PROSPER Definitive Trial

The University of Leeds (UoL) and Bradford Teaching Hospitals NHS Foundation Trust (BTHFT) require access to NHS England data for the purpose of the following research project:

A definitive, multi-site, individually randomised controlled trial of PeRsOnaliSed care Planning for oldER people with frailty’ (the PROSPER Trial)

The following is a summary of the aims of the research project provided by the University of Leeds and Bradford Teaching Hospitals NHS Foundation Trust:

Frailty is a condition characterised by reduced biological reserves and increased vulnerability to adverse outcomes, including falls, disability, hospitalisation, and care home admission. Older people living with frailty frequently have multiple co-existing long-term conditions, personal predicaments, and social problems. Care for older people with frailty should be proactive and person-centred rather than reactive and disease-focused, and responsive to personal experiences of illness, individual priorities and predicaments. PCP is a promising way to achieve the necessary shift to proactive, person-centred care, however there is a lack of evidence on the effectiveness and implementation of PCP for older people with frailty.

The aim of the PROSPER Trial is to evaluate the clinical and cost-effectiveness of Personalised Care Planning (PCP) for older people with frailty, when compared with usual care alone. The following are the objectives of the PROSPER Trial:

1) To establish whether PCP reduces hospitalisations and overall health care resource use at 12 months post-randomisation.

2) To establish whether PCP is cost effective.

3) To define usual care.

4) To report on deaths occurring in trial participants from date of randomisation until 12 months post-randomisation.

The PROSPER Trial is the final work package in a funded programme of work which commenced in 2017. Although part of a wider programme of work, the PROSPER Trial, for which data is requested, operates under a standalone protocol. The Data requested will be used only for work under the scope of this protocol.

The following NHS England Data will be accessed:

> Hospital Episode Statistics Admitted Patient Care (HES APC)

> HES Accident & Emergency (A&E)

> HES Critical Care (CC)

> HES Outpatients (OP)

> Emergency Care Data Set (ECDS)

> Medicines dispensed in Primary Care (NHSBSA data)

> Civil Registration Mortality data

This Data is necessary to determine the cost-effectiveness of the PCP intervention and the impact on health care resource use, data is required on A&E attendances, unplanned hospital admissions, hospital bed stays, reason(s) for admission, outpatient attendances, medications, and mortality. Cause of death is required in order to fully report on any deaths occurring in trial participants to inform the assessment of safety and outcomes for participants. Date of death is required for the health economic analysis in order to adequately construct Quality-adjusted life year (QALYs) for participants who die.

NHSBSA data is requested to support the cost-effectiveness analysis and descriptive analysis of usual care/treatment services accessed for the participant cohort alongside trial interventions, providing more accurate and complete data than would usually be obtained via participant self-report. NHSBSA data is required to investigate the use of high-cost drugs in particular, which may contribute substantially to the costs of patient care, and identify differences in medication use attributable to the intervention, supporting accurate policy conclusions about whether or not the intervention is cost-effective. In addition, NHSBSA data is requested to investigate whether the support of Personalised Independence Co-ordinators has any impact on prescribing in terms poly-pharmacy or type (e.g., have they led to medication reviews or decrease in anxiety/depression meds).

The level of the Data will be:

> Identifiable

The NHS England Data will not contain directly identifiable information and will be stored separately from the identifying details but both the Statistics and Health Economics teams will have access to both datasets. As such, the Data is listed as identifiable.

The Data will be minimised as follows:

> Limited to a consented study cohort identified by the University of Leeds – the cohort includes 1,337 adults aged 65 or over with frailty, who consented to participate in the PROSPER Trial and were randomised between May 2021 and February 2024. Participants were recruited from GP surgeries in Leeds, Bradford, Wakefield and Mid-Mersey.

> Limited to data between 2020/21 to latest available. For each individual patient, data will only be provided from the date of randomisation (27 May 2021 for the first participant recruited) to the date 12-months after randomisation (27 February 2025 for the final participant). The cohort submission will include the date of randomisation and 12-months post-randomisation for each participant, to ensure data for the relevant trial period only is provided, providing assurance that the minimum data required is obtained.

BTHFT as the research sponsor, and UoL providing the Clinical Trials Unit and coordinating centre for this research, are joint controllers as the organisations jointly responsible for ensuring that the Data will only be processed for the purpose described above.

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

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:

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.

This research is in the public interest since the aim is to provide evidence to inform the delivery of care for older people with frailty.

The funding is provided by the National Institute for Health Research (NIHR). The funding is for the PROSPER programme of work and is not specifically limited to the trial described.

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

Microsoft Limited provides IT hosting services to the UoL and will store the Data as contracted by the UoL.

The PROSPER programme of work is a multidisciplinary, academic collaboration between BTHFT, UoL, The University of Manchester, Age UK, Westcliffe Health Innovations and the University of Exeter. The University of Exeter will not be in receipt of data requested under this application, nor have control over the data and are not responsible for its processing.

The University of Manchester employs the co-Investigator and researchers responsible for recruitment and follow-up activity within the North West Hub.

The Age UK teams are responsible for delivering the trial intervention in accordance with the study protocol.

Westcliffe Health Innovations employs a GP collaborator who allowed UoL to recruit participants from their sites. This individual has no other role in the study and has no access to the NHS England Data.

