Personalised long-term follow-up of cochlear implant patients using remote care, compared with those on the standard care pathway: study protocol for a feasibility randomised controlled trial

Abstract

Introduction: Many resources are required to provide postoperative care to patients who receive a cochlear implant. The implant service commits to lifetime follow-up. The patient commits to regular adjustment and rehabilitation appointments in the first year and annual follow-up appointments thereafter. Offering remote follow-up may result in more stable hearing, reduced patient travel expense, time and disruption, more empowered patients, greater equality in service delivery and more freedom to optimise the allocation of clinic resources.

Methods and analysis: This will be a two-arm feasibility randomised controlled trial (RCT) involving 60 adults using cochlear implants with at least 6 months device experience in a 6-month clinical trial of remote care. This project will design, implement and evaluate a person-centred long-term follow-up pathway for people using cochlear implants offering a triple approach of remote and self-monitoring, self-adjustment of device and a personalised online support tool for home speech recognition testing, information, self-rehabilitation, advice, equipment training and troubleshooting. The main outcome measure is patient activation. Secondary outcomes are stability and quality of hearing, stability of quality of life, clinic resources, patient and clinician experience, and any adverse events associated with remote care. We will examine the acceptability of remote care to service users and clinicians, the willingness of participants to be randomised, and attrition rates. We will estimate numbers required to plan a fully powered RCT.

Ethics and dissemination: Ethical approval was received from North West-Greater Manchester South Research Ethics Committee (15/NW/0860) and the University of Southampton Research Governance Office (ERGO 15329).

Results: Results will be disseminated in the clinical and scientific communities and also to the patient population via peer-reviewed research publications both online and in print, conference and meeting presentations, posters, newsletter articles, website reports and social media.

Trial registration number: ISRCTN14644286; Pre-results.

Keywords: OTOLARYNGOLOGY.

Figure 1

Flow chart of project. Items in blue apply to all enrolled cochlear implant users, purple: control group only, orange: remote care group only, green: staff. CIRCA, Cochlear Implant Remote Care; HUI, Health Utilities Index; PAM, Patient Activation Measure; SSQ, Speech, Spatial and Qualities of Hearing.