Models of neo-vascular AMD care: ensuring patients are at the centre

Age-related macular degeneration (AMD) is the leading cause of blindness in the UK [1]. There are estimated to be 40,000 new cases of neo-vascular AMD (nAMD or wet AMD) each year in the UK [2]. Almost half of new certifications are for AMD [3]. With the continuing trend towards an aging population, new estimates suggest that the number of people with nAMD in the UK will rise by 59 per cent between 2015 and 2035, from 1.85 per cent among over 50s in 2015 to 2.36 per cent in 2035 [4].

RNIB is hosting a policy roundtable, on 6 April 2017 in Birmingham, in which invited experts consider how the patient perspective can be at the heart of considerations when developing optimal models of nAMD care.

This brief is produced by RNIB resulting from a rapid review of published literature (Appendix 1 describes the methodology used) looking at evidence relating to the patient’s experience of innovative models of nAMD care. It identifies a series of questions to focus discussion during the roundtable. The event is sponsored by Specsavers.

Information from this and four other roundtable discussions will be submitted to the All Party Parliamentary Group on Eye Health and Visual Impairment’s Inquiry into capacity issues in ophthalmology, and collated into a formal report as the final stage.

What services and supports do people with suspected and diagnosed nAMD need?

Rapid developments in treatments that are effective at stopping deterioration in vision, and even reversing symptomsif action is taken quickly[5], mean that patients need to be referred into carequickly if they have suspected nAMD.

After confirmation, follow-up treatments need to happen quickly, beginning within two weeks and then monthly for optimal impact [6]. NICE recommend intravitreal ranibizumab injections, until the neovascular process becomes quiescent or ‘stable’ for at least three months. There is a need for monthly monitoring visits to assess if treatment needs to begin again[7].

Patients often experience anxiety in relation to treatment and injections. Common reasons for apprehension include the thought of having an injection in the eye, fear of losing eyesight and fear of the unknown [8, 9, 10]. ‘An understanding of the experiences of individuals under-going treatment for wet AMD is crucial as it may help guide future strategiesaimed at increasing treatment compliance and minimising the burden imposed on patients’ [8]. Experience of the injection was not as bad as expected [9].

The Royal College of Ophthalmologists’ (RCophth) guidelines for managingAMD patients make specific recommendations including the early provision of verbal and written information about the condition, clear diagnosis; vision prognosis and treatment options [11].Support to come to terms with vision loss can be beneficial. Completion of a Certificate of Visual Impairment (CVI), for those eligible, will link the patient to support in the community. Clinical commissioning guidance states that low vision support, rehabilitation and advice at an early stage of sight loss is ‘imperative’ for those who have significant permanent sight loss [12]. Eye Clinic Liaison Officers (ECLOs) can facilitate all of this beyond the actual treatment [5].

What challenges do patients experience in accessing diagnosis and care?

The main entry point for patients with suspected nAMD is through community optometry. Local protocols will be in place and a UK wide fast track referral form exists to get appointments with a macular specialist. Optometrists may not always make accurate clinical judgements to prompt that referral [13].

As a result of the availability of effective Anti-VEGF treatments, and the need for more regular interventions, numbers of patients needing to be seen byHospital Eye Services(HES) has increased significantly. In 2012, the Action on AMD group [5] noted that although many local services had adapted to this initially:

‘...limited or inadequate clinical capacity continues to threaten optimal care and access to potentially sight-saving treatment for wet AMD patients. Some NHS clinics are failing to maintain recommended follow-up intervals for patients with wet AMD. Delay in follow-up beyond the recommended interval may cause patients to unnecessarily lose vision permanently.’

Many sources confirm that these delays are happening [14,15, 16].Recent surveillance data shows thatup to 22patients per month, with conditions including AMD, are suffering permanent and severe visual loss due to health service initiated delays in follow-ups [17]. The median delay beyond the intended follow-up period was 22 weeks but ranged from two days to five years.

The Action on AMD group described capacity issues (clinic space, staffing, equipment, support and quality and funding) and their consequences, which all have implications for the service that patients receive, including delayed and inferior quality care [5].In their themed review, Healthcare Inspectorate Wales describe nAMD services as ‘fragile’ [16].

Research suggests that the reality of service provision falls short of providing the support and information that patients look for. Although their need for information about treatment varies widely, and should be tailored to the individual[9],generally current provision of written and verbal information doesn’t meet need, so patients don’t know what support is available and lack the knowledge to self-advocate [18, 19].Time spent waiting in the clinic at each appointment added to anxiety [9, 10], whilst time spent with other patients may alleviate anxiety [20].

Reviewing qualitative research, Bennion and colleagues describe how AMD can impact on day to day living; concern around of losing independence and becoming a burden to family can be real fears [21]. They highlight the considerable emotional impact a diagnosis of AMD can have, and unmet need to respond to this [21]. McCloud found that though new treatments have resulted in ‘cautious optimism’ for some, while “profound loss” was a major theme discussed by others in their research [22].In a multi-country survey, though some patients expressed hope and determination,fear,sadness,frustration and depression were more common [23].Many eye clinics across the UK still do not employ an ECLO to provide emotional and practical support. In England,68 of the top 150 health trusts in terms of patient numbers have access to an accredited ECLO; in contrast, all hospitals in Northern Ireland have ECLOs [24].