The University of Exeter employs the lead Health Economist who will not have access to NHS England Data.

Public and Patient representatives have been involved throughout the trial to help refine the purpose of the research and review trial processes, and support the collection of the data for the purposes described above.

The University of Leeds will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth and Gender) for the cohort to be linked with NHS England data. The University of Leeds will also transfer a date of randomisation and a unique person ID for each cohort member to NHS England.

NHS England will provide the relevant records from the HES, ECDS, NHSBSA and deaths datasets to the CTRU at the University of Leeds. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the recipient.

Upon receipt of data from NHS England, the trial statistician at CTRU will transfer the data into a secure folder prior to using in statistical software for analysis. The University of Leeds will also extract a subset of the Data specified in the Health Economics Analysis Plan and make this available to the trial health economist by transferring the data, via Secure Electronic File Transfer, to the Leeds Analytics Secure Environment for Research (LASER) platform at the Leeds Institute of Data Analytics, University of Leeds.

The Data will not be transferred to any other location.

The Data will be stored on servers at the University of Leeds.

UoL stores Data on the Cloud provided by Microsoft Limited.

The Data will be accessed by authorised personnel via remote access.

The Controller(s) must confirm and provide evidence upon audit by NHS England that access via any remote device complies with the data security obligations within this DSA and the Data Sharing Framework Contract.

For remote access:

- Remote access will only be from secure locations situated within the territory of use (as further restricted elsewhere within the DSA if so done) stated within this DSA;

- Access controls granting users the minimum level of access required are in place;

- Remote access is only via secure connections (e.g., VPNs or secure protocols) to protect data;

- Multifactor authentication (MFA) is required for remote access;

- Device security, including up-to-date software and operating systems, antivirus software, and enabled firewalls are utilised for the remote access;

- All remote access is undertaken within the scope of the organisation’s DSPT (or other security arrangements as per this DSA) and complies with the organisation’s remote access policy.

The above applies in addition to any condition set out elsewhere within the DSA (e.g. who may carry out processing, and for what purpose).

Remote processing will be from secure locations within England. The data will not leave England at any time.

Access is restricted to employees of the University of Leeds who have authorisation from the Principal Investigator.

BTHFT is not permitted to access the Data.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will be linked at person record level with clinical data and participant-reported outcome measures trial data for the cohort held at the CTRU, obtained from participant-reported outcome measures and health care records.

The Data will not be linked with any other data.

The identifying details will be stored in a separate database to the linked dataset used for analysis. All analyses will use the pseudonymised dataset.

Researchers from the University of Leeds will process the Data for the purposes described above.

The expected outputs of the processing will be:

> A report of findings to the trial funder (NIHR)

> Submissions to peer reviewed journals, including the NIHR journal series and peer reviewed international general medical journal(s)

> Presentations at key national (e.g., British Geriatrics Society; Royal College of General Practitioners Annual Conference) and international conferences (e.g., International Association of Geriatrics and Gerontology)

> Presentations and informal discussion at voluntary agency events

> Contributions to local community group newsletters

> A lay summary to be provided to all participants, and their carers

> A short summary of the results will be made available and distributed to all participating sites.

> A lay summary for the trial website

> Summaries for Age UK and participating research teams

> Resource to support commissioning, including an Implementation toolkit consisting of intervention materials, training materials, and a mechanism to measure impact

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 be communicated to relevant recipients through the following dissemination channels:

> Presentations at local and international conferences

> Press releases, for example through the University of Leeds press office

> Presentations and informal discussion at voluntary agency events

> Contributions to local community group newsletters

> Talks, meetings and workshops will be organised as appropriate with involvement from local lay, clinical and professional groups with each co-applicant taking responsibility for dissemination within their specialty.

> Social media, including Twitter and online blogs

The final report and associated publications are expected from September 2025.

The PROSPER Trial is expected to provide robust evidence on the clinical and cost-effectiveness of an optimised PCP intervention, suitably targeted for older people with frailty.

Based on established estimates of frailty prevalence, there are likely to be approximately 1 million older people living with frailty in the UK. Older people with frailty are at increased risk of disability, hospitalisation and care home admission and are recognised as core users of NHS and adult social care services. A successful PCP intervention to improve quality of life in older age and reduce use of NHS and adult social care services has potential for considerable impact at an individual and societal level.

The use of the data could:

> lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience.

> inform planning health services and programmes, for example to improve equity of access, experience and outcomes.

> inform decisions on how to effectively allocate and evaluate funding according to health needs.

> support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

The alignment of contemporary national policy with robust research evidence and implementation tools means that the University of Leeds are in a strong position to realise NHS benefits in a short timescale.

Findings will also be disseminated through the national frailty collaborative, NHS England through the National Clinical Director for Older People and Integrated Care, Integrated Care Systems, Age UK and the British Geriatrics Society.

A dissemination strategy has been developed, which includes a purposely designed programme website, regular newsletters and social media. The study team maintain a Twitter account and online blogs to provide project updates and will provide a summary of the final results. The University of Leeds will work with their PPI Frailty Oversight Group, PPI co-applicant and Age UK to tailor the findings to the needs of different stakeholders and disseminate them through a series of lay summaries, presentations at conferences, including PPI-focussed conferences, and academic peer reviewed papers.

Yielded Benefits is not a requirement for new applications.