Pragmatic evaluation of a quality improvement programme for people living with modifiable high-risk COPD (PREVAIL)

The Data will be used for the statistical analyses as part of a research study called PREVAIL Pragmatic evaluation of a quality improvement programme for people living with modifiable high-risk chronic obstructive pulmonary disease . PREVAIL is a cluster randomised controlled trial of the impact of a quality improvement programme (CONQUEST).

CONQUEST is a quality improvement programme (QIP) developed by doctors and health experts to help practices identify and manage patients with modifiable high-risk chronic obstructive pulmonary disease (COPD) according to current guidelines (GOLD, NICE), to help reduce exacerbations and improve clinical outcomes in these patients. COPD is a leading cause of morbidity and mortality worldwide and there is increasing evidence for the link between exacerbations of COPD and cardiovascular events. Effective pharmacological and non-pharmacological treatments are available and there is evidence-based guidance on the management of COPD, yet management is often sub-optimal. Reports suggest that up to 60% of COPD cases are undetected, with many patients only receiving a diagnosis after admission to the hospital for an acute exacerbation and/or having experienced a significant decline in lung function. This suggests that opportunities for earlier diagnosis may have been missed, resulting in an increased risk of exacerbations and an associated potential for an increased risk of cardiovascular events, greater lung function decline, higher mortality rates, and increased health care costs. The CONQUEST QIP aims to close the gap between current COPD care and what guidelines recommend, by driving early identification of high-risk patients and targeted, risk-based treatment with the patient at the centre. The programme will help drive change in the management of patients at risk of COPD exacerbations by imbedding quality standards in routine primary care. The programme is provided at no cost to participating practices by Optimum Patient Care Limited (OPC) through the OPC Quality Improvement and Research Support Services.

The PREVAIL trial is investigating the effectiveness of the CONQUEST programme at reducing COPD exacerbations and/or major adverse cardiac or respiratory events in diagnosed and undiagnosed patients with modifiable high-risk COPD. The trial population includes patients with existing COPD diagnoses and those with potential undiagnosed COPD, primarily focusing on those with existing or newly diagnosed COPD who have a high risk of future exacerbations and potential for their treatment to be optimised with increased COPD medication (referred to as ‘modifiable high-risk COPD’). The trial is sponsored and conducted by Observational and Pragmatic Research International Limited (OPRI UK) for scientific and public health research purposes.

175 general practices in the UK are participating in the PREVAIL trial, with about half randomised to receive the intervention (i.e. CONQUEST QIP) and half continuing to provide usual patient care. As part of CONQUEST, practices in the intervention arm identified relevant patients and optimised their COPD treatment based on clinical recommendations; as such, there were no specific research study visits.

Once the trial outcome evaluation period comes to an end, the data for practices randomised to the intervention and control groups will be compared, to determine the impact of the CONQUEST QIP on the below clinical trial outcomes:

- Rate of moderate/severe exacerbations

- Rate of major adverse cardiac or respiratory events

- Systemic corticosteroid (SCS) use for treating COPD exacerbations

- Explanatory/differential diagnoses amongst undiagnosed patients not diagnosed with COPD following case-finding spirometry

- Rate of unscheduled respiratory care events

- Lung function

- COPD-specific health status

Participating GP practices contribute electronic medical record (EMR) data to the Optimum Patient Care Research Database (OPCRD), with agreements in place for pseudonymised data to be used for ethically approved research. While GP practice EMR data contains all recorded primary care consultations and treatments, it has incomplete information regarding the cause of hospitalisations and deaths. To accurately assess some of the PREVAIL trial outcomes, it is therefore essential to use patient data from two sources: i) GP practice EMR and, ii) secondary care data (Hospital Episodes Statistics, Civil Registrations of Death and, Emergency Care Data Set) supplied by NHS England.

The specific components of the trial outcomes that require NHS England Data are listed below:

- Severe exacerbations (hospitalisation/death for COPD-related respiratory event)

- Major adverse cardiac or respiratory events (hospitalisation for heart failure, non-fatal MI, non-fatal ischaemic stroke, cardiac-related death, respiratory-related death, respiratory-related hospitalisations)

- Unscheduled respiratory care events (respiratory-related A&E attendance, respiratory-related hospitalisation except outpatient)

OPRI UK received funding from AstraZeneca and in-kind support from Optimum Patient Care to deliver the PREVAIL trial.

The independent steering committee includes practicing GPs, secondary care clinicians, academics and patient representatives. All clinical committee members are experts in respiratory care; many of whom contribute to clinical guideline organisations, such as the Global Initiative for Chronic Obstructive Lung Disease (GOLD) and the Primary Care Respiratory Society (PCRS). Thanks to the input of the independent steering committee and the primary care expertise of OPRI UK and OPC, both the trial and the quality improvement programme was designed and implemented to minimise the impact on primary care, while maximising the benefits to GP practices.

All significant findings will be reported in the published trial manuscript, in a peer-reviewed academic journal. The trial independent steering committee will input into the content of the manuscript to ensure that all relevant information in included. Study outputs will only be submitted for publication with their explicit approval.

