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Comparison of In-Person Versus Remote Cochlear Implant Candidacy Evaluations

Primary Purpose

Hearing Loss, Hearing Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Remote CI Counseling
In-Person CI Counseling
Sponsored by
Matthew Bush, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hearing Loss focused on measuring Audiometry, Cochlear Implants, Adult, Telemedicine, Health Services Accessibility, Rural Population, Technology Assessment, Biomedical

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Adults (>18) who are current patients at the University of Kentucky Morehead Clinic
  2. Adults who have moderate to profound hearing loss
  3. Adults who can speak and understand English since cochlear implantation candidacy testing is performed using standardized word lists in English

Exclusion Criteria:

  1. Adults with prelingual deafness
  2. Adults who use sign language as a primary means of communication
  3. Adults with active otological infections with otorrhea or cerumen impaction seen on otoscopy
  4. Pregnant women since pregnant women are not cochlear implant surgical candidates

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

In-Person CI Counseling Session

Remote CI Counseling Session

Arm Description

Participants (n=6) randomized to receive an in-person CI counseling session will receive what normally occurs with patients pursuing cochlear implantation. The counseling will last 30-45 minutes and consists 5 key components: an explanation of the patient's hearing testing results, a discussion of the impact of hearing loss on the patient's life, treatment options for hearing loss including hearing aid amplification and cochlear implantation, an explanation of how CIs function and the necessary steps in candidacy and rehabilitation, and an outline of the expected outcomes following cochlear implantation.

Participants (n=6) randomized to receive a remote CI counseling session will be receiving the counseling session remotely. The participants will be counseled remotely by the audiologist located in Lexington, KY via the telemedicine system (intervention). This counseling will last 30-45 minutes and consists 5 key components: an explanation of the patient's hearing testing results, a discussion of the impact of hearing loss on the patient's life, treatment options for hearing loss including hearing aid amplification and cochlear implantation, explanation of how CIs function and the necessary steps in candidacy and rehabilitation, and an outline of the expected outcomes following cochlear implantation.

Outcomes

Primary Outcome Measures

(Aim 1): Comparison of Remote Audiological Testing Scores with In-Person Audiological Testing Scores
Arizona Biological (AzBio) scores gathered remotely via the telemedicine system will be compared to AzBio scores gathered via in-person (face-to-face) per participant.
(Aim 2): Remote Cochlear Implant Counseling Completion Rate
The number of participants that enroll into Aim 2 will be recorded and compared to the number of participants that complete all study-related activities within this Aim.
(Aim 2): In-Person Cochlear Implant Counseling Participant Feedback
Participants in Aim 2 that receive an in-person session will complete a 6-question satisfaction questionnaire post cochlear implant counseling session.
(Aim 2): In-Person Cochlear Implant Counseling Provider Feedback
Provider(s) in Aim 2 that deliver in-person session(s) will complete a 6-question satisfaction questionnaire post cochlear implant counseling session.
(Aim 2): Remote Cochlear Implant Counseling Participant Feedback
Participants in Aim 2 that receive a remote session will complete a 13-question satisfaction questionnaire post cochlear implant counseling session.
(Aim 2): Remote Cochlear Implant Counseling Provider Feedback
Provider(s) in Aim 2 that deliver remote session(s) will complete a 13-question satisfaction questionnaire post cochlear implant counseling session.
(Aim 2): Stage of Change toward Seeking Hearing Rehabilitation
Participants in Aim 2 will complete the University of Rhode Island (URICA) questionnaire post cochlear implant counseling session. This questionnaire will determine the participant's stage of change toward seeking hearing rehabilitation. These URICA scores will be compared to URICA scores gathered in Aim 1 for each participant.

