the cohort of people with a recent diagnosis of dementia and their carers where they meet specified sampling criteria and have given consent to be approached for involvement in follow-up qualitative research.

Cambridge University and Newcastle University

Cambridge University’s and Newcastle University are neither Data Controller or Data Processor. Neither organisation is involved in deciding how data is used, or in gathering or directly analysing data from the cohort of 900 people with a recent diagnosis of dementia and their carers (total of 1800) or consequently, any mortality data obtained from NHS Digital for members of the cohort.

University of Cambridge will provide expert advice and Newcastle University will support consultation and dissemination of findings.

The role of research partners at the University of Cambridge is to provide expert advice on analysis plans for DETERMIND data, based on previous experiences of analysing similar large-scale data sets. Cambridge will not carry out any analyses of the data directly and University of Sussex can choose to either accept or reject any advice provided. They will also advise statisticians on secondary analysis of publicly archived data from the Cognitive Function and Ageing Study (CFAS II), which is a study that was designed to investigate dementia and cognitive decline in a representative sample of more than 18,000 people aged over 65 years, and a further study - the English Longitudinal Study of Aging (ELSA). This secondary analysis is undertaken early on in the DETERMIND project to help generate hypotheses to inform the DETERMIND survey and theory of change framework.

The Economic and Social Research Council (ESRC) are funding the project. The ESRC is the national research council for economic and social research. It has funded the research but plays no role in directing or undertaking the research, and is neither a data controller or processor.

All organisations party to this agreement must comply with the data sharing framework contract requirements, including those regarding the use (and purposes of that use) by “personnel” (as defined within the data sharing framework contract i.e. employees, agents and contractors of the data recipient who may have access to that data).

There will be no data linkage undertaken with NHS digital data provided under this agreement that is not already noted in the agreement.

Data will only be accessed and processed by substantive employees of those organisations who are data processors and will not be accessed or processed by any other third parties not mentioned in this agreement.

There will be no attempts made by The University of Sussex to re-identify individuals involved in this project as there is no requirement to do so.

DETERMIND is a multi-centre research project, funded by the Economic and Social Research Council (ESRC) and led by University of Sussex. Co-applicants on the research grant are University of York, the London School of Economics and Political Science, the University of Cambridge, Newcastle University and clinical consultants (with academic affiliations) in three NHS Trusts (Gateshead Health NHS Foundation Trust, South London and Maudsley (SLAM) NHS Foundation Trust and Sussex Partnership NHS Foundation Trust). The study protocol clarifies, in detail, the roles of these different research partners. In summary:

• The University of Sussex is the sole data controller and is the lead partner within the research team. It is solely responsible for deciding how research data gathered from the cohort of 900 people with a recent diagnosis of dementia and their carers (total 1800) is used. It is also solely responsible for decisions about how mortality data obtained from NHS Digital for members of this cohort is used.

• Gateshead Health NHS Foundation Trust, South London and Maudsley (SLAM) NHS Foundation Trust and Sussex Partnership NHS Foundation Trust (SPFT) will recruit the cohort of 900 people with a recent diagnosis of dementia and their carers (total of 1800) and collect and process participants’ data, on behalf of the University of Sussex and the project as a whole. This will include obtaining and processing mortality data for members of the cohort.

• The University of Sussex, LSE and the University of York will analyse pseudonymised individual-level research (survey) datasets generated by the research project and undertake recruitment, fieldwork and analyses for qualitative research using identifiable data for eligible individuals (meeting sampling criteria and having provided consent to be approached for qualitative research).

• Cambridge University and Newcastle University are co-applicants on the research grant but are not data processors; they play no role in collecting, managing or analysing data gathered from the cohort of 900 people with a recent diagnosis of dementia and their carers, nor the associated mortality data obtained from NHS Digital.

Data management arrangements in DETERMIND in support of these roles

The process for managing the flow of data gathered from and about the 900 people with a recent diagnosis of dementia and their carers (total 1800) is designed to minimise the extent to which research data can be linked to personally identifiable data. This is achieved by ensuring that a clear distinction is made between research data and personally identifiable data, that these are stored separately and by controlling who is able to access each of these two different datasets.

• Pseudonymised research data, identified only by Study ID, will be stored with the data controller (University of Sussex), using REDCap, a secure web application for building and managing online surveys and databases - https://www.project-redcap.org. Research Assistants located at each of the NHS sites will enter pseudonymised research data into REDCap. Once research data has been entered into REDCap, the Research Assistants will no longer be able to access it without contacting the Study Co-ordinator at the University of Sussex. No personally identifiable data will be stored in the REDCap system.

