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

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.

SUBMITTER: Cullington H

PROVIDER: S-EPMC5914764 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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

Cullington Helen H Kitterick Padraig P Weal Mark M Margol-Gromada Magdalena M

BMJ open 20180420 4

<h4>Introduction</h4>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.<h4>Objectives</h4>To assess the feasibility of comparing a remote care pathway with the standard pathway in adults using cochlear implants.<h4>Design</h4>T ...[more]

PMID: 29678970

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Project description:BackgroundImproving retention within randomised controlled trials is important. The effectiveness of different strategies can be assessed using a Study Within A Trial (SWAT). Previous research has shown personalised text message reminders improve clinic attendance rates; however, the results are mixed on improving postal questionnaire return. This SWAT aims to assess whether personalised text message reminders improve completion rates for scheduled telephone follow-ups.MethodsThis SWAT is a two-arm, multi-centre randomised controlled trial with equal allocation. The host trial was the Melatonin for Anxiety prior to General anaesthesia In Children trial (ISRCTN 18296119), where the child's caregiver was to answer a scheduled telephone follow-up 14 days post-surgery; participants for the SWAT were therefore the caregiver. Text messages were sent 24-48 h before the scheduled call and the personalised version contained the first name of the caregiver which was omitted in the non-personalised version. The primary outcome was questionnaire completion rate, defined as the proportion of caregivers successfully contacted, and completed any of the questionnaires, over the telephone within the follow-up window (day 14 + 7 days).ResultsThe SWAT included 100 of the 110 (91%) participants randomised into the host trial. Randomisation within the SWAT was equal between non-personalised (n = 50) and personalised (n = 50) interventions. The overall questionnaire response rate was 73% with a difference between the two interventions of 68% in the non-personalised text message arm and 78% in the personalised text message arm. The adjusted absolute risk difference was 7.1% (95% confidence interval = -10.2%, 24.4%). There was no difference in either the time to response or the number of contact attempts between the two interventions.ConclusionsThere is some evidence that personalised text messages could be effective at increasing response rates when data is collected via telephone and in a population of caregivers for paediatric trial participants. However, similar SWATs have shown mixed results. Given the low-cost and low risks associated with personalising text message reminders, this SWAT could be implemented easily in other RCTs scheduling telephone follow-up appointments.Trial registrationISRCTN 18296119 , SWAT 35 (MRC Northern Ireland Network for Trials Methodology Network).

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

Publications

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

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