Comprehensive Geriatrician Led Medication Review (CHARMER) Definitive Study

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

Comprehensive Geriatrician Led Medication Review (CHARMER) Definitive Study.

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 has used what the team learned to develop methods to support and encourage proactive deprescribing. The CHARMER team have developed the training, have tested it in a small feasibility study, and are now testing it on a larger scale in this definitive study.

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

In older people's wards the team aim to:

• Develop their approach to increasing discussions with patients about stopping medicines.

• Design and carry out a study testing whether their approach works and is good value for money.

• Raise awareness of discussing medicines stopping in hospital being important.

• Develop a way for getting their approach used in all hospitals.

• See whether hospital reported ethnicity identifiers match with ethnicity reported in NHSE held demographic reported datasets derived from primary care data.

The outcomes are:

• To collect patient oriented outcomes including mortality, number of hospital stays post discharge, satisfaction with deprescribing, medication related side effects, 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 ward discharge, number of prescribed medicines that are stopped, number of prescribed medicines with dosage reduced, and number of medicines stopped that are re-started within three months of hospital discharge.

• Economic outcomes including costs associated with the intervention (primary and secondary care costs in subsample), cost-effectiveness (cost per re-admission avoided), and cost per Quality Adjusted Life Year (QALY).

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.

o Admitted Patient Care – necessary because the research requires the team to know how many times patients were readmitted to hospital following their original visit. (primary outcome for the research project.

o Outpatients – necessary to inform health economic analysis on the potential cost benefit of the intervention.

• Emergency Care Data Set (ECDS) – necessary because the trial is evaluating the health economic impact of readmissions to hospital, therefore this is required to see whether the rates of emergency care change following exposure to the intervention.

• Civil Registration of Death – necessary because the trial is evaluating whether the intervention has any effect on patient mortality rates.

• Medicines dispensed in Primary Care (NHSBSA Data) – necessary because willingness at primary care level to accept deprescribing decisions made in secondary care, therefore the team will link at patient-level the medicines stopped in hospital (collected by the RDN team at the hospital) to the medicines dispensed as recorded in the NHS BSA dataset. Additionally, the cost of these restarted medications will be included in the health economic analysis.

The level of the Data will be:

• Identifiable- as for the consented cohort the applicant holds identifiable information to permit the research team to contact the participant for study activities and if requested, to send a summary of the findings.

The Data will be minimised as follows:

• Limited to a study cohort identified by University of Leicester.

• Limited to participants included in the CHARMER definitive study (at close of recruitment it is anticipated that there will be an approximate total of 42,000 participants.. – Approximately 40,500 participants covered by s251 support (whose data will be processed under this DSA) and approximately 1,500 consented participants (whose data will be processed under DSA ref: DARS-NIC-774351-T6M3Q).

• Limited to data between index admission date – 30/11/2025. For each individual patient, data will only be provided from index admission date the date of inclusion to the 30th November, 1 month post end of follow-up to ensure all data relevant to the intervention period is provided.

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 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 National Institute for Health Research (NIHR) Programme Grants for Applied Research. The funding is for the CHARMER Definitive Study described and the wider CHARMER programme and is not specifically limited to the study described. Funding is in place until August 2026.

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

University of East Anglia (UEA) is a processor acting under the instructions of University of Leicester. Researchers within Norwich Clinical Trials Unit at UEA will be responsible for data storage and analysis. All data servers on which NHSE data will be held are held onsite at UEA.

Cambridge University Hospitals NHS Foundation Trust, University of Leeds, University of Newcastle, University of York, Norfolk and Norwich University Hospital Foundation Trust, University of Exeter, and the University of Sheffield are collaborating organisations who form the Programme Management Group. NHS England, Kings College London, University of Glasgow, and the Academic Centre for Healthy Ageing are collaborating organisations who form the Programme Steering Committee. All will provide advice, support, and guidance in their respective areas of expertise but will not access any data.

Data will only be accessed by substantive employees of Norwich Clinical Trials Unit hosted by University of East Anglia.

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 interpretation of results. The PPI group were a key partner to the discussions which informed this trial design, including using s251 support from Health Research Authority (HRA) Confidentiality Advisory Group (CAG) and routine data from NHS England. The PPI were supportive that the using the s251 approach would:

• Enable efficient delivery of the project.

• Maximise inclusivity of potential participants (patients admitted to older peoples wards) while minimising potential selection bias due to the consent process and/or potential language or cultural barriers.