In addition to a concentration in older people, certain groups are more at risk of AMD (wet and dry combined). Those from low socio-economic groups [25] and from white backgrounds [26]appear to be more susceptible.

What alternative ways of delivering care are in place?

The Way Forward [4] notes that if numbers of people with dry AMD and nAMD rise at the predicted rate ‘this is clearly going to stretch ophthalmic services and the support structures that exist to help those with visual loss. Inaction, therefore, is not an option. Changes to the way we deliver AMD services are inevitable...’ [4]. The following responses to capacity issues have already been implemented (the categories used here borrow from The Way Forward):

1.Virtual Clinics: Use of IT to ‘virtually’ review patient information (visual acuity, OCT and colour photos), outside of face to face interactions has been implemented in over 60 per cent of eye departments surveyed by RCophth[4]. Virtual clinics, where consultants assess all, or a proportion, of patient informationcan be for new referrals, stable patients off treatment, patients transitioning into a clinic run by other health care professionals (HCP) and clinics run in community settings by HCPs. HCPs may include orthoptists, hospital optometrists and ophthalmic nurses.

Referrals sent by email, with images attached, from community optometry may allow ophthalmologists to effectively triage patients [12, 27]. Optometry practices have the potential to operate as spokes, in a hub and spoke model [12].The Action on AMD group [5] recommend community optometristsare involvedin monitoring ‘stable patients’, carrying out OCT tests for virtual review in the HES. A benefitfor patients is thatpractices are usually in locations accessible to them. However,such involvement requires investment in secure, efficient IT connections and OCT equipment.Clinical governance, training and payment structures need to be instigated. Recent thematic inspection in Wales found that exchange of clinical images between sites is not always possible [16].

2.Non-medical injectors:A majority of HES now involve health care professionals in delivering intra-vitreal injections whereas previously this had been restricted to ophthalmologists [4]. Consensus is that whether or not a patient requires injections needs clinician input, but not performing the injection. The Way Forward states ‘the case for non-ophthalmologist injectors has been clearly made, and training and medico-legal considerations explored and an excellent safety profile established’. Schemes in place in Wales have had positive impact, but not all health boards have picked this up, for instance due to a lack of clarity around arrangements for indemnity[16].

3.One-stop clinics: Some clinics are set up to assess, investigate and treat patients at their first visit. In the RCOphth survey 30 per cent of services were taking this ‘one stop’ approach which was seen to work well for older patients, be better for the environment, and reduce indirect costs[4]. This model can be undermined by inappropriate referrals from primary care, which may result from optometrists not having access to OCT or skills to make more accurate judgements [16].An innovative ‘side ways’ referral scheme to an optometry practice in Newport, with an OCT scanner linked to secondary care, was able to deflect over a third of patients away from secondary care in its first weeks of operation [16].

4.Intravitreal injection service management: Rather than being restricted to monthly injecting, alternative approaches to maintenance have been developed. ‘PRN’ has fixed monitoring intervals but the patient receives an injection only if the OCT shows a recurrence of fluid or hemorrhage. ‘Treat and extend’ has the patient receive an injection at every visit, but the gap between visits is stretched to a maximum of 12 weeks, unless there are indications that a return to more frequent treatment is required. ‘Treat and extend’ has been shown to be an effective approach, reducing treatment burden [28].

Other aspects of the service have been adapted including ways of using the physical space, such as partitioning a clinic room to increase numbers of patients who can be seen, and deployment of staff [4]. Mobile units or GP clinics can be alternative locations, which are more convenient for patients, but still require staff, IT connections and monitoring equipment [5].

5.HCP injectors in remote centres, without ophthalmologist present: This arrangement can reflect a desire to take services to people in rural areas or to utilise non-traditional NHS providers as injectors. There is a need to ensure that staff are able to deal with complications that arise [4].

Do patients get the same quality of care from different service models?

There is little published research that evaluates outcomes from new models of service delivery, and especially outcomes for patients. There has been some assessment of virtual clinics and involving community optometry.

Virtual clinics

Kelly carried out service evaluation of the effectiveness of OCT images captured by a community optometrist, sent electronically to the HES for triageand diagnosis and concluded that ‘Teleophthalmology consultation with communityoptometry enables ophthalmologists to focus on macularpatients with significant/urgent disease and, if applied morewidely, could reduce referrals, costs, and waiting times forsuch services in the United Kingdom’ [27].Research in Fife confirmed the electronic transfer reduced referrals for conditions including AMD [29]. Ophthalmologists express concern that virtual clinics may be better suited to more homogenous patients, but they see the efficiencies they create as a counter-balance to this[4].

