ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12619000286145

Ethics application status

Approved

Date submitted

14/02/2019

Date registered

25/02/2019

Date last updated

25/02/2019

Date data sharing statement initially provided

25/02/2019

Date results provided

25/02/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

Teleaudiology hearing aid fitting follow-up consultations for adults

Scientific title

Teleaudiology hearing aid fitting follow-up consultations for adults: an evaluation of a translational study through a single-blinded randomized controlled trial and mini-cohort

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Hearing impairment

Condition category

Condition code

Ear

Deafness

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Description of interventions below are following the TIDieR checklist as recommended.
1. Brief name: Standard face-to-face and teleaudiology (remote) hearing aid fitting follow-up consultations were delivered for adults (new and experienced hearing aid users)
2. Why: Hearing loss is the fourth leading cause of years lived with disability. There is currently over 466 million people with disabling hearing loss across the globe. This number is expected to double by 2050. One of the main barriers to deliver timely services to these people is related to the imbalance between supply and demand in terms of number of patients versus hearing professionals, and their disproportional geographical distribution. The physical as well as economic barriers make difficult for patients to reach a clinic. Consultations at a distance (teleaudiology) would help to improve access to hearing services and reduce the global burden of unaddressed hearing loss. Rehabilitation with hearing aids fitting is the primary intervention for disabling hearing loss. Follow-up hearing aid fitting consultations are the most demading and necessary type of appointment after hearing aid fitting due to the complexity of adjusting the hearing aids to the patients' individual needs and ensure the delivery of the optimum benefit, satisfaction and handicap reduction for patients, which can reflect on their quality of life.
3. Materials: Two laptop computers with Microsoft Windows 10 operating system and two ‘dongles’ to provide 4G mobile internet connectivity were used for remote consultations. Both laptops had the same configurations and replicated the standard audiology computer system including software packages: (a) Noah (HIMSA, Copenhagen, Denmark) with Phonak and Unitron fitting software (Sonova Group, Stäfa, Switzerland) to programme hearing aids, and (b) TeamViewer Business (Goppingen, Germany) to enable the facilitator’s laptop to be controlled by the audiologist’s laptop and video-conferencing between the two sites. A portable bluetooth speaker on the remote site was used to provide better sound than the laptop speaker, and the audiologist used a headset. The laptops microphones used. The facilitator assisting the audiologist and patient on the remote site was also equipped with hearing aid accessories (e.g. otoscope, domes, cerustops, magnets, rotary tool for drilling and griding, cleaning kit, receivers, slim tubes, etc.), and paper copies of the study surveys that needed to be applied straight after the consultation.
4. Procedures: Participants received the fitting of hearing aids in the clinic as standard routine practice. Their care was continued as part of this study by another audiologist. The consistency of the clinical procedures were maintained in both teleaudiology and conventional follow-up consultations in which interventions were focused on the needs of each patient (patient-centred service). After greeting the patient, the audiologist (i) enquired whether there was any improvement in communication difficulties reported prior HA fitting, (ii) identified and/or assessed fitting issues or needs related to physical comfort, sound parameters or ease of management, (iii) addressed the (new) issues (if any) that patient could have been experiencing (e.g. “echoey” speech sound) and/or the audiologist could have identified (e.g. difficulty in correctly positioning the ear piece in the ear canal) through fine-tuning, counselling (including communication strategies) and instructions (including demonstrations and testing, e.g. phone use), (iv) addressed any further questions or doubts the participant and/or his/her significant other person had, (v) informed the patient on what the next step was and what he/she or the audiologist would expect for the next period until the next appointment, and (vi) made sure that all was clear for the patient, that they were happy with apparent result, and then finalized the consultation.
5. Who provided: All the follow-up consultations were provided by the same certified and licensed audiologist with 15 years of clinical experience to control for clinican's expertise. The remote consultations were delivered with the assistance of a facilitator who acted as the audiologist's hands on the remote side to help the audiologist and the patient. To control for the level of experience in assisting the audiologist and patient during the remote consultations, four volunteers in the first year of a Masters in Audiology course, who had basic HAs knowledge but as yet no practical experience acted as the facilitators. Prior to the start of the study, they received face-to-face training on the technical and clinical tasks that they would be required to undertake.
6. How, and 7. where: Two groups with participants randomized for their experience with hearing aids were recruited. Participants in each group received one standard face-to-face and one teleaudiology follow-up consultation in opposite order for first and second consultation. Group 1 (G1) received their first follow-up consultation face-to-face and their second consultation remotely. Group 2 (G2) received their follow-up consultations in the other order, first remotely and secondly face-to-face. Face-to-face consultations were delivered at the clinic as per conventional practice and remote consultations were delivered at the participants' most convenient places (e.g. home, office, clinic) through synchronous (real time video-conference) teleaudiology. The audiologist remotely controlled the fitting software installed in the remote computer and the hearing aids were wiressly programmed through the use of a wireless programming interface (iCube II or Noahlink). During remote consultations, if on occasions the internet connection or transmission of data was poor such that it compromised the communication, a telephone call using the speaker-phone facility was used. Each participant was seen three times by the research audiologist: two follow-up consultations and a third consultation for assessment of outcomes. Service was provided for participants who needed further intervention at this final consultation after the end of the study.
8. When and how much: The study was controlled for the number of interventions. Two follow-up consultations were delivered for each participant and participants did not receive any extra consutlations or any other clinical assistance between consultations, at the clinic in-person or by phone or email, during the study. In addition, the intervals between consultations were controlled through coordination of the availability of participants, facilitators and audiologist, as well as re-bookings resulting from unexpected issues (e.g. sickness), to ensure that intervals were in most cases between 7 to 14 days and thereby, reflecting as closely as possible standard clinical practice for the timing of follow-up consultations. The duration of the consultations was registered and was supposed to be delivered within approximately 45 minutes as per normal clinic routine.
9. and 10. Tailoring and modifications: This study presents a methodology that was incorporated into routine clinical practice of three audiology clinics (Lions Hearing Clinics) in southern, eastern and northern urbans area of Perth, Western Australia. There was minimal disruption to routine clinical practice in relation to the bookings and occasional re-bookings of appointments for the study. Consultations only differed from each other on the mode of delivery. All the clinical procedures (physical and sensory management, instructions and counselling) involved in the HA fitting and follow-up consultations were delivered as they are normally in conventional clinical routine.Ear impressions and real ear measurements (REMs) were not performed in the follow-up consultations due to the need of expensive equipment to be on the remote side and because it is rarely used in follow-up hearing aid fitting consultations. Hearing aid adjustments were based on the REM traces resulted from the fitting consultation and on the fitting needs reported by the participants or identified by the audiologist. Clinical best practices were required to be followed in the clinics from where the participants were recruited and these continued in the care provided as part of this study, as described in the procedures above.
11. and 12. The outcome assessor was the audiologist as it usually is in routine practice. The audiologist who delivered the follow-up consultations made use of a checklist regarding the application of the tools for each participant’s face-to-face and remote consultations for consistency of clinical and research procedures.

