Title: Quality-Assured Follow up of quiEscent Neovascular agE-relaTed maculaR dEgeneration by non-medical practitioners: a randomised controlled trial The FENETRE study
Funder: Department of Health and Social Care

Abstract: Neovascular Age-Related Macular Degeneration (nAMD) is a common vision threatening condition affecting mainly patients over the age of 65. Effective treatments exist but require monthly visits to hospital eye clinics for tests and eye injections for a period often of several years. At some point during follow-up the disease becomes inactive in many cases and does not need more injections. The risk of a flare-up is high, however, and patients need to continue to be seen every month for a significant period of time. Hospital-based eye clinics are struggling to cope with current and expected workload for assessing and treating patients with nAMD. Transferring care of these patients to the community closer to home would ease the workload for hospital based clinics and offer a better experience of care to our patients. Previous research showed that non-medical practitioners (optometrists) can be trained to follow-up patients with nAMD when this has become inactive. More research is needed however to show with certainty that providing care for these patients in the community by trained optometrists is safe, well-received by patients and beneficial to the NHS in terms of costs. In this study we will involve 742 patients with nAMD who have reached this inactive phase of the disease. Half of the patients that want to take part will continue to have their follow-up appointments, to make sure their disease is quiet, in the hospital eye clinics as usual. The other half, chosen by chance, will have follow-up visits every month in a community optometrist practice by trained optometrists. The research team will provide the training for community optometrists. The study will seek to show that the community based care is no less safe than hospital-based care. We will also check what is the impact of this different way of offering care on the NHS budget and how the patients and practitioners perceive this. We will involve several hospital eye clinics across the country and several community optometrist practices. We will also hold meetings with patients to discuss their priorities and needs when looking at how to set up the community based eye clinics. During meetings we had with patients in preparation for this research, they felt positively about the possibility to receive care closer to home. Throughout the course of this research we will be consulting our patients on issues arising during the course of the study and will rely on their opinions for interpretation of final results as well as help in preparation of materials to patients, public and practitioners. This research is important because it may show that community based care from non-medical practitioners can be safe and well-received by our patients, removing some of the excessive workload from hospital eye clinics and freeing up more space for patients with active disease to be seen and have treatment. Our patients with inactive disease will be able to be seen in a more convenient way closer to home with less time spent travelling. We will make the results of our research widely available to the NHS, optometry groups and our patients to ensure there is clear understanding of the evidence to support any potential new model of care in the community for our patients with nAMD.

Lay abstract: Research Question: Can non-medical practitioners follow-up patients with quiescent neovascular age-related macular degeneration (nAMD) in the community in a safe and clinically and cost effective way? Background: Age-related Macular Degeneration (AMD) is the most frequent cause of blindness in the UK. (Wong et al). Capacity within hospital-based ophthalmology services for management of neovascular AMD (nAMD) is severely constrained. For many patients with nAMD, the disease will become inactive at some point in the course of their treatment. The 2016 HTA funded ECHOES study showed that there is potential to follow-up patients with Quiescent nAMD (QnAMD) safely and effectively by suitably trained non-medical practitioners (Reeves et al). If safe, integrated and quality assured community care can be developed, this should provide opportunities to make services more accessible and convenient for patients while also easing pressure on hospital eye departments. Primary Objective: To assess safety of non-medical practitioner follow-up of Quiescent neovascular AMD (QnAMD) in the community compared to secondary care eye-clinics in correctly classifying re-activation. Secondary objectives: 1. To assess efficiency (rate of over-referral) of community-based and secondary care QnAMD pathways against a reference standard (expert Reading Centre) 2. To estimate the cost-effectiveness and budget impact of community-based optometry QnAMD pathways against secondary care pathways 3. To assess patient and healthcare practitioner acceptability of community based QnAMD pathways 4. To develop a transferable training program for community delivered QnAMD care by non-medical healthcare practitioners 5. To assess the impact on secondary care services (e.g. utilisation of services, waiting lists, etc) of community based QnAMD pathways 6. To develop and assess quality standards (co-developed with patients) for system and individual performance in community based QnAMD pathways Methods: A prospective randomised multi-site clinical trial will be conducted recruiting 742 patients with QnAMD from secondary care sites. Patients will be randomised to be followed-up monthly for 12 months either in secondary care or in community-based optometry practices. The study will involve a development phase for community optometrist training and a pilot phase with process evaluation to assess feasibility of the recruitment plan. The full trial will involve a health economics analysis and process evaluation. Timelines: 1) Training development and delivery, set-up of pathways: 6 months 2) Internal Pilot: 6 months 3) Patient recruitment from secondary care (18 months) and follow-up in the two pathways (12 months): 30 months 4) Reading Centre analysis, statistical analysis, health economics analysis, process evaluation, report of results: 6 months Anticipated impact and dissemination: This research project will potentially validate in terms of safety, efficiency and cost-effectiveness a model of care for patients with QnAMD by non-medical practitioners in the community. This will be in line with the strategic priorities of the NHS for facilitating access to care for vulnerable patients and bringing care closer to home, while reducing capacity pressures within secondary care. Dissemination will take place through scientific publications and presentations, the ophthalmic charities, NHS commissioning bodies and NHS England.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: EYE