Title: Follow-up and structured monitoring for adults offered a NHS hearing aid for the first time (FAMOUS): a cluster randomised controlled trial
Funder: Department of Health and Social Care

Abstract: BACKGROUND _x000D_ Each year in the UK about 355,000 adults are fitted with hearing aids for the first time, costing the NHS £450 million. It is known that hearing aids improve communication and quality of life in adults with hearing loss; nevertheless, we have shown that 30% of those receiving hearing aids do not use them as often as recommended and a further 20% do not use them at all. This is because some adults have difficulty learning to use their hearing aids, which leads to bad habits and non-use._x000D_ The support offered to first-time NHS hearing aid users varies hugely around the UK, which is problematic since patients may not seek help themselves. Because it is known that greater hearing aid use results in more benefit for adults with hearing loss, we have identified four things that audiologists should do to increase the amount of time new users wear their hearing aids:_x000D_ • At assessment: help the patient identify situations in which they have difficulty hearing and where they wear the hearing aids. _x000D_ • At fitting: help the patient plan how to integrate hearing aids into their daily life and provide a diary to record successes and challenges._x000D_ • One week after fitting: fast-track patients with difficulties back to the clinic to resolve the problem._x000D_ • Six weeks after fitting: offer all patients a face-to-face follow-up._x000D_ _x000D_ AIMS_x000D_ We will test whether our four-step support strategy increases the amount of time that new users wear their hearing aids and the impact this has on NHS resources. We will also confirm that greater use has positive impacts on the daily lives of hearing aid users and their families._x000D_ _x000D_ METHODS_x000D_ Thirty-six NHS hearing aid services will be randomly assigned to “current practice” (no change to fitting or follow-up) or the four-step support strategy: all patients seen in the same clinic during the trial period will be followed up in the same way. All patients who are fitted with hearing aids will be contacted at 12 weeks and 12 months after fitting to check usage, experience with the hearing aids and general health. A minimum of 5,850 participants will be recruited. Gift vouchers will be offered to encourage responses, whether or not the individual uses their hearing aids regularly._x000D_ _x000D_ Anonymous data from routine clinic records will be used to see if there is an overall difference between the groups in terms of how often patients report using their hearing aids or attend clinic. Clinic staff will be interviewed to find ways to include the four-step support strategy in normal practice and we will compare the overall costs to find which strategy represents the best value for money for the NHS._x000D_ _x000D_ Adults who initially decline hearing aids will be invited to participate in a separate study of longer term follow-up on hearing aid uptake._x000D_ _x000D_ PATIENT AND PUBLIC INVOLVEMENT_x000D_ Our patient panel has contributed to the design of this research and were supported by:_x000D_ _x000D_ • Action on Hearing Loss (largest UK hearing loss charity)_x000D_ • A service user on the NICE committee that identified and prioritised this research need _x000D_ _x000D_ The panel will guide the research to help ensure the trial engages a range of participants who use their hearing aids well, too little or not at all. _x000D_ _x000D_ DISSEMINATION_x000D_ We will publish our findings in academic journals and professional conferences. Action on Hearing Loss will support the team to share our results with the public and key NHS decision makers.

Lay abstract: RESEARCH QUESTION: Is a 4-step follow-up and monitoring intervention clinically and cost effective for adults offered NHS hearing aids for the first time?_x000D_ _x000D_ BACKGROUND: Hearing loss is the leading cause of years lived with disability in the UK. Hearing aids are effective at improving hearing-related QoL and the NHS is the largest purchaser of these in the world, procuring around 1.2m p.a. with ~355,000 new patients each year. We have identified that: (i) 30% of hearing aids are under-used with a further 20% not used at all, and (ii) follow-up and monitoring regimes vary, are ill-defined, and non-evidence-based._x000D_ _x000D_ AIM: To investigate the clinical and cost effectiveness of a 4-step follow-up and monitoring intervention compared to usual care._x000D_ _x000D_ OBJECTIVE: To determine the effects of the 4-step follow-up and monitoring intervention compared with usual care, on: (i) clinical outcomes, (ii) impact on families, (iii) experiences and acceptability to service users and providers, and (iv) cost to the NHS and benefit to society._x000D_ _x000D_ Our online survey of NHS hearing aid clinics revealed that about 10% of otherwise eligible adults initially decline hearing aids. We will carry out a separate, subsidiary, cluster-randomised trial on these ‘decliners’ comparing the effects of remote annual monitoring versus usual care (no follow-up) on later hearing aid uptake._x000D_ _x000D_ METHODS: The main study is a two-arm, multi-centre, parallel-group cluster randomised controlled trial with an internal pilot. 5850 adults fitted with hearing aids will be recruited from 36 sites. Sites will be randomised (1:1) to either the intervention or usual care. The intervention was developed in collaboration with our PPI panels and is aimed at optimising hearing aid usage. It comprises: (i) encouraging patients to reflect on situations in which hearing is difficult and hearing aids may help; (ii) an individualised action plan to reinforce where and when to use the hearing aids; (iii) monitoring, feedback and problem-solving support within seven days of receiving hearing aids; and (iv) face-to-face follow-up to everyone at six weeks after fitting, as per NICE guidelines, but augmented with a review of action plans and the formation of coping plans if necessary. The primary outcome is self-reported hearing aid use at 12 months after initial fitting. Secondary outcomes include hearing-related and health-related QoL along with impact on others._x000D_ _x000D_ TIMELINES: The 40-month project will commence January 2021: months 1-6 set up and approvals; 7-13 site opening and training; 8-17 participant recruitment; 20-33 primary outcome collection; 34 database lock; and 35-40 analysis and reporting. Stop/go assessment will occur end of month 12. _x000D_ _x000D_ IMPACT AND DISSEMINATION: Our partnership with charities, professional bodies, patients and education providers will ensure participants, public, professionals and NHS decision makers are engaged and informed of the results. The methods section of all publications will report the PPI contribution. Dissemination will be at scientific/professional conferences and integrated into our education and training programmes for audiologists. A process evaluation will create a blueprint for those commissioning/delivering services by setting out the core barriers/enablers and the costs/resources necessary to embed and sustain in practice.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: EAR