Clinical trial NCT04942327: Awareness Among Hearing Enhancement Interventions and Reimbursement Criteria of Hearing Implants
Official title: How Well Informed is a Otorhynolaryngologist in a Secondary Setting About the Hearing Enhancement Interventions and Reimbursement Criteria Related to Hearing Implants?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Awareness
Hearing Impairment
Otorhinolaryngologic Surgical Procedures
Implant
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Otorhinolaryngologists working in a tertiary setting attached to a university

Primary outcomes:
measure: Behavior change: Questionnaire
timeFrame: through study completion, an average of 1 year
measure: Knowledge: Questionnaire:
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
state: Vlaams-Brabant
Study officials:
affiliation: UZ Brussel / VUB
name: Vedat Topsakal, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: 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.