Predictive Risk Stratification Models: Assessment of Implementation Consequences (PRISMATIC 2)

Swansea University requires access to NHS England data for the purpose of the following research project:

Predictive Risk Stratification Models: Assessment of Implementation Consequences (PRISMATIC 2)

The following is a summary of the aims of the research project provided by Swansea University:

PRISMATIC 2 aims to determine the effects of the introduction of Emergency Admission Risk Stratification (EARS) tools across all patients and in subgroups including those with Ambulatory Care Sensitive (ACS) conditions (conditions where effective community care and person-centred care can help prevent the need for hospital admission) on:

• Emergency admissions

• Emergency Department (ED) attendances

• Admissions to Intensive Care Units (ICU)

• Time spent in hospital (bed days) and ICU

• Deaths

• NHS costs

PRISMATIC 2 is a stand-alone research project that consists of 4 separate work packages. The data requested in this Agreement concerns Work package 1 only.

The PRISMATIC 2 Work packages are described below:

> WP1: Pseudonymised routine linked data analysis - Using routine data sources (HES supplemented by ONS & ECDS, via NHS England), Swansea University will analyse routine anonymised data on emergency admissions, ED attendances and days spent in hospital and in ICU at study site (CCG) level between 2010 and 2021, linked to the dates of introduction of predictive risk stratification

> WP2: Investigation of mechanisms of change using routine anonymised primary care data - effects on thresholds for emergency admission decisions and case mix by examining characteristics (demographic and clinical) will be explored, and, in particular, severity of condition of patients admitted before and after introduction of the software, across the population and in subgroups

> WP3: Semi-structured interviews with practitioners - Swansea University will undertake qualitative work at 8 practices, selected from the original sample of 16, to investigate whether practitioners perceive that primary care clinicians’ attitudes to risk and/or decision-making behaviour changed with introduction of predictive risk software.

> WP4: Focus groups and interviews with patients - Swansea University will undertake qualitative work with patients (n=32), split between focus groups and interviews, to explore how they perceive that communication of individual risk scores might affect their experiences and health seeking behaviours.

The following NHS England Data will be accessed:

> Hospital Episode Statistics (HES)

- Admitted Patient Care (APC) – necessary to assess trends in emergency admissions pre vs post EARS implementation by obtaining data on admissions, diagnoses, as well as treatments and investigations (linked to the severity of cases).

- Accident & Emergency (A&E) and Emergency Care Data Set (ECDS) – necessary to assess trends in A&E attendances pre vs post EARS implementation. A&E attendance data will facilitate the study evaluation to whether the implementation of EARS tools was associated with intended or unintended changes in emergency department utilisation across England.

- Critical Care (CC) - necessary to assess trends in admissions to intensive care units and length of ICU stay pre vs post EARS implementation, which are important study outcomes related to the severity of illness.

> Civil Registration Mortality – necessary to assess trends in deaths pre vs post EARS implementation, which is an important study outcome, given that EARS tools aimed to reduce risk of adverse events such as mortality.

The level of the Data will be:

> Pseudonymised

The Data will be minimised as follows:

> Limited to data between 2009/10 and 2020/21; this data period is required as it covers the period in which software tools were introduced across some CCGs in England (~2012/13 – 2016/17; varies across regions), plus three years before and four years after their implementation. This is to allow Swansea University to study the trends in data before and after the intervention was introduced.

> Data required on the whole of England. By analysing data for the whole of England, the large number of former Clinical Commissioning Group (CCG) areas that implemented EARS tools at different times will provide greater statistical power for the Multiple Interrupted Time Series (MITS) analysis. Analysing data for the whole of England facilitates evaluation to whether the effects observed in their previous single-site PRISMATIC trial (conducted in South Wales) are replicated more broadly across England over a longer follow-up period.

Swansea University is the controller as the organisation 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.

Emergency admissions and acute healthcare utilisation place a significant burden on the NHS and have major cost implications. Assessing interventions aimed at reducing unnecessary emergency admissions, such as EARS tools, is in the public interest as it can inform more efficient and effective use of limited NHS resources. The findings from this study, concerning the impacts of implementing EARS tools across England, is expected to provide much needed evidence to inform future policy decisions by NHS England. Additionally, the study findings could be used to inform policy and practice regarding the continued use or refinement of EARS tools across the UK.

The funding is provided by the National Institute for Health Research (NIHR). The funding is specifically for the project described.

