Participation in a national study of adult NHS hearing aid services

Adult NHS hearing aid services are invited to participate in a national study about the effectiveness of monitoring and follow-up of new adult hearing aid users. This article provides background information about the study. If you are interested in finding out more about the study, and potentially your service taking part, you should register your interest by sending an email to FAMOUS@nottingham.ac.uk

Background

In 2018, the National Institute of Health and Care Excellence (NICE) published a national guideline on assessment and management of hearing loss in adults (National Guideline 98; https://www.nice.org.uk/guidance/ng98). The guideline addresses uncertainties and variations in clinical practice.

One topic addressed in the guideline is the effectiveness of follow-up and monitoring for new adult hearing aid users. A review of the literature failed to identify any evidence on the topic. The conclusion from NICE was that current practice varies, is ill-defined and is non-evidence based.

As a result of this finding, the government, via the National Institute for Health Research Health Technology Assessment programme (NIHR131159), commissioned and recently funded, a national project to address this gap-in-knowledge. The project, due to start later this year, is known as the FAMOUS study, short for ‘Follow-up And Monitoring Of new USers of NHS hearing aids.

This is an opportunity for NHS audiology services to work collaboratively to provide an evidence-base for clinical practice. The scale and scope of FAMOUS is unparalleled in UK audiology. It will involve the recruitment of a total of around 3,600 new adult hearing aid users across as many as 40 audiology services, and requires no previous experience in clinical research.

Who will conduct the study?

This is a national study and involves a collaboration between the Biomedical Research Centres in Manchester, Nottingham and UCLH. A national study of this size involves a large number of investigators and collaborators, and a full list of those currently involved is provided at the end of this article.

Are you interested in becoming involved?

We are looking for around 40 NHS audiology services to become research sites in the FAMOUS study. The trial will compare the effectiveness of two models of follow-up and monitoring. One model is standard/usual care as currently provided by individual services (we recognise this will vary from service to service). The second model to be delivered at the other half of the sites is based on the best possible evidence and is referred to as ‘standard care plus’. The outcome measures that will be used to determine the effectiveness of the two models will be collected by the FAMOUS research team at 12 weeks and 12 months after fitting. Your service will not have to gather these data.

What would you have to do?

FAMOUS is a cluster randomised trial, meaning that sites (i.e. services) and not individual patients will be randomised. As such, each site will be randomised to either continuing your current standard care, or ‘standard care plus’ to all patients. For your adult hearing aid service to take part in the study, you would need to:

1.   Agree to be randomly assigned to either standard care or standard care plus.

2.   Identify potential participants for 12 weeks. This doesn’t involve taking consent but you will asked to provide all patients seen over this period with a patient information sheet explaining the study.

3.   You will provide the same care to ALL first-time adult hearing aid patients who pass through your service during this 12 week period.

4.   Send patients a questionnaire with a follow-up telephone call, at 12 weeks and 12 months. The patients will complete and return the questionnaire direct to the FAMOUS research team. You will also need to share some routinely collected data (de-identified) from clinical records with the FAMOUS research team. These tasks do not need to be undertaken by clinical staff.

What is involved in standard care plus?

Standard care plus has four components that are specified in the trial design and may take a little extra time:

a.    At the assessment appointment, identify listening situations where hearing loss is causing difficulties;

b.    At the fitting appointment, develop an individualised plan to reinforce where and when to use the hearing aids;

c.    Provide monitoring, feedback and problem-solving support during the first week of hearing aid use, so that support can be provided before bad habits and poor use sets in; and

d.    Augment the 6-week follow-up with a review of the individual plan and, if necessary, provide coping strategies.

What has been done to help busy NHS services become partners in this national study?

To facilitate participation in the study, we have kept the patient identification window to 12 weeks. It is only new adult hearing aid referrals who are being seen for hearing assessment during this one-off 12-week period who will take part. Starting dates will be staggered across NHS services, with the first service commencing around January 2022. Also, to make this as uncomplicated as possible, the same model of care will be provided to every adult in your individual services: either your usual care or ‘standard care plus’.

Does your department need prior experience in conducting clinical research?

We understand that NHS departments are busy. We also appreciate that not everyone will have had the opportunity to be involved in research previously. As long as you are motivated and enthusiastic to run the study for 12 weeks, the FAMOUS team will provide all the support you need.

What support will you receive if you agree to take part?

The trial is being coordinated by the Nottingham Clinical Trials Unit (NCTU) at the University of Nottingham. NCTU has experience of conducting trials in adult audiology services, and has a unique understanding of the challenges your service may face, and the support you will need to run the trial. The trial will be supported by dedicated NCTU staff who will help guide you through the site set-up process and will offer general research and trial-specific training before you start recruiting, and a refresher training, as needed, throughout the course of the trial. There will always be an NCTU member of staff available to email or call if you have any questions, at any stage of the trial.

Why should you take part?

This is a great opportunity to be a part of clinical research, whilst being fully supported to do so. It addresses an issue at the heart of adult rehabilitation services and directly related to your day to day practice. The findings from this research will inform national guidance and provide important evidence to support and shape service delivery. For each service that takes part, there is also an opportunity for one clinician to take a lead research role, that of ‘Principal Investigator’. There is good evidence that health outcomes are improved in services that are active in research, and there has previously been a lack of opportunities for research in audiology compared to other NHS services.

What effect will the COVID-19 pandemic have on the study?

We are aware that services are under pressure, many with a reduced number of appointments and an increase in remote care. We are keeping this under review and will modify the project if required.

What should you do next?

If your service is interested in participating in FAMOUS, send an email to FAMOUS@nottingham.ac.uk and we will send you further information.

Kevin J Munro, Jane Wild and Rachel Haines, on behalf of the FAMOUS team and BRC partners

FAMOUS@nottingham.ac.uk

Acknowledgements

The FAMOUS trail is funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme (NIHR 131159). The views expressed are those of the research team and not necessarily those of the NIHR or the Department of Health.

List of investigators and collaborators

·         Lead Investigator: Kevin Munro

·         Co-Investigators: Chris Armitage, David Baguley, Rachel Elliott, Rachel Haines, Ted Leverton, Alan Montgomery, Francesca Oliver, Chris Partlett, Caroline Rick, Anne Schilder, Jane Wild, Paul Wilson.

·         Collaborators: Piers Dawes, Harvey Dillon, Gaby Saunders, Padraig Kitterick, Graham Naylor, Mel Ferguson, Nish Mehta