CompreHensive geriAtRician-led MEdication Review (CHARMER) Feasibility Study

The University of Leicester requires access to NHS England Data for the purpose of the following research project: CompreHensive geriAtRician-led MEdication Review (CHARMER) Feasibility Study.

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

"The CHARMER (CompreHensive geriAtRician led MEdication Review) research programme is a series of interlined work packages with the aim to develop and test a way to support geriatricians (doctors working on older people’s medicine wards) and hospital pharmacists to proactively deprescribe medicines for older people whilst they are in hospital. There is an expectation from patients and carers that prescribed medicines have been reviewed for appropriateness and any inappropriate medicines stopped.

The CHARMER intervention is a behaviour change intervention targeting NHS geriatricians and pharmacists in hospitals to address the barriers and enabler to proactive deprescribing.

The research team has already explored the reasons why geriatricians and hospital pharmacists do not proactively deprescribe for older people by working with doctors, pharmacists and patients. The CHARMER feasibility study have used what we learned to develop methods to support and encourage proactive deprescribing. The CHARMER team have developed the training and are testing it in this small feasibility study. The findings from the CHARMER feasibility study will be used to inform a definitive randomised controlled trial (RCT), including on a larger number of doctors and pharmacists. This is due to start towards the end of 2023.

The CHARMER feasibility study will collect a range of outcomes including:

• Patient oriented outcomes including mortality, satisfaction with deprescribing, medication related adverse drug events, and health-related quality of life (HRQoL).

• Process outcomes including number of regularly prescribed medicines at ward discharge, number of prescribed medicines for ‘when required use’ at discharge, number of prescribed medicines that are stopped, number of prescribed medicines with dosage reduced, whether medicines stopped at discharge remain stopped post-discharge.

• Economic outcomes including number of hospital stays, and length of hospital stay for index admission.

• Number of eligible participants, any recruitment bias characterised by differences in demographic data between consenters and non-consenters, the proportion of patients for whom data are available at 0 and 120 days post discharge, ceiling and floor effects for each outcome – these will guide identification of the most suitable outcomes for the definitive RCT.

NHS England Data will be used to inform the process and economic outcomes listed above".

The following NHS England Data will be accessed:

• Hospital Episode Statistics – Admitted Patient Care – necessary to identify reasons for admission to hospital for Older People taking part in the CHARMER study. This information will also be used to calculate the number of hospital stays and length of hospital stay for index admission to inform the economic analysis. Method of discharge will be used to verify whether Older People taking part in the Study died in hospital.

• Medicines Dispensed in Primary Care (NHSBSA Data) – necessary to identify medication changes initiated in the community after participants are discharged from hospital, to determine whether deprescribing was sustained during the intervention period.

The level of the Data will be:

• Pseudonymised.

The Data will be minimised as follows:

• Limited to 272 patients admitted to Older People’s Medicine wards participating in the CHARMER study from between 04/07/2022 to 31/10/2022. Patients who died in hospital, and those who did not have a discharge date (i.e. were still in hospital at the start of the follow-up period) are excluded.

• Limited to data until 120 days after the discharge date.

University of Leicester is the research sponsor and 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 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 National Institute for Health Research (NIHR) Programme Grants for Applied Research. The funding is for the CHARMER Feasibility Study described and the wider CHARMER programme. Funding is in place until July 2025.

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

The University of East Anglia is a processor acting under the instructions of University of Leicester.

Norfolk and Norwich University Hospital (NNUH) will submit the cohort to NHS England.

Cambridge University Hospitals NHS Foundation Trust, University of Leeds, University of Newcastle, University of York and the University of Sheffield are collaborating organisations who form the Programme Management Group. They provide advice, support and guidance in their respective areas of expertise.

Data to be accessed by substantive employees of the UEA.

