Feasibility of personalised remote long-term follow-up of people with cochlear implants: a randomised controlled trial.

INTRODUCTION: Substantial resources are required to provide lifelong postoperative care to people with cochlear implants. Most patients visit the clinic annually. We introduced a person-centred remote follow-up pathway, giving patients telemedicine tools to use at home so they would only visit the centre when intervention was required. OBJECTIVES: To assess the feasibility of comparing a remote care pathway with the standard pathway in adults using cochlear implants. DESIGN: Two-arm randomised controlled trial. Randomisation used a minimisation approach, controlling for potential confounding factors. Participant blinding was not possible, but baseline measures occurred before allocation. SETTING: University of Southampton Auditory Implant Service: provider of National Health Service care. PARTICIPANTS: 60 adults who had used cochlear implants for at least 6 months. INTERVENTIONS: Control group (n=30) followed usual care pathway.Remote care group (n=30) received care remotely for 6 months incorporating: home hearing in noise test, online support tool and self-adjustment of device (only 10 had compatible equipment). MAIN OUTCOME MEASURES: Primary: change in patient activation; measured using the Patient Activation Measure.Secondary: change in hearing and quality of life; qualitative feedback from patients and clinicians. RESULTS: One participant in the remote care group dropped out. The remote care group showed a greater increase in patient activation than the control group. Changes in hearing differed between the groups. The remote care group improved on the Triple Digit Test hearing test; the control group perceived their hearing was worse on the Speech, Spatial and Qualities of Hearing Scale questionnaire. Quality of life remained unchanged in both groups. Patients and clinicians were generally positive about remote care tools and wanted to continue. CONCLUSIONS: Adults with cochlear implants were willing to be randomised and complied with the protocol. Personalised remote care for long-term follow-up is feasible and acceptable, leading to more empowered patients. TRIAL REGISTRATION NUMBER: ISRCTN14644286.

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.

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.