Intervention code [1]

Rehabilitation

Comparator / control treatment

The control was a group of participants who received gold standard consultations (face-to-face) and the experimental was a group of participants who received teleaudiology consultations (remote).

Control group

Active

Outcomes

Primary outcome [1]

Primary outcome 1: mean/median COSI score (Client Oriented Scale of Improvement, a validated tool with Likert scale 5 point) by measurement of improvement (change) of communication with interventions.

Timepoint [1]

Identification of communication situations (goals) at the hearing aid fitting consultation and measurements were immediately prior interventions in each of the next consultations (two follow-up consultations and one outcome assessment consultation).

Primary outcome [2]

Primary Outcome 2: mean/median HAII score (Hearing Aid Issues Instrument, a designed tool in absence of an available tool; Likert scale 7 point) by measurement of improvement (change) of fitting issues with interventions.

Timepoint [2]

Identification of fitting issues was done immediately prior the first follow-up consultation and addressed during this consultation. Measurements were at immediately prior each next intervention (in the next consultation).

Primary outcome [3]

Primary Outcome 3: mean/median IOI-HA score (International Outcome Inventory for Hearing Aids, a validated tool with Likert scale 5 point) by measurement of improvement (changes) of quality of life aspects and overall quality of life.

Timepoint [3]

As per original tool, items were applied at the end of the study (Outcome assessment consultation). Some of the items were slightly changed to allow investigation of before-after comparisons.

Secondary outcome [1]

Participants' satisfaction with each consultation was measured by the HASS-P (Hearing aid Service Satisfaction for Patients/Participants) using a 5 point Likert scale. This tool was designed for the study in absence of an available tool. Mean/median scores were evaluated.

Timepoint [1]

The HASS-P was applied straight after the consultations.

Secondary outcome [2]

Participants' satisfaction regarding the service received was measured by the HAUQ (Hearing Aid Users Questionnaire, a validated tool) items #6 and 7 using a 5 pont Likert scale, and items #9 to 11 using open-ended questions.

Timepoint [2]

Applied at the end of the study in the Outcome assessment consultation.

Secondary outcome [3]

Audiologist' satisfaction with each consultation was measured by HASS-A (Hearing Aid Service Satisfaction for Audiologists) using a 5 point Likert scale. This tool was designed for the study in absence of an available tool. Mean/median scores were evaluated. It was used to investigate the quality of the service provided from professional's perspective and also barriers (technical and human-related) to satisfaction with the services provided.

Timepoint [3]

The HASS-A was applied straight after the consultations.

Secondary outcome [4]

Yes/No single question was applied to investigate whether the participants believed that remote consultations can similarly address their needs compared to face-to-face consultations.

Timepoint [4]