• Direct access to personally identifiable data (participant name, address, date of birth and NHS number) will be limited to authorised staff (Local Principal Investigators and Research Assistants) at Gateshead Health NHS Foundation Trust, South London and Maudsley (SLAM) NHS Foundation Trust and Sussex Partnership NHS Foundation Trust (SPFT. Authorised staff will also have access to participants’ Study ID numbers and thereby comprise the only route through which research data is capable of being re-identified (i.e. de-pseudonymised).

Personally identifiable information will be entered into a locally-held Participant Contact log, which will exist independently at each site. This will also contain additional information concerning contact preferences, consents for NHS Digital data linkage, consents to be contacted about further studies and other meta-data associated with research visits. No research data or information about participants’ health will be stored in the Participant Contact log. This log will be updated as needed (e.g. following survey visits, following any communication or following receipt of notification of death from NHS Digital).

Data management arrangements for processing data from NHS Digital.

Flows out of data into NHS Digital: Research Assistants at the three local NHS sites will send personally identifiable data about members of the cohort of 1800 comprising people with a recent diagnosis of dementia and their carers to NHS Digital quarterly (until the full cohort is achieved), using agreed and authorised methods of data transfer. The legal basis for processing data throughout DETERMIND is GDPR Article 6.1(e) and Article 9.2(j). Consent will be sought from participants to provide their data to NHS Digital for the purposes of data linkage to mortality records and data linkage will not be sought for any participants that do not provide this consent. This is the only time that personally identifiable data will be shared outside of the research team.

Study ID, NHS Number, Date of Birth, Gender and Postcode will be shared with NHS Digital to facilitate linkage.

Flows of data out of NHS Digital: NHS Digital will return mortality data identified by Study ID number to the Study Coordinator at the University of Sussex.

Flows of NHS Digital data within DETERMIND: The mortality data from NHS Digital will remain with the local NHS sites and will not be further circulated. However, it will prompt a number of actions.

• Upon receipt of information concerning someone's death, the locally-held Participant Contact log will be updated

• A REDCap form will also be completed. This will inform the Study Co-ordinator at University of Sussex that a participant has died. The participant will be identified as deceased in the research (survey) dataset, and variables about place and cause of death will also be included in the research (survey) dataset. Participants in the research (survey) dataset are identified by Study ID number only and no personally identifiable information is included. This is the dataset that will be analysed by researchers at University of Sussex, the London School of Economics and Political Science, and the University of York.

• The deceased participant and their carer will be formally withdrawn from the main study (annual face-to-face survey) and from consideration for involvement in associated qualitative research.

There are two reasons for DETERMIND to have the data linkage:

1) To withdraw people from the study so they are not approached inappropriately

2) To invite bereaved carers to participate in relevant linked studies, where they have consented and expressed interest in being informed of further studies (and that they are contacted appropriately in doing so)

All data processing for the study is only carried out by substantive employees of the data processor(s) and or data controller(s) and these employees have been appropriately trained in data protection and confidentiality.

All outputs will contain only data that is aggregated with small numbers suppressed in line with the HES Analysis Guide.

In the DETERMIND study, survey and qualitative data will be gathered from members of a cohort of 900 people with a recent diagnosis of dementia and their carers (total 1800) with a view to better understanding a range of inequalities in dementia care, costs and outcomes. A number of published outputs will be produced and shared using an active public engagement/ communication strategy. The specific publications to be produced will be determined as the project progresses, reflecting the evolving and theory-led nature of the study. The project team are committed to producing multiple peer-reviewed journal papers in high-quality, internationally recognised dementia and social policy journals and various related outputs to reach a range of policy, practice and lay audiences, (including blogs, policy briefings, conference presentations and media interviews and articles). Target audiences are discussed in more detail below. There will be a number of over-arching publications and outputs, covering findings from the project as a whole, as well as specific outputs for each of the seven constituent workstreams. These will be promoted through a dedicated DETERMIND website (https://determind.org.uk), with links from the institutional websites of organisations involved in this study. The project team will work with dissemination partners. In particular, there are funds available to work with the Alzheimer’s Society to promote findings across the Alzheimer's Society networks and website. The project team will also work closely with Making Research Count, a national network of social work and social care departments in 10 English universities with partnerships with local agencies. A summary of planned outputs are as follows:

• An early peer-reviewed journal paper has already been accepted for publication. This is a protocol paper, which summarises for academic audiences the reasons for undertaking the research and describes the research design and methods.

• The project team will prepare descriptive reports of findings after analysis of data from each of the three waves of the longitudinal survey (baseline, wave 2 and wave 3, conducted across 3 consecutive years). These will be written in an accessible format and contain a clear summary of descriptive findings, with use of suitable infographics. These will be posted online and distributed to stakeholders, including to research participants. The project is partnered with the Oxford charity, DIPEx, who are responsible for the highly successful healthtalk.org website that has disseminated text and audio-visual outputs covering more than 100 research studies. DIPEx will develop and manage a dedicated DETERMIND website and produce video and audio summaries for professional and lay audiences. These will be linked to the project team's organisational websites and by the project's dissemination partners, including the Alzheimer’s Society.

