Clinical trial NCT05154539: Innovation of Hearing Rehabilitation and Effects of Reform
Official title: Innovation of Hearing Rehabilitation and Effects of Reform
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2021-12-13
Enrollment: 751
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1:1 three arm randomized, controlled trial.
Primary purpose: SCREENING

Brief summary: The Danish health care system has been criticized for its structural inefficiency and latency to initiate proper hearing rehabilitation amongst hearing-impaired individuals. Waiting lists are extensive, and audiometries are repeated before hearing aid treatment is initiated. Demographic changes forecast increasing numbers of +65-year-olds and consequently increased demand for hearing rehabilitation. To remedy this situation, the Danish Ministry of Health has proposed a new national initiative to implement innovative digital approaches to improve hearing rehabilitation, including a new, digital remote assessment routine.

The aim of this study is to investigate:

Primarily:

1. Patient safety of remote vs. conventional assessment
2. Patient-reported satisfaction and treatment effect of remote vs. conventional assessment

   Secondarily:
3. Inter-subspecialty and inter-personal assessment differences between four ENT specialists using a remote assessment routine
4. Translation and validation of the Danish adapted version of the Consumer Ear Disease Risk Assessment (CEDRA) questionnaire.

The main study is a randomized clinical trial with three arms and 1:1:1 assignment comprising 751 potential first-time adult hearing aid users.

Since March 2021, 751 patients have been randomized and assigned to 20 different clinics. The remote assessment routine works well for both patients, assessors, and clinics. Inclusion is expected to end in December 2021 and overall study completion is anticipated in april 2022.

Deficient diagnosis of complicating conditions in first time hearing aid users is the main concern in remote assessment. If the study shows the practice to be safe, it could form the foundation of a future nationwide implementation of remote care in Danish hearing rehabilitation.

Detailed description: InHEAR is a prospective randomized controlled trial aimed to investigate a new, Danish digital remote assessment routine applied in 751 hearing-impaired adults. The existing, traditional Danish referral model requires a physical consultation with an ear-nose- and throat (ENT) specialist prior to treatment initiation. The digital referral reform replaces the traditional physical ENT specialist assessment with a standardized examination package performed by educated and experienced audiology assistants, allowing physicians to assess and refer hearing-impaired adults to the relevant treatment regime remotely and asynchronously without meeting the patients physically.

After inclusion, the participants will be randomized equally into three groups:

Test group 1 (TG1) will be testing the digital assessment routine in private hearing clinics.

Test group 2 (TG2) will be testing the digital assessment routine in public hearing clinics.

Control group 3 (CG3) will be assessed in accordance with current Danish practice.

The examination package performed on test group participants comprises of:

1. A standardized, focused medical hearing history record (questionnaire)
2. A standard audiometry test, including air conduction, bone conduction, speech discrimination test and acoustic reflex test
3. Tympanometry
4. Still images of the eardrums performed by video-otoscopy

Four ENT-specialists, two audiologists and to private ENT specialist, will independently and remotely assess the standardized test group examination packages and refer the test group participants to relevant treatment. Participants in the control group are assessed by a private ENT specialist at a physical consultation and referred to relevant treatment in accordance with current Danish practice. Participants with simple hearing loss will be offered hearing rehabilitation with hearing aids. Participants with complicated hearing loss or complicated ear related diseases will be offered a physical ENT specialist assessment at the Department of Audiology at Aalborg University Hospital prior to treatment initiation.

Patient-reported data concerning treatment satisfaction-, quality- and effect will be registered throughout the study period.

Two-three months after treatment initiation, all participants are evaluated by an ENT specialist in Audiology or Otology at a "golden standard" physical consultation at the Department of Audiology at Aalborg University Hospital. Assessment and referral accuracy, patient-reported treatment quality and satisfaction between the test groups and the control group participants will be compared.

Eligibility criteria: Inclusion Criteria:

* Subjective hearing difficulty
* Must be able to understand and read Danish

Exclusion Criteria:

* Recent ENT specialist assessment
* Prior HA usage

Primary outcomes:
measure: Diagnosis of complicating hearing and/or ear-related conditions in hearing impaired adults
timeFrame: Baseline
measure: Remote ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
timeFrame: Month 3
measure: Conventional, physical ENT specialist assessment: Diagnostic accuracy of severe/complicated hearing loss and/or complicating ear-related conditions in hearing impaired adults.
timeFrame: Month 3
measure: Remote vs. physical ENT assessment on correct diagnosis of severe/complicated hearing loss and/or complicating ear-related conditions.
timeFrame: Month 3
Secondary outcomes:
measure: Patient-reported treatment effect
timeFrame: Month 3
measure: Effect of hearing aid treatment
timeFrame: Month 3
measure: Patient-reported satisfaction
timeFrame: Month 1
measure: Patient-reported satisfaction
timeFrame: Month 2
measure: Patient-reported satisfaction
timeFrame: Month 3
measure: HA usage time
timeFrame: Month 3
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Department of Otorhinolaryngology and Audiology, Aalborg University Hospital
Study officials:
affiliation: Department of Otorhinolaryngology and Audiology, Aalborg University Hospital, Denmark
name: Morten Hoegsbro, MD, PhD, MSc
role: STUDY_DIRECTOR
References: