Awareness Among Hearing Enhancement Interventions and Reimbursement Criteria of Hearing Implants

How Well Informed is a Otorhynolaryngologist in a Secondary Setting About the Hearing Enhancement Interventions and Reimbursement Criteria Related to Hearing Implants?

The following research questions will be investigated:

What is the knowledge of medical interventions for moderate to severe hearing loss and what is the knowledge of the reimbursement criteria for hearing implants of otorhinolaryngologists in a secondary setting in Brabant. This will be evaluated by means of a specific questionnaire that will be systematically gone over with the participants during an interview in the first and third phase.

In a second phase, the investigators will investigate how the knowledge of medical interventions for moderate to severe hearing loss and the knowledge of the reimbursement criteria for hearing implants of otorhinolaryngologists in a secondary setting in Brabant can be increased by training the otorhinolaryngologists in a secondary setting in Brabant.

In the third phase, the investigators will evaluate the knowledge of hearing implant interventions and reimbursement criteria among otorhinolaryngologists in a secondary setting.

Study Overview

• Status: Recruiting
• Conditions: Otorhinolaryngologic Surgical Procedures; Implant; Hearing Impairment; Awareness
• Intervention / Treatment: Behavioral: Interview

Detailed Description

In most developed economies, cochlear implants have been shown to be the most successful neuroprostheses for sensory moderate or severe neurosensory loss. These neuroprostheses are cost-effective with low complication rates. However, the literature indicates that there is a low level of awareness of the benefits of cochlear implants among the general population and among healthcare professionals. In addition, a lack of specific referral pathways has been reported. Utilization rates for adult hearing aids in people with severe or profound loss are 70% to 90%, but uptake in adults for cochlear implants is less than 10%.

Therefore, the aim of this research project is to investigate the knowledge about medical interventions in moderate to severe hearing loss and the knowledge about reimbursement criteria of hearing implants of otorhinolaryngologists in a secondary setting in Brabant.

The study group will consist of a maximum of 100 geographically selected otorhinolaryngologists aged 25-70 years in a secondary setting in Brabant. A subselection will be made from the reachable otorhinolaryngologists in the region of Brabant. Recruitment will be discontinued when a maximum of 100 otorhinolaryngologists has been reached. A specific questionnaire will be systematically reviewed with the participants during an interview in the first and third phase. There is no financial compensation for the participants.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sara Tryhou, Bachelor; Phone Number: +32474105120; Email: sara.tryhou@uzbrussel.be
• Study Contact Backup: Name: Patrick D'Haese, Professor; Phone Number: +32473719736; Email: patrick.dhaese@vub.ac.be

Study Locations

• Belgium
  • Vlaams-Brabant
    • Brussel, Vlaams-Brabant, Belgium, 1000
      • Recruiting
      • UZ Brussel
      • Contact: Vedat Topsakal, Professor; Email: vedat.topsakal@uzbrussel.be
      • Sub-Investigator: Sara Tryhou, Bachelor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Otorhinolaryngologists working in a secondary setting
• Dutch and French speaking

Exclusion Criteria:

• Otorhinolaryngologists working in a tertiary setting attached to a university

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Interview; This will be evaluated through a specific questionnaire that will be systematically gone over with the participants during an interview in the first and third phases.	Behavioral: Interview; This will be evaluated through a specific questionnaire that will be systematically gone over with the participants during an interview in the first and third phases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior change: Questionnaire	Change in referral pattern	through study completion, an average of 1 year
Knowledge: Questionnaire:	Increased knowledge of hearing implant interventions and reimbursement criteria among otorhinolaryngologists in a secondary setting.	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Vedat Topsakal, Professor, UZ Brussel / VUB

Publications and helpful links

General Publications

• Buchman CA, Gifford RH, Haynes DS, Lenarz T, O'Donoghue G, Adunka O, Biever A, Briggs RJ, Carlson ML, Dai P, Driscoll CL, Francis HW, Gantz BJ, Gurgel RK, Hansen MR, Holcomb M, Karltorp E, Kirtane M, Larky J, Mylanus EAM, Roland JT Jr, Saeed SR, Skarzynski H, Skarzynski PH, Syms M, Teagle H, Van de Heyning PH, Vincent C, Wu H, Yamasoba T, Zwolan T. Unilateral Cochlear Implants for Severe, Profound, or Moderate Sloping to Profound Bilateral Sensorineural Hearing Loss: A Systematic Review and Consensus Statements. JAMA Otolaryngol Head Neck Surg. 2020 Oct 1;146(10):942-953. doi: 10.1001/jamaoto.2020.0998.
• D'Haese PSC, De Bodt M, Van Rompaey V, Van de Heyning P. Awareness of Hearing Loss in Older Adults: Results of a Survey Conducted in 500 Subjects Across 5 European Countries as a Basis for an Online Awareness Campaign. Inquiry. 2018 Jan-Dec;55:46958018759421. doi: 10.1177/0046958018759421.
• Sorkin DL. Access to cochlear implantation. Cochlear Implants Int. 2013 Mar;14 Suppl 1(Suppl 1):S1. doi: 10.1179/1467010013Z.00000000081. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: May 28, 2021
• First Submitted That Met QC Criteria: June 18, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): October 29, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness
• Other Study ID Numbers: awareness

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No