Do you care for adults with moderate to severe, severe, or profound hearing loss in the UK? If so, the COACH trial needs you!
NICE guidance TA566 (2019) expanded access to cochlear implantation for adults in 2019. However, there remains concern that adults without access to cochlear implants can still struggle with acoustic hearing aids. There is not enough evidence to know whether acoustic hearing aids or cochlear implants would be better for adults who fall just outside TA566. COACH aims to generate such evidence.
We are open now and actively recruiting. COACH is a unique opportunity to produce evidence to support NICE guidance change if needed, and influence cochlear implant candidacy guidance internationally.
Any audiologist, ENT surgeon, or other professional involved with hearing care can give their hearing aid users information about the COACH trial. You would not be expected to have in-depth discussions about the trial, as these should only be had with a trained member of staff at a COACH recruiting site or member of the Nottingham Clinical Trials Unit. You can explain to potential participants that if they complete an expression of interest form, their in-depth questions will be answered by experts in the trial.
We are looking for adults with moderate-to-severe, severe, or profound sensorineural hearing loss using one or two acoustic hearing aids. They may or may not have been referred for cochlear implant eligibility assessment in the past.
Please publicise COACH to people with these characteristics:
Your NHS Trust could become a COACH participant identification centre (PIC), meaning it would be reimbursed for your time spent looking for potential participants. If a PIC site uses Auditbase, we provide a custom Crystal report, and training on how to use this, to help identify adults with the correct pure tone audiometry results.
However, your department does not need to be a PIC site to promote the COACH Trial. Here are other ways you can help:
Remember, you are not committing your patients to anything by promoting COACH, just providing them with an opportunity to find out more.
Options include:
Then they can read all the information, watch the videos, and complete an expression of interest form via the website if they are interested to find out more.
They are not committed to going any further in the trial just by completing the expression of interest form.
Once they have completed an expression of interest form, they will be approached by their preferred recruitment site who will carry out pre-screening. If they pass pre-screening, they will be offered a consent visit to make sure they understand the trial and meet our other eligibility criteria.
Eligible adults would then be able to choose whether to proceed further in the trial.
This study/project is sponsored by the University of Nottingham and co-ordinated by Nottingham Clinical Trials Unit.
COACH is an NIHR portfolio adopted, registered clinical trial, sponsored by the University of Nottingham. ISRCTN 15352106. IRAS project ID 297574.