EXTEND Study: Needs-Assessed Care for Early Psychosis

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

EXTEND Study: Needs-Assessed Care for Early Psychosis

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

The EXTEND study team are researchers from universities across the UK, led by the Chief Investigator from the University of Oxford.

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

'The purpose of this research is to investigate the impact of alternative durations of Early Intervention in Psychosis (EIP) care on service users’ health outcomes. This will include understanding and contextualising the existing variations in the duration of EIP care provided and service user outcomes, and estimating the cost-effectiveness of an alternative, flexible, needs-assessed EIP service. To do this, the study team proposes to create and analyse a pseudonymised dataset linking routine health service data from NHS England, to a clinical audit dataset held by the Royal College of Psychiatrists (National Clinical Audit of Psychosis- NCAP).'

Early Intervention in Psychosis (EIP) services are phase-specific, multidisciplinary, community-based mental health teams that treat people who are experiencing, or who have recently experienced, their first episode of a psychotic illness. EIP services are the principal pathway for the treatment of an emergent psychosis in the NHS in England.

It is not known what the optimal length of treatment should be for individuals within EIP services. It is not known whether the length of treatment, in itself, improves or reduces the chance of a ‘good’ outcome. The majority (58%) of individuals with First Episode Psychosis (FEP) will have an initial remission of their symptoms after the first episode of psychosis and 38% will reach eventual symptomatic and functional recovery. There is also a significant proportion who do not reach remission nor recovery criteria after their FEP, representing 3000 people a year in England. Furthermore, there is a range of illness trajectories following a first episode, meaning the eventual outcome is not easy to predict at the beginning of the illness.

Given this range of possible outcomes and trajectories, it is likely that a flexible, needs-focused treatment is required for those who experience FEP, rather than the current standard package of 3 years of assertive community treatment for everyone. It is possible, therefore that some people would benefit from longer treatment within EIP to help sustain the improvements made in the first few years. Conversely, it is possible that the length of treatment in itself is not relevant, but it is the delivery of NICE-recommended treatments that is the most effective component of treatment, which could be delivered over a shorter timeframe.

The following NHS England Data will be accessed:

• Hospital Episode Statistics

o Admitted Patient Care (APC)

o Accident & Emergency (A&E)

• Emergency Care Data Set (ECDS)

• Mental Health

• Civil Registration Mortality

The Data will be linked with the pseudonymised records from the National Clinical Audit of Psychosis (NCAP). The linked dataset will provide data on a large representative cohort of patients receiving care from EIP services, together with detailed data on health service use and outcomes. This will allow an analysis of the objectives of the EXTEND study - the impact of the duration of EIP care on outcomes.

The level of the Data will be:

• Pseudonymised

The Data will be minimised as follows:

• Limited to data for a study cohort identified from NCAP data in 2019/20 and 2020/21 which the Royal College of Psychiatrists will provide to NHS England.

• Limited to data between 2016/17 and latest available at the time of dissemination (expected in 2023).

The University of Oxford 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.

This processing is in the public interest because it adheres to the UK Policy Framework for Health and Social Care Research, which protects and promotes the interests of patients, service users and the public, and aims to produce generalisable and publicly available information to inform future decisions over patients’ treatments or care.

The funding is provided by the National Institute for Health Research (NIHR). The funding is specifically for the EXTEND study - Personalised Care for Early Psychosis, funding is in place until May 2025.

Cardiff University and Imperial College London (co-investigators on the EXTEND project) will be processors acting under the instructions of the University of Oxford.

The Office for National Statistics (ONS) is a processor. The role of ONS role is limited to hosting and providing access to the NHS England data in their Secure Research Service (SRS). ONS will receive the NHS England data and will upload it to the Secure Research Service (SRS). NHS England data will not be stored on any premises other than those of the Office for National Statistics.

Other co-investigators on the project (including from Pennine Care NHS Foundation Trust, Leeds and York Partnership NHS Foundation Trust, Keele University, Centre for Mental Health and Manchester Metropolitan University) do not require access to the NHS England data and do not determine the means and purposes for processing for this specific study. These institutions are conducting qualitative, policy or project management work as part of the broader NIHR grant. This includes a Manchester Metropolitan University (MMU) professor who is the co-chief investigator (and is therefore listed as leading the project on publicly available material, including the privacy notice) but does not determine the means and purposes for the processing in this agreement.