Involving community optometry

The ECHoES trial [30] compared the decision making of community optometrists and HES ophthalmologists in relation to making retreatment decisions as part of monitoring nAMD. Both sets of professionals had both undertaken an identical training programme,and assessed virtual vignettes of retinal lesions in patients that were previously quiescent. They found that optometrists were as good at classifying lesion status, though tended to be more cautious. Although this comparison is clearly different to decision making in real clinic settings, the context is similar to how virtual clinics are operating.The cost of reviews was similar, but slightly higher for optometrists [31].

Townsend and colleagues involved in the ECHoES trial undertook qualitative research with a range of stakeholders investigating the concept of shared care. The challenge of travelling to HES appointments, for those who live further away from the HES or who are very elderly, and the impersonal nature of the service they receive was linked to enthusiasm among AMD patients for receiving care through their community optometrist [15]. Optometrists were positive about the role that their profession can take in sharing care, believing they are competent to do so. Ophthalmologists were more hesitant, referring to frequent incorrect referrals from optometrists, feeling that the hospital can better support clinical decision making, and that patients would have greater trust in them. Patients with active nAMD said they were willing to wait for care they trusted.There was disagreement about potential cost efficiencies of monitoring by optometrists, any savingsfrom the reduced amount paid to optometry would be counterbalanced by it potentially taking longer for them to make their assessment, cost of equipment and requirement for training input[15].

Ellis [32] and Ghazawy [33] both question whether adding in a referral refinement role with community optometrists who have a special interest simply adds delaybefore the patient is seen by a medical retina specialist. The suggestion of cost savings is disputed as a high proportion of patients still need to be seen by the specialist before treatment can get underway.

In order to begin to understand the quality of activity and outcomes,the Joint Commissioning Guidance from College of Optometrists and the RCOphth (2013) [12] encourages commissioners, providers and other stakeholders to produce an annual quality report for AMD.The National Ophthalmology Database collates pseudonymised data from routine clinical care for purposes including national audit and a feasibility study for nAMD is underway (

What are the ways to ensure patients get the best care?

In 2012, the Action on AMD group made the following recommendations for quality, effectiveness, and productivity, and, therefore, increasing capacity [5]:

  • Appropriate funding and resources must be made available now that treatment is possible.
  • There should no compromise in the standard of service provision, or quality or frequency of intravitreal treatment administration.
  • Continued evaluation and adaption/redesign of local wet AMD NHS service is required.
  • Recruitment. Of additional consultant staff or middle-grade medical staff. Optometrists and senior nurses can be trained to perform assessments.
  • Prioritisation/ stratification of patients.
  • Virtual clinics.
  • Use of other community spaces such as mobile units, polyclinics or GP clinics.
  • Multi-disciplinary clinics-staff training and development, flexible role, and appropriate use of staff.
  • Use of community optometrists for monitoring ‘stable’ patients.
  • Electronic referrals from community optometrists.
  • Electronic medical records
  • Employment of an ECLO.

Published at the start of this year, The Way Forward [4]has revisited Action on AMD’s analysis of limitations to service capacity and advises HES departments to assess their services against them.

Gaps in the evidence

There are significant gaps in the evidence around models of care. These gaps need to be addressed to ensure patients receive the best care.

1.Effectiveness of innovative models: In contrast to Glaucoma services the evidence base for new models of care appears underdeveloped. Key documents [4, 5] present case studies but not evaluations.Reeves notes that many HES’s involve HCPs in clinical decision making without evaluation [30]. Specifically in relation to shared care Townsend and colleagues see a need for pilot studies ‘to work out the practicalities and provide real-life proof of concept’ [15]. We hope that there will be significant learning from evaluations of the four pathfinder pilot services in primary care settings in Wales [16].

2.Cost effectiveness: Cost effectiveness of schemes is important to ensure the best use is made of public resources to enable optimal patient care, however, this does not seem to have been addressed in the published literature (with the exception of the ECHoES trial).

3.Equity of access: Research needs to examine how different models of care impact on equity of access for patients.Do some patients benefit more than others? If so, which? There is little research that explores inequalities in any form within the context of nAMD care.

4.Supporting patients’ attendancefor treatment: Ensuring all models of care provide patients with support to attend and undergo treatment is critical. The published literature does explore how patients approach treatment and respond to diagnosis, but there is little information about the support offered to patients in coping with anxiety around treatment and fear of losing sight in new models of care.

What do we need to know about models of nAMDcare to ensure patients get the best outcomes?

  1. How can patients be better supported through treatment?
  2. What are the anticipated benefits and challenges of delivering AMD services in the community/ primary care settings?
  3. What needs to happen for optimal services to be commissioned?

Authors:

Catherine Dennison, Helen Lee, Puja Joshi and Kate Flynn. RNIB

Appendix 1 Methodology

PJ and KF carried out the searches to identify relevant material published in, and since, 2000, using the search engines PubMed and Science Direct. The following key words were used: AMD, Age-related Macular Degeneration, Wet AMD, Dry AMD, neovascular AMD, neovascular Age-related Macular Degeneration, Service*, Shared Care, Enhanced, Community, Patient*, Diagnos*, Ophthalmology, Optom*, Referral*, Consultation*, Outcome, Evaluation, and Local. Over 80 peer reviewed papers, reports, guidance documents and articles were identified. Reference lists were hand-searched.