• Ensure that the research process didn’t unduly add additional burden for either patients or family members during the hospital stay, which in itself can be stressful.

Additionally, the PPI group were reassured that potential participants (and family members as appropriate) would, via posters and leaflets, be advised of the process of opting out of their data being shared for research purposes.

Norfolk and Norwich University Hospital (NNUH) will transfer data to NHS England. The data will consist of identifying details (specifically NHS Number, Date of Birth, Postcode, Admission Date 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, ECDS, Civil Registrations of Death and Medicines Dispensed in Primary Care Datasets to 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 on servers at UEA.

UEA use on-site back-up services provided by the University.

The Data will be accessed onsite at the premises of UEA and 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).

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

Access is restricted to employees or agents of Norwich Clinical Trials Unit at UEA who have authorisation from the study statistician or health economics team.

Employees or agents of Norwich Clinical Trials Unit at UEA are permitted to access pseudonymised data only.

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 person record level data collected as part of the CHARMER definitive study.

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

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

The expected outputs of the processing will be:

· Publications in peer reviewed journals selected to target key stakeholders (Process evaluation manuscripts will be submitted Summer 2025 (protocol) and June 2026 (results). Main trial and health economics manuscripts will be submitted September 2026).

· and publication via the National Institute for Health Research’s own journal library.

· Presentations at appropriate national and international conferences linked to deprescribing, health services research, behavioural science, and patient safety conferences.

· Public facing programme website (charmerstudy.org) to act as a repository for all study outputs, including plain language summaries, ensuring that they are available to the public.

The team will additionally undertake active and passive dissemination activities informed by the Guide to Disseminating Research (GuiDiR). Active strategies include a national deprescribing conference hosted by the CHARMER team, as well as engagement with charity organisations, Royal Colleges, policy makers and regulatory and representative bodies. Passive strategies include social media, blogs, podcast recordings, newsletters, plain language summaries, animations and press releases.

The Public and Patient Involvement group will inform the dissemination activities and its members will play an active role in the format and content of all outputs.

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

• Public facing programme website

Process evaluation manuscripts will be submitted Summer 2025 (protocol) and June 2026 (results). Main trial and health economics manuscripts will be submitted September 2026.

Conference presentations are to be determined but the team anticipate team member attendance at the following: British Geriatrics Society Autumn meeting (November 2025), International Conference on Deprescribing (April 2026) and European Health Psychology Society (August 2025, 2026).

Conference presentations are to be determined but the team anticipate team member attendance at the following: British Geriatrics Society Autumn meeting (November 2025), International Conference on Deprescribing (April 2026) and European Health Psychology Society (August 2025, 2026).

The data are being collected to establish whether the CHARMER intervention is effective at stopping medicines with a greater chance of causing harm than benefit, thereby reducing unplanned hospital admissions. The 2021 National Overprescribing Review established deprescribing as a national priority. The public benefit achieved from the data is that it will inform national policy regarding how overprescribing is managed.

One in two older adults are prescribed a medication with greater chance of causing harm than benefit. This unnecessary prescribing is associated with hospital admissions. Proactively stopping these medicines before they cause harm is recognised by geriatricians and hospital pharmacists as being a part of their role. However, they have identified key challenges to routinely proactively deprescribing. CHARMER is intended to address these key challenges and thereby improve quality of life and health outcomes. The data captured will establish whether the CHARMER intervention has led to medicines being stopped and whether it has reduced unplanned hospital admissions. This in turn will be used to inform national practice in hospitals.

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 definitive study and improve patient outcomes. It is envisaged that if successful, the CHARMER programme will lead to increased proactive deprescribing which in turn will lead to a reduction in side-effects and hospital readmissions due caused by unnecessary medications, thereby leading to an improved 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.

The CHARMER CI and PPI lead have met with several local Healthwatch organisations (n=9) affiliated with trial hospitals to discuss CHARMER, its aims and potential benefit for older adults. The local Healthwatches have agreed to act as dissemination partners and support the study team to share the results with patients.

The CHARMER CI and PPI lead have also formed relationships with organisations who will support adoption and implementation. These organisations represent: geriatricians and pharmacists who will be required to deliver the intervention, including the British Geriatrics Society and Royal Pharmaceutical Society; policy makers who will be required to initiate national change, including the National Director for Prescribing, Clinical Improvement Lead for Medicines Safety at NHS England and the National Patient Safety Commissioner; patient organisations who will advocate for national change, including the National Patients Association and Healthwatch.

Yielded Benefits is not a requirement for new applications.