Innovation of Hearing Rehabilitation and Effects of Reform

NCT ID: NCT05154539

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 751 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-16
• Study Completion Date: 2022-06-01

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.

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Test Group 1 (TG1)

TG1 participants are testing the new digital assessment routine in a private setting.

Audiology assistants in private hearing clinics located in the Region of Northern Jutland in Denmark are performing the standardized examination packages. The private hearing clinics also conduct hearing aid treatment for TG1 participants with simple hearing loss.

TG21 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation.

Group Type: EXPERIMENTAL

Remote digital assessment

Intervention Type: DIAGNOSTIC_TEST

Remote digital assessment of test group participants

Test Group 2 (TG2)

TG2 participants are testing the new digital assessment routine in a public setting.

Audiology assistants in public hearing clinics located in the Region of Northern Jutland in Denmark are performing the standardized examination packages. The public hearing clinics also conduct hearing aid treatment for TG2 participants with simple hearing loss.

TG2 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation.

Group Type: EXPERIMENTAL

Remote digital assessment

Intervention Type: DIAGNOSTIC_TEST

Remote digital assessment of test group participants

Control Group 3 (CG3)

CG3 participants will be assessed conventionally by a private practicing ENT specialist in the Region of Northern Jutland in Denmark at physical consultation in accordance with current Danish practice. CG3 participants with simple hearing loss can choose whether hearing aid treatment should be conducted in either a private or a public hearing clinic.

CG3 participants with complicated hearing loss or ear-related diseases are referred to the Department of Audiology at Aalborg University Hospital for further examination prior to treatment initiation.

Group Type: ACTIVE_COMPARATOR

Conventional physical assessment

Intervention Type: DIAGNOSTIC_TEST

Conventional physical assessment of control group participants

Interventions

Remote digital assessment

Remote digital assessment of test group participants

Intervention Type: DIAGNOSTIC_TEST

Conventional physical assessment

Conventional physical assessment of control group participants

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Recent ENT specialist assessment
• Prior HA usage

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lene Dahl Siggaard

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Morten Hoegsbro, MD, PhD, MSc

Role: STUDY_DIRECTOR

Department of Otorhinolaryngology and Audiology, Aalborg University Hospital, Denmark

Locations

Department of Otorhinolaryngology and Audiology, Aalborg University Hospital

Aalborg, , Denmark

Countries

Denmark

References

Siggaard LD, Jacobsen H, Hougaard DD, Hogsbro M. Digital vs. physical ear-nose-and-throat specialist assessment screening for complicated hearing loss and serious ear disorders in hearing-impaired adults prior to hearing aid treatment: a randomized controlled trial. Front Digit Health. 2023 Jun 8;5:1182421. doi: 10.3389/fdgth.2023.1182421. eCollection 2023.

Reference Type: DERIVED

PMID: 37363275 (View on PubMed)

Other Identifiers

InHEAR

Identifier Type: -

Identifier Source: org_study_id