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

Swansea University are strongly committed to the involvement of patients and the public in PRISMATIC 2. The UK Standards for Public Involvement will be followed throughout the study. Patient/public contributors and study co-applicants were substantively involved in the development of the study design and two risk stratification focus groups were held with members of the SUPER (Service Users for Primary and Emergency care Research) group and the SAIL (Secure Anonymised Information Linkage) Consumer panel.

No data will flow to NHS England for the purposes of this Data Sharing Agreement (DSA).

NHS England will provide the relevant records from the HES, ECDS and mortality datasets to Swansea University. The Data will

> contain no direct identifying data items. The Data will be pseudonymised and individuals cannot be reidentified through linkage with other data in the possession of the recipient.

The Data will not be transferred to any other location.

The Data will be stored on the UK Secure e-Research Platform (UK SeRP), a Trusted Research Environment (TRE), at Swansea University. The Data will be stored in isolation from other datasets held by UK SeRP, as per UK SeRP policy.

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 and Wales. The data will not leave England or Wales at any time.

Access is restricted to employees of Swansea University who have authorisation from the Chief Investigator.

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

The Data will not be linked with any other data.

There will be no requirement and no attempt to reidentify individuals when using the Data.

Researchers from Swansea University will analyse the Data for the purposes described above.

The expected outputs of the processing will be:

> Submissions to peer reviewed journals, specifically the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research (HS&DR) journal

> Briefing papers

> Presentations at relevant conferences (e.g. Society for Academic Primary Care, Royal College of General Practitioners, British Journal of General Practice, Health Services Research UK)

> A public facing lay summary of findings

> A logic model describing the intended and unintended effects of predictive risk stratification tools, the mechanisms by which these effects might be achieved, and the inputs (context and resources) which lead to these effects

> Two dissemination workshops: one aimed at policy and practice stakeholders, and a second aimed at public/patient stakeholders, in partnership with the SUPER PPI group and the Patients and Public Participation Groups (PPGs) Network

> A publication and dissemination plan will be developed within the Research Management Group, including the assessment of stakeholder needs and communication activities and milestones, and results will be actively published throughout the research funding period. The plan seeks to maximise stakeholder interest and understanding of the study and outputs. This plan will inform ongoing engagement with patients, clinicians, managers, commissioners and policy makers, using appropriate communication messages and platforms. PPI collaborators will be worked with to ensure patient-focused materials are widely understood

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

Outputs are expected to be produced within 12 months of data receipt.

The findings of this research study should give policy-makers, healthcare professionals, patients and carers, a better understanding of the effects and costs related to the introduction of emergency admission risk stratification (EARS) tools in England. The use of the requested NHS England Data will:

• enable assessing the effects of the introduction of EARS tools across all patients and in subgroups (including those with Ambulatory Care Sensitive conditions) on: emergency admissions, Emergency Department attendances, admissions to Intensive Care Units (ICU), time spent in hospital (bed days) and ICU, deaths and NHS costs;

• advance understanding of the effectiveness of using preventive care measures such as the implementation of risk stratification tools and provide evidence about the processes and outcomes of their use;

• inform decision making on future policy decisions.

The use of the data could:

> help the system to better understand the health and care needs of populations.

> advance understanding of regional and national trends in health and social care needs.

> advance understanding of the need for, or effectiveness of, preventative health and care measures for particular populations or conditions such as obesity and diabetes.

> 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.

> provide a mechanism for checking the quality of care. This could include identifying areas of good practice to learn from, or areas of poorer practice which need to be addressed.

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

From the patients' perspective, it is important to reduce emergency admissions to hospital. Emergency admissions are generally unwelcome to the patient; they can be associated with adverse outcomes including death, frailty and difficulties regaining independence; and are challenging to manage in terms of quality and safety (e.g. exposure to hospital acquired infections). Although predictive risk stratification has been advocated as one tool to help support reductions, its impact and worth as a policy option remains unclear. This research study will investigate effects (including those unexpected and unintended), on emergency admissions to hospital, Emergency Department attendances and days spent in hospital, associated with the introduction of predictive risk stratification software.

Through publication of findings, including peer-reviewed journal articles and health service research and policy events, this research is expected to provide policy-makers with the evidence needed to inform future policy decisions on the use of predictive risk stratification tools in primary care.

Yielded Benefits is not a requirement for new applications.