Awareness Among Hearing Enhancement Interventions and Reimbursement Criteria of Hearing Implants

Hearing Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04942327
• Other study ID #: Awareness
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: Sara Tryhou, Bachelor
• Phone: +32474105120
• Email: sara.tryhou[@]uzbrussel.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• Otorhinolaryngologists working in a secondary setting

• Dutch and French speaking

Exclusion Criteria:

• Otorhinolaryngologists working in a tertiary setting attached to a university

Related Conditions & MeSH terms

• Awareness
• Deafness
• Hearing Impairment
• Hearing Loss
• Implant
• Otorhinolaryngologic Surgical Procedures

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussel	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View Citation

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. — View Citation

Sorkin DL. Access to cochlear implantation. Cochlear Implants Int. 2013 Mar;14 Suppl 1:S1. doi: 10.1179/1467010013Z.00000000081. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavior change: Questionnaire	Change in referral pattern	through study completion, an average of 1 year
Primary	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

External Links

•   Background information