OPC will transfer two data files to NHS England:

The first file will consist of patient identifiers specifically NHS Number, Date of Birth, Sex and unique Study IDs for the cohort to be linked with NHS England data (i.e. the PREVAIL Cohort).

The second file will be a pseudonymised primary care dataset and unique study IDs for the PREVAIL cohort obtained from the Optimum Patient Care Research Database (OPCRD)

NHS England will process the NHS numbers, DOB and Sex of the PREVAIL Cohort against the required NHS England datasets. Patients who have opted out of data sharing nationally will be removed by NHS England.

NHS England will link HES (APC, CC, OP), ECDS and CRD Data and the Study IDs for the PREVAIL Cohort to create a pseudonymised dataset and will transfer to the SDE.

Following processing by the NHS England SDE team the original file containing the patient identifiers will be deleted. Any copies created during the processing will be made operationally unavailable to the NHS England SDE team and will be archived in line with NHS England Organisational Policy.

NHS England will grant access to the Data via the SDE. The SDE is a secure data and research analysis platform. It allows approved researchers with approved projects access to pseudonymised data and industry leading analytics tools. Pre-specified individuals from OPRI UK will be named as authorised users within the SDE and will access and run study analysis with the Data.

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, OPRI UK.

SDE users can request exportation of aggregated analysis results (suppressed and summarised according to the NHSE SDE Disclosure Control rules) subject to review and approval by the NHS England SDE Output Checking team. The SDE Output Checking team will ensure that no output contains information which could be used either on its own or in conjunction with other data to breach an individual's privacy.

Users must identify themselves via a multi-factor authentication mechanism and are only able to access the datasets detailed within this DSA. The access and use of the system is fully auditable and all users must comply with the use of the Data as specified in this DSA.

Users will be authorised to access the data specified in this DSA and can utilise a variety of analytical tools available within the SDE platform. Users are not permitted to export record-level data from the SDE.

The Data will be stored on servers at NHS England.

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).

The Data will not be linked with any other data other than the GP Primary Care Dataset that will be accessed and linked with the NHS England SDE.

The expected outputs of the processing will be:

- Final study report for the funders and key stakeholders, with a lay summary to participating practices

- Abstracts and presentations at appropriate scientific conferences

- Academic publications in peer-reviewed journals

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

- Conferences

- OPRI UK will make publicly available (i.e. online via the PREVAIL website) a lay summary of the trial and trial results (upon completion of trials analysis) to ensure full public transparency. This will ensure that patients and the public can understand what the data are being used for, the benefits of the study and what those benefits mean to the patient.

- PPIE groups and workshops will be used to review public facing information and materials

For practices participating in PREVAIL, the CONQUEST quality improvement programme will help drive change in the management of patients at risk of COPD exacerbations by imbedding quality standards in routine primary care, and providing healthcare professionals with ongoing education, training and support.

Patients at practices who have implemented the CONQUEST quality improvement programme will receive assessments of individual risk and biological traits to drive optimal management and follow up.

The PREVAIL trial is expected to yield both direct and indirect benefits for science, health and social care. If CONQUEST quality improvement programme (QIP) is found to be effective, patient benefits would include diagnoses of previously undetected COPD, early identification of patients at high-risk of future respiratory and cardiac events and, targeted, risk-based pharmacological and non-pharmacological treatment. Optimising treatment of this high-risk patient population could reduce the risk of future COPD exacerbations and cardiovascular events, reduce mortality rates, and reduce health care costs.

If the QIP is found to be effective, OPC will supply the QIP materials and patient criteria to all practices in the UK, free of charge on the programme website, and will offer the programme free of charge to all practices in the OPC network (currently 1,200 practices, plus any additional that join in the future). As a result modifiable high-risk patients with potential undiagnosed COPD diagnosis could be assessed sooner, and more of those subsequently receiving a diagnosis could receive guideline-based pharmacological and non-pharmacological treatment thus reducing their risk of future respiratory and cardiac events. Furthermore, patients with existing COPD diagnoses could receive more frequent guideline-based monitoring and follow-up, resulting in optimised treatment and/or referrals as appropriate. Optimised clinical management of modifiable high-risk patients with COPD would improve their respiratory- and cardiac-related symptoms, and therefore their quality of life, as well as reduce their use of primary and secondary healthcare.

The CONQUEST QIP is already yielding real benefits to participating GP practices and their patients. Over 1,200 potential undiagnosed MHR patients have received ARTP-assured spirometry (lung function test). In practices randomised to the intervention arm of the trial, CONQUEST has led to 339 newly diagnosed COPD patients, with ongoing work to optimise their care and treatment. This shows that CONQUEST has increased implementation of the NICE guidelines for COPD, and the PREVAIL trial will evaluate whether these clinical activities have changed patient health outcomes. pirometry clinics have also been rolled out to practices in the control arm during the last three months, where approximately 40% of attending patients had spirometry values indicative of COPD.

The use of the data could:

- help to better understand the health and care needs of the modifiable high risk COPD population.

- 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.

- 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).

Yielded Benefits is not a requirement for new applications.