Half of all NHS hearing aids are either under-used or not used at all, and this trial tests whether structured follow-up can change that. Hearing loss is the leading cause of years lived with disability in the UK. The NHS fits around 355,000 new patients each year, yet follow-up care varies wildly and lacks evidence. The researchers have developed a four-step intervention: encouraging patients to reflect on difficult hearing situations, creating an individualised action plan, providing problem-solving support within seven days of fitting, and adding a face-to-face review at six weeks. The main trial will recruit 5,850 adults from 36 NHS sites, randomly assigning clinics to either the intervention or usual care. A separate subsidiary trial will test whether remote annual monitoring encourages the 10% of people who initially decline hearing aids to take them up later. If the intervention works, it could boost hearing aid use without requiring new technology or major expense—just better-structured NHS follow-up. That would improve quality of life for hundreds of thousands of patients and reduce waste of the 1.2 million hearing aids the NHS buys each year. The trial also includes a process evaluation to produce a practical blueprint for NHS commissioners on costs and barriers to implementation.
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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? 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. AIM: To investigate the clinical and cost effectiveness of a 4-step follow-up and monitoring intervention compared to usual care. 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. 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. 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. 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. 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.
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