• Research partners leading each of the workstreams will produce further high-quality, international peer-reviewed journal papers for academic audiences and other publications for professional and lay audiences in their specific topic areas, with integrated and cross-cutting outputs agreed during the course of the research study as the research evolves.

• At the end of the project, the project team will produce a policy‐based report summarising the findings and associated implications for policy, practice and future research. This will be disseminated as described above, and the project team will hold a major final event, inviting all the stakeholders engaged with throughout including politicians, policy‐makers, academics, carers, people with dementia and the voluntary sector.

• The above policy-based report will be accompanied by fact sheets providing accessible information about the study's overall findings.

• The project team will also produce a guide for the wider public connecting research findings to the everyday life and challenges of people with dementia, families and carers. This guide will include infographics, pictures and real‐life testimonials, thereby contextualising and humanising the academic evidence.

• Findings will be used to update projections of future expenditure on dementia care and update the ESRC-funded MODEM (Modelling the Costs and Outcomes of Dementia) study legacy model (this was previously produced, under a separate grant, by a project team that included team members from the current study, from University of Sussex and LSE) to assist policymakers, commissioners and others to plan services

In all publications, the data will be reported thematically and aggregated with small numbers suppressed. No individual participants taking part in the study will be identified. It is unlikely that any data presented could lead to an individual being identified, however specific efforts will be made to manage this risk by, for example, changing details in examples and quotes presented in qualitative research findings and by suppressing small numbers in reported statistical findings.

The project team will hold seminars and workshops throughout the study to obtain stakeholder views on our plans and emerging findings. They will invite people with dementia, carers, professional staff and stakeholder organisations, including DHSC, NHS England, the Alzheimer’s Society, and the Association of Directors of Adult Social Care. The team members have strong existing links with all these groups. The team also plans to present findings from the research at relevant academic and policy conferences, provide briefings for relevant parliamentary committees, request a special session on the project to be presented at the All Party Parliamentary Group on Dementia and feed into relevant government consultations.

Target audiences for findings from the research include the public, people with dementia and family carers, clinicians and care staff, the third sector, health and social care commissioners, policy-makers, policy networks, groups representing older people and their families, regulatory and other sector-specific bodies, and various knowledge brokers and change agents. Supported with a small dedicated budget from the study, the Alzheimer’s Society will work closely with the DETERMIND team to assist in reaching these audiences effectively and to support the project’s knowledge exchange and communication strategy. The Alzheimer’s Society will also help to facilitate wide stakeholder engagement throughout, including in the annual stakeholder workshops that will be held to make sense of evolving findings (using a theory of change model) to inform development of the study and the specific research questions that will be addressed in successive rounds of analyses. Key organisations that the DETERMIND project team will engage with include the following:

• Association of Directors of Adult Social Services (ADASS),

• Age UK,

• Alzheimer’s UK,

• Carers UK,

• Care and Support Alliance,

• UK Home Care Association,

• Care England,

• Care Quality Commission (CQC),

• Skills for Care,

• Social Care Institute for Excellence (SCIE),

• The National Institute of Health and Care Excellence (NICE) and

• Think Local Act Personal, with whom the research team already, collectively, have strong links.

The DETERMIND research study has been funded by the Economic and Social Research Council (ESRC), following peer review and was consequently assessed against a range of quality criteria including the likely benefits it would provide to health and social care research and provision. In particular, the project will build an evidence base, of new data and theories of change, to inform policy and practice. The overall aims of the study, and of all of the constituent study outputs, are to ensure that findings about costs and about unequal access and outcomes, and the reasons for these inequities, as well as potential solutions and responses are used to inform policy-making and service-planning, as well as the agendas of national organisations seeking to influence policy and practice in dementia care. As detailed in Objectives for Processing, above, these focus on inequities in access to services and what drives these, inequities based on whether self-funding or not, inequities due to psychological factors (e.g. self-esteem), and inequities based on the timing of diagnosis, as well as the costs associated with these different pathways.

The programme will also generate new data, research findings and theory about inequalities in access, outcomes and costs for people with dementia and for their families and carers that will be of key academic interest. This will support and prompt new and innovative research that, in turn, is capable of improving health and social care.

Multiple opportunities for career development and capacity-building have also been built into DETERMIND, with post-doctoral and early career researchers embedded into the research team and two linked studentships. Dementia research and research into social care provision, in particular, are areas where the need for more high-quality research and researcher capacity is widely recognised in order to ensure ongoing research benefit to these sectors is realised.

Yielded Benefits is not a requirement for new applications.