A Patient and Public Involvement (PPI) representative is a co-applicant. The PPI Group are active partners in decision making for all aspects of the project including study design, developing public facing communications, and data collection and handling. The PPI group support the use of s251 support from Health Research Authority (HRA) Confidentiality Advisory Group (CAG) and routine data for this from NHS England to efficiently deliver this project.

NNUH will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode and 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 and Medicines Dispensed in Primary care datasets to the University of East Anglia (UEA). 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.

The Data will not be transferred to any other location.

The Data will be stored at Norwich Clinical Trials Unit server at UEA. The Data will be backed-up to servers based at the UEA.

The Data will be accessed by authorised personnel on site at the premises of UEA and 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).

The data will not leave England at any time.

Access is restricted to individuals within the Norwich Clinical Trials Unit at UEA who have authorisation from the study statistician or health economics team. Access is to pseudonymised data only. All such individuals are substantive employees of UEA.

University of Leicester 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 other data collected as part of the CHARMER feasibility study.

NNUH hold identifying details. All analyses will be performed at the Norwich Clinical Trials Unit at UEA and will use the pseudonymised dataset from NHS England and The CHARMER study linked only by study ID.

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

Statisticians and health economists from the UEA and The Norwich Clinical Trials Unit will analyse the data for the purposes described above.

The expected outputs of the processing will be:

• Used to inform the methods, processes and analysis of the definitive RCT that is being taken as part of the overarching CHARMER programme. The definitive RCT will use the same data sources, and therefore the feasibility data will be used by statisticians and health economists ahead of receiving the definitive RCT data to set-up procedures and programme analyses

• Publication of peer reviewed journals, including publication via the National Institute for Health Research's own journal library.

• Presentations at appropriate conferences inked to deprescribing, health services research, behavioural science and patient safety conferences. .

• Patient and Public Involvement Group will inform the dissemination strategy and its members will play an active role in the format and content of academic papers (specifically patient implications) and will present at local, regional and national conferences and wider stakeholder meetings.

• Publication of a public facing programme website to act as a repository for all study outputs ensuring that they are available to the public.

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:

• Journals

• Social media

• Press/media engagement

• A public facing programme website

A manuscript of the CHARMER feasibility study protocol including site-set up procedures was published in BMJ Open in August 2023. This highlighted the use of using routinely collected data without patient consent to establish effectiveness and how this can be used in research to collect data on deprescribing practices. Results from the feasibility study will be published in open access and peer reviewed journals, including publication via the National Institute for Health Research's own journal library. Results will also be presented at relevant conferences linked to deprescribing, health services research, behavioural science and patient safety conferences.

The Patient and Public Involvement Group will inform the dissemination strategy and its members will play an active role in the format and content of academic papers (specifically patient implications) and will present at local, regional and national conferences and wider stakeholder meetings.

The target dates for production and dissemination of the outputs is by Autumn Spring 2024.

The findings of this feasibility study are expected to inform the development of processes and analyses used in the definitive RCT to develop and test a way to support geriatricians (doctors working on older people’s medicine wards) and hospital pharmacists to proactively deprescribe for older people whilst they are in hospital.

The use of the data could:

• Address proactive deprescribing in hospitals.

• Lead to the identification or improvement of treatments to improve health and care outcomes.

It is hoped that as an outcome of the findings that older people prescribed medicines, whereby risk outweighs harm, may benefit from having their medicines stopped during the feasibility study and improve patient outcomes.

It is envisaged that if successful, the CHARMER programme will lead to increased proactive de-prescribing which in turn will lead to a reduction in side-effects and hospital readmissions due caused by unnecessary medications, thereby leading to an improves quality of life. In turn, there is a potential cost saving to the NHS by reduction in NHS services by reduced hospital admissions and lower medication use.

The CHARMER study will create a public facing programme website to act as a repository for all study outputs ensuring that they are available to the public. There is also a newsletter on the CHARMER study website available for the public to access (https://mailchi.mp/f552e14f9125/charmer-highlights).

Not stated in the register.