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

Helen Cullington, Padraig Kitterick, Mark Weal, Magdalena Margol-Gromada, Helen Cullington, Padraig Kitterick, Mark Weal, Magdalena Margol-Gromada

Abstract

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.

Keywords: cochlear implantation; cochlear implants; hearing; patient-centred care; telemedicine.

Conflict of interest statement

Competing interests: The primary investigator, HC, performed occasional private consultancy work for the cochlear implant company Cochlear Europe. HC reports grants from The Health Foundation during the conduct of the study; other from Cochlear Europe, other from Advanced Bionics, grant from British Society of Audiology, grants from Healthcare Quality Improvement Partnership, other from MED-EL, grants from Oticon Medical, personal fees from Maney publishers, grant from Ida Institute, outside the submitted work. PK reports grants from The Health Foundation and British Society of Audiology during the conduct of this study related to the submitted work; also grant from Cochlear Europe, grant from Phonak, grant from Action on Hearing Loss, grant from National Institute for Health Research, grant from Ida Institute outside the submitted work.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Consolidated Standards of Reporting Trials (CONSORT) flow chart of project participants. BKB, Bamford-Kowal-Bench; HUI3, HUI Mark 3; PAM, Patient Activation Measure; SSQ, Speech, Spatial and Qualities of Hearing Scale; TDT, Triple Digit Test.
Figure 2
Figure 2
Change in Patient Activation Measure (PAM) score from baseline to study exit in control (n=27) and remote care (n=27) groups. Outliers (more than 1.5 box lengths above or below the box) are shown as circles. The numbers by the markers represent individual case identifiers.
Figure 3
Figure 3
Change in Triple Digit Test (TDT) speech reception threshold (SRT; dB) from baseline to exit for control (n=14) and remote care (n=14) groups.

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