Integrating service, audit and research data to improve patient care

The aim was to develop an IT solution to deliver the following key objectives:

• Data capture of detailed longitudinal clinical parameters amongst patients attending (i) the early arthritis clinic (EAC), (ii) monthly nurse-led DMARD escalation clinics, (iii) annual review clinics and (iv) biologics clinics, meeting both research and audit requirements.
• Interface with electronic clinical records system, enabling extraction of blood samples results (e.g. ESR for automated DAS28 calculation).
• Automatic letter generation, whereby records of all encounters in nurse-led clinics (including disease activity measures) are summarised in paper format suitable for primary care communication, without the need for dictation or typing.
• Robust information governance, including appropriate security and a mechanism whereby anonymised clinical data on consenting individuals from whom biological samples are obtained may be accessed by non-clinical laboratory researchers, and samples catalogued to ensure Human Tissue Act compliance.

The purpose of the initiative was to address parallel challenges faced by our tertiary rheumatology service, namely:

• Achieving national policy benchmarks for the management of rheumatological conditions;
• Participating fully in complex National Clinical Audit;
• Enhancing opportunities for patients to engage with productive research, including clinical trials;
• Achieving these objectives whilst limiting departmental spending.

National policy demands meeting benchmarks for the management of rheumatic conditions and participation in complex National Clinical Audit. However, data management is becoming increasingly complex for busy medical departments active in research and audit, with no one size fits all approach available. Patients also need opportunities to engage with productive research, including clinical trials. IT solutions to meet the above challenges, whilst limiting departmental spending, are therefore needed.

The team developed a bespoke database called ‘Earth’ (early arthritis), which is hosted by the Trust and linked to a separate database on the university servers. Earth is managed by a dedicated database manager who is a member of the rheumatology department and therefore integrated with the clinical team.

• Earth complies with data protection requirements, adheres to Caldicott guidelines, and for research samples ensures compliance with the Human Tissue Act (HTA). It also interfaces with the existing Trust eRecords system, enabling extraction of blood samples results.
• Earth allows real-time input of detailed specialty-relevant data by staff, such as demographics, outcomes and medications; each member of clinical, clerical and research staff have an appropriate level of access.
• The database was introduced to end-users, including nursing, medical and research staff during several interactive, introductory and teaching sessions delivered by the project lead and the database manager. It has become an integral part of the department with widespread support at all levels within the department and the Trust.

It is routinely used:

• To monitor the established cohort of ~4,000 RA patients for audit (and research with appropriate consent), including full use within the early arthritis clinic (EAC) and the annual review clinics.
• In the biologics clinic to facilitate audit and identify suitable patients for clinical trials, and the juvenile idiopathic arthritis service for audit.
• For automatic letter generation to record all encounters in nurse-led clinics (including disease activity measures) are summarised in paper format suitable for primary care communication, without the need for dictation or typing.

Service Performance and Outcomes

Enhanced capacity for clinical audit

The proportion of newly diagnosed RA patients achieving moderate or good EULAR responses during the first 2 months of treatment increased from 59% to 75% between 2013 to 2014 calendar years

Cost neutral

Earth is approximately cost-neutral but brings added value for audit, research and quality improvement. In recognition of Earth’s value to the department, and the potential to expand its scope into other sub-specialty areas to meet accumulating demand for audit capacity and service improvement, the Musculoskeletal Directorate has now committed to adopt ongoing salary support of the database manager that was initiated solely using academic funding streams.

• Earth functions as an audit tool, capturing outcomes relevant to pathway management and patient care, with data queries able to be run on demand.

Earth allows:

• Easy clinic capacity and demand monitoring e.g. major reconfiguration of the early arthritis service, or the evolving young adult service.
• Audit of effectiveness e.g. treatment response outcomes in the nurse-led DMARD escalation clinic service, or treat-to-target using DAS28/EULAR responses
• Audit of patient safety parameters.

• The department has been able to maximise recruitment of eligible volunteers for clinical trials and registries, providing equitable access to clinical research studies; the site was amongst the top ten recruiters nationally during 2 quarters of 2015 for the EIA HQIP, and a high recruiter to TACERA, APIPPRA, TRAFIC and the BSRBR-AS registry.
• Publishing clinical research has been directly facilitated by Earth and a number of manuscripts have been published by the department since 2012.

Financial Performance and Outcomes

• Earth does not capture cost or resource use data directly. However, the database could be used to help estimate service costs, such as the biologics clinic (including drug costs).
• Academic funding streams provide substantial financial investment for the database manager’s salary over a 30-month period. The database manager and their position within the rheumatology department was critical to the success of Earth.
• Software common to both the trust and university has been used, meaning no significant additional costs have been incurred.
• Comparing costs of the function of Earth with that if Earth did not exist, show it to be cost-neutral day-to-day, but has added value and this does not include commercial study income that has been boosted by Earth.

Patient Focus and Satisfaction

• Earth has been designed with quality service provision, clinical outcomes, and research with direct relevance to patients in mind.
• During the development of Earth, clinicians, research staff and the directorate manager attended a meeting of the active local patient group, which is supported by NRAS, to exchange ideas for its development (including research aspects), and uniformly positive feedback was received.

Our philosophy is that an environment in which research activity becomes seamlessly integrated with service delivery fosters a “virtuous cycle” in which measurable enhancements in evidence-based practice accompany increased patient access to high quality clinical and translational research.

We recognise that, underpinned by research investment, our initiative was able to evolve only in the context of a research-intense environment at a university teaching hospital. However, we believe that our model demonstrates that IT infrastructure development, and a recognition of the value of embedding IT expertise within the NHS at a departmental level, provides a powerful catalyst to creating a culture of this kind, so improving the quality of the patient experience.

This may encourage other trusts and departments (including at district general hospitals) to follow the lead of the Newcastle upon Tyne Hospitals and invest similarly, at a time when complex data management needs within the NHS are set to continue to rise.