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Awareness Among Hearing Enhancement Interventions and Reimbursement Criteria of Hearing Implants

Primary Purpose

Awareness, Hearing Impairment, Otorhinolaryngologic Surgical Procedures

Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Interview
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Awareness

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Otorhinolaryngologists working in a tertiary setting attached to a university

Sites / Locations

  • UZ BrusselRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Interview

Arm Description

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.

Outcomes

Primary Outcome Measures

Behavior change: Questionnaire
Change in referral pattern
Knowledge: Questionnaire:
Increased knowledge of hearing implant interventions and reimbursement criteria among otorhinolaryngologists in a secondary setting.

Secondary Outcome Measures

Full Information

First Posted
May 28, 2021
Last Updated
October 27, 2021
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04942327
Brief Title
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

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 18, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Awareness, Hearing Impairment, Otorhinolaryngologic Surgical Procedures, Implant

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interview
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interview
Intervention Description
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.
Primary Outcome Measure Information:
Title
Behavior change: Questionnaire
Description
Change in referral pattern
Time Frame
through study completion, an average of 1 year
Title
Knowledge: Questionnaire:
Description
Increased knowledge of hearing implant interventions and reimbursement criteria among otorhinolaryngologists in a secondary setting.
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sara Tryhou, Bachelor
Phone
+32474105120
Email
sara.tryhou@uzbrussel.be
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick D'Haese, Professor
Phone
+32473719736
Email
patrick.dhaese@vub.ac.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vedat Topsakal, Professor
Organizational Affiliation
UZ Brussel / VUB
Official's Role
Principal Investigator
Facility Information:
Facility Name
UZ Brussel
City
Brussel
State/Province
Vlaams-Brabant
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vedat Topsakal, Professor
Email
vedat.topsakal@uzbrussel.be
First Name & Middle Initial & Last Name & Degree
Sara Tryhou, Bachelor

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32857157
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.
Results Reference
background
PubMed Identifier
29529899
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.
Results Reference
background
PubMed Identifier
23453144
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.
Results Reference
background

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Awareness Among Hearing Enhancement Interventions and Reimbursement Criteria of Hearing Implants

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