This EXTEND study is part of an overall programme of research funded through the NIHR through a Programme Grant for Applied Research (PGfAR) and for which the Professor from MMU is Programme Chief Investigator. There are several work packages that different universities are leading, and this study is being led by the Professor from University of Oxford as Chief Investigator for this specific study. Therefore, whilst the Professor at MMU has responsibility for the overall programme of research, for the purpose of this specific processing Oxford University is the sole data controller.

Data will be accessed by a PhD student affiliated with Imperial College London. The individual has completed mandatory data protection and confidentiality training and is subject to the University of Oxfords' policies on data protection and confidentiality. The individual accessing the data will do so under the supervision of a substantive employee of Imperial College London. Imperial College London would be responsible and liable for any work carried out by the individual. The PhD student would only work on the data for the purposes described in this Agreement.

Royal College of Psychiatrists will transfer data from NCAP to NHS England. The data will consist of identifying details (specifically NHS Number, age, gender, and partial postcode) along with a unique person ID for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the HES APC, HES A&E, ECDS, MHSDS, and Civil Registration Deaths datasets to ONS. 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

Royal College of Psychiatrists will also send directly to ONS the same unique person ID with their pseudonymised NCAP data which the EXTEND study team will then use to link to the NHS England Data via the unique person ID.

The Data will be stored on servers at ONS.

The Data will be accessed onsite at the premises of ONS.

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

The Controller 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).

The Data will not leave England/Wales at any time.

Access is restricted to employees or agents University of Oxford, Imperial College London and Cardiff University who have authorisation from the University of Oxford 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 the University of Oxford, Cardiff University, and Imperial College London will analyse the Data for the purposes described above.

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 datasets from which the information was derived.

The outputs of the processing will be national-level aggregates and modelling. Some statistics will be reported at the EIP team level (<100 individuals). Statistical disclosure risk for small numbers will be managed in line with the ONS protocols on disclosure risk for health data.

The expected outputs of the processing and how they will be communicated to relevant recipients through the following dissemination channels:

- Interim reports to the funder on the progress of data linking and causal inference.

- End of programme reports to the funder on each of the key work packages: understanding existing duration in EIP care; causal impact of different durations of EIP care on patient outcomes; cost-effectiveness of alternative duration EIP provision.

- Submissions to open-access peer-reviewed journals (e.g. Lancet Psychiatry or British Journal of Psychiatry).

- Presentations at national and international conferences (e.g. International Early Intervention Association / International Congress of The Royal College of Psychiatrists).

- Specific reports on findings for healthcare policymakers.

- Guidance for EIP service providers to aid in the development of a national implementation strategy if the intervention is found to be effective.

Production of policy-focused and Patient and Public Involvement (PPI)-focused outputs (such as blogs, videos, briefings and short reports) will be ongoing throughout the course of the funded project period (June 2022 to May 2025). The funder requires interim reports at 9 months and 18 months. Final reports, including journal submissions, are intended to be completed by the end of the funded project period (May 2025).

The findings of this research study are expected to contribute to evidence-based decision-making for policymakers, and local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment, and experience of healthcare users relevant to the subject matter of the study.

The use of the data could

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

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

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

• 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 that need to be addressed.

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

This study intends to estimate the impact of alternative models of provision of Early Intervention in Psychosis care. If it finds that extended, or more flexible, duration of EIP care benefits patients experiencing First Episode Psychosis (FEP) and is cost-effective, it could guide the direct improvement of the National Health Service (NHS).

Evidence generated from the study may have relevance to tens of thousands of people with a diagnosis of psychosis. Furthermore, the data generated has the potential to impact on their carers, clinicians, service managers and Integrated Care Boards (ICBs).

Through the publication of findings in appropriate media, the findings of this research may add to the body of evidence that is considered by the bodies, organisations, and individual care practitioners charged with making policy decisions for or within the NHS or treatment decisions in relation to specific patients.

The linked NCAP data and NHS England data may be suitable to be used as a resource for future research into care for early psychosis, subject to the required approvals.

EXTEND is an NIHR-funded Programme Grant for Applied Research. EXTEND is investigating the optimal duration of Early Intervention in Psychosis (EIP) services, a key mental health research priority. The funder has approved an extension to the project end date to allow additional time to complete analysis and reporting.

The main outputs to date include a number of papers based on qualitative interviews with service users, carers and professionals. These papers describe the variation in EIP provision, the importance of care coordinators and the challenges of returning to primary care after EIP. Ultimately, service users and carers value personalised care.

Continuing access is needed to finalise analysis and write up the findings, as well as conduct a more comprehensive investigation of the factors driving EIP care duration, including available resources and service engagement.