Shared learning database

University Hospitals Birmingham NHS Foundation Trust
Published date:
September 2009

The UHBFT Ophthalmology Team in collaboration with the divisional management and with support from the Trust Board, developed a robust service plan in anticipation of the NICE guidance and the first Lucentis® treatments commenced in April 2008 (subject to case by case funding approval from the relevant PCT) well in advance of the actual publication of the NICE guidance.

Systemic, structured and responsive approach to the service development has enabled UHBFT to expand the service from one to four clinics a week and to accommodate the rapidly growing demand.

During 2008/09 the UHBFT Ophthalmology team performed 439 Lucentis® treatments, over 3.5 times more than the originally anticipated 120 cases.

Does the example relate to a general implementation of all NICE guidance?
Does the example relate to a specific implementation of a specific piece of NICE guidance?


Aims and objectives

The UHBFT Ophthalmology team recognised early that the anticipated publication of the NICE guidance in August 08 would have considerable impact on the department. Detailed advance planning for the set up of a Lucentis® service commenced in 2007. A business case was formulated by the clinical team, divisional management and finance, which received full backing of the Trust board prior to the NICE approval of Lucentis®. The main aim of the implementation initiative was to ensure that the UHBFT Ophthalmology department was ready to provide this sight saving treatment in a well planned manner as soon as the NICE guidance was published.

Funding secured as a result of the business case enabled the appointment of a new consultant in medical retina to lead the service, together with a new visual technician responsible for performing the extra imaging needed by the service and a dedicated administrator to coordinate the service. New electronic patient record software was purchased and installed specifically for ARMD, and all the staff involved in the provision of the Lucentis® treatment received appropriate training for the new system.

1) To achieve rapid implementation of NICE guidance in order to meet patient expectations post publication of the guidance
2) To design a flexible and responsive service, able to swiftly adapt to changing referral patterns and increasing demand
3) From the outset, to prospectively record clinical data, electronically, to enable instantaneous and continuous audit of the treatment outcomes.

Reasons for implementing your project

Prior to Lucentis®, photodynamic therapy (PDT) was the only treatment available for subfoveal ARMD lesions. This treatment was restricted by NICE guidelines to classical lesions, which constituted less than 30% of patients with wet ARMD. As a result a considerable cohort of patients with potentially treatable wet ARMD was ineligible for treatment and would end up registered blind. Recent large randomised controlled clinical trials (MARINA, ANCHOR and PIER) had shown unequivocally the efficacy of anti-vascular endothelial growth factor (VEGF) therapy in preventing visual loss in people diagnosed with sub macular wet ARMD. This led to the licensing of the anti-VEGF Lucentis® (ranibizumab). The treatment criteria published by NICE in August 2008 allowed treatment with Lucentis® for almost all lesion types, meaning eligibility is close to 100%.

Treatment with PDT required patients to be followed up every 3 months following the first treatment. With Lucentis®, patients require a loading phase of 3 injections with 4-6 weekly follow up and further injections when required (10 injections on average over the first two years). The Royal College of Ophthalmologists has calculated this represents a 6-9 fold increase in the wet ARMD workload.

The UHBFT Ophthalmology team recognised that in order for the service to be responsive to the above developments and to ensure that patients had access to the most up-to-date treatments, careful service and financial planning was required. A project plan was devised, the main objectives of the project being:
- Easy, equitable access for patients to this vital, sight saving treatment
- Establishment of appropriate infrastructure to support effective and efficient function of the service
- Development of necessary competencies within the Ophthalmology team
- Make the best use of available Information Technology
- Education of referring Optometrists and GPs.

How did you implement the project

1) 1st routine Lucentis® clinic took place at UHBFT on 01st of September 2008 (just three working days after the publication of the final NICE guidance on 27th of August 2008). Structured planning and active anticipation of the impending guidance were the key enablers that allowed the team to 'hit the ground running' and to run an efficient service from day one.

2) No patient waiting longer than one week from the receipt of the referral to the initial assessment. The department consulted with local optometrists and GP practices and set up a direct fast track referral system, whereby a standardised referral letter can be faxed to the ARMD coordinator; this allows direct booking into the ARMD clinic within 1 week. Optometrists are able to refer directly using this system to prevent delays in care pathways. The new retinal consultant was employed on a flexible timetable providing the department with built in capacity to change both the profile and the timings of clinic and theatre sessions. Therefore the service was able to respond to the fluctuations in demand for the new treatment from day one despite limited staffing and space availability within the department.

3) No actively treated patients registered blind. Only 7.8% of blind registrations were due to Wet ARMD in the 12 month period of service and none of these were eligible for treatment with Lucentis® (for comparison, in 2006 23.7% of blind registrations were due to Wet ARMD).

4) Increasing numbers of patients are receiving essential treatment. During the first year the actual activity (439) exceeded the predicted yearly activity (120) more than 3.5 times. Projected activity for 2009/10 is even higher at 600 cases. Low waiting times and established reputation have led to a significant increase in out of area referrals as patients choose to travel to UHBFT in order to benefit from excellent clinical care.

Key findings

All of the data on visual outcomes from treatment can be audited on the electronic patient record (EPR) system in a matter of seconds, so up to date data is available for comparison with the expected outcomes. It also allows the team to track the numbers of injections given, and if and when a patient has received 14 injections to an eye, to get any further injections funded by the drug manufacturer rather than the NHS.

Introduction of the EPR for AMRD patients has eliminated the long standing problem of patients' notes being unavailable on the day (previously ~ 10%); with all previous treatment and consultation records available electronically. It allows the clinical team to instantly track the progress of the patient from day one. The EPR is linked with FFA camera and OCT to provide access to all previous imaging/ investigations in a single format from anywhere within the department. High quality detailed patient information advising patients on how to check their vision correctly has allowed the department to reduce the frequency of planned follow up appointments from every 4 weeks (as recommended in the clinical trials) to monthly (for the duration of 3 months) then bi-monthly (for the duration of 6 months) and finally tri-monthly (for the duration of 12 months) with no evidence of adverse outcomes to date.

The UHBFT Ophthalmology department will be presenting the results of this implementation project at the annual meeting of the Royal College of Ophthalmologists and to the Midlands Ophthalmological Society.

Key learning points

Horizon scanning and planning in anticipation of the guidance were the key drivers at UHBFT that led to the rapid implementation of this guidance. It was important that the lead clinician was identified early in the process to ensure that the implementation was clinically driven with ongoing strong support from the Trust's management team.

Involvement of both internal and external stakeholders at all stages of the project was crucial to its success. The team worked very closely with patients, local Optometrists and GPs, local Primary Care Trust, management, estates, finance and infection control to name but a few.
Careful business planning underpinned the implementation:
- Anticipated patient numbers were calculated from PCT data using the NICE template
- Costs per patient and infrastructure costs were calculated.
- Business modelling was done in advance of publication of the guidance - detailed business planning commenced in January 2008
- Staff, space and equipment requirements were identified
- The business case received strong support from the Trust's executive team and procurement commenced
- Infrastructure was in place prior to the publication of guidance
Ongoing close monitoring of the uptake of the service and clinical outcomes has allowed seamless expansion of the service in response to rapidly increasing demand.

Contact details

Inese Edgcumbe
Group Manager
University Hospitals Birmingham NHS Foundation Trust

Secondary care
Is the example industry-sponsored in any way?