Randomised controlled trial to assess the efficiency and effectiveness of remote care compared with in-clinic care for adult cochlear implant recipients in the first 12 months after activation: a protocol of the INSPIRE study.

INTRODUCTION: Post-surgical care following cochlear implantation is a pivotal part of the rehabilitation journey for cochlear implant (CI) recipients. However, frequent in-clinic visits, particularly in the first year following CI activation, can place a significant burden on CI recipients. Moreover, the growing number of CI recipients may pose a challenge for CI clinics to provide consistent and lifelong care. Cochlear Remote Care is a platform that enables the delivery of post-surgical care through remote hearing assessments and remote video appointments, offering an opportunity to enhance clinic efficiency, eliminate geographical barriers, reduce financial burdens and provide flexible post-surgical options. The primary objective of this study is to compare self-reported hearing ability in daily life among CI recipients who receive post-surgical care through Remote Care with those receiving routine in-clinic care during the first year following CI activation. Additionally, the study will assess the time and costs associated with these care models for both the clinic and patients. METHODS AND ANALYSIS: This multi-centre randomised controlled trial is set to be conducted across 11 clinics in the United Kingdom, Italy, the Netherlands, Belgium and Australia, with an anticipated sample size of 148 participants. All participants will be adults with post-lingual deafness and unilateral CIs. Following baseline measurements at 3 months post-activation, participants will be randomly assigned to either in-clinic visits or Remote Care appointments. At six and 12 months after activation, participants will complete a comprehensive battery of audiometric tests and questionnaires on patient-reported outcomes, usability and resource utilisation. ETHICS AND DISSEMINATION: Ethics approval has been obtained for each clinical site. Study findings will be disseminated widely through peer-reviewed publications, lay language summaries and conference presentations. TRIAL REGISTRATION NUMBER: NCT05552118.