Secondary Outcome Measures

Full Information

First Posted
February 6, 2016
Last Updated
February 11, 2020
Sponsor
Matthew Bush, MD
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1. Study Identification

Unique Protocol Identification Number
NCT02684175
Brief Title
Comparison of In-Person Versus Remote Cochlear Implant Candidacy Evaluations
Official Title
Comparison of Patient & Provider Outcomes With In-Person Versus Remote Cochlear Implant Candidacy Evaluations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 10, 2017 (Actual)
Study Completion Date
December 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Matthew Bush, MD

4. Oversight

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

5. Study Description

Brief Summary
The objective of this study is to compare remote and in-person audiological cochlear implant candidacy evaluations (including audiological (hearing) testing and counseling sessions) in a rural Appalachian region.
Detailed Description
In Aim 1, participants (N=42) will receive both an in-person (standard of care) and remote (experimental) comprehensive audiological evaluation.Participants will be randomized to receive both sessions in a particular sequence (in-person, remote versus remote, in-person) to reduce order effect. Remote audiological sessions will involve face-to-face communication and testing over a high-speed hard wired connection (10 Mgb/s) conducted within the University of Kentucky firewall protection using a Polycom 500 series teleconference audio and live video set-up. The audiologist will direct the remote audiological evaluation with the participant (in the UK Otolaryngology (ENT) practice in Morehead, KY) from a work station at the Otolaryngology (ENT) practice in Lexington, KY. Evaluations will include pure-tone air and bone conduction thresholds (level of hearing ability) along with speech audiometry (speech recognition thresholds and word recognition scores). Scores from the Arizona Biological (AzBio) test (speech recognition) completed remotely and in-person will be compared for each person to determine equivalence. Upon enrollment, participants will fill out a demographic questionnaire along with an adapted version of the University of Rhode Island Change Assessment (URICA) questionnaire, assessing their current stage of change toward seeking hearing rehabilitation. Aim 2 will involve participants from Aim 1 (N=12). Half of the cohort (n=6) will be randomized to receive a remote cochlear implant counseling session (experimental) and the other half (n=6) will be randomized to receive an in-person cochlear implant counseling session (standard of care). Both sessions will occur in the ENT practice in Morehead, KY with an audiologist but the audiologist will be physically located in the ENT practice in Lexington, KY directing the session during the remote sessions. The counseling session lasts 30-45 minutes and consists of 5 key components: an explanation of the patient's hearing testing results, a discussion of the impact of hearing loss on the patient's life, treatment options for hearing loss including hearing aid amplification and cochlear implantation, an explanation of how cochlear implants function and the necessary steps in candidacy and rehabilitation, and an outline of the expected outcomes following cochlear implantation. After participants receive either remote or in-person session, they will complete a satisfaction questionnaire on the session and the URICA questionnaire.The URICA questionnaire is a validated assessment tool measuring an individuals' motivation for change by providing a score that places them within one of the four categories: precontemplation, contemplation, action and maintenance (Laplante-Lavesque, Hickson, & Worral, 2013). After each session, the audiologist will fill out a satisfaction questionnaire.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss, Hearing Disorders
Keywords
Audiometry, Cochlear Implants, Adult, Telemedicine, Health Services Accessibility, Rural Population, Technology Assessment, Biomedical

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In-Person CI Counseling Session
Arm Type
Active Comparator
Arm Description
Participants (n=6) randomized to receive an in-person CI counseling session will receive what normally occurs with patients pursuing cochlear implantation. The counseling will last 30-45 minutes and consists 5 key components: an explanation of the patient's hearing testing results, a discussion of the impact of hearing loss on the patient's life, treatment options for hearing loss including hearing aid amplification and cochlear implantation, an explanation of how CIs function and the necessary steps in candidacy and rehabilitation, and an outline of the expected outcomes following cochlear implantation.
Arm Title
Remote CI Counseling Session
Arm Type
Experimental
Arm Description
Participants (n=6) randomized to receive a remote CI counseling session will be receiving the counseling session remotely. The participants will be counseled remotely by the audiologist located in Lexington, KY via the telemedicine system (intervention). This counseling will last 30-45 minutes and consists 5 key components: an explanation of the patient's hearing testing results, a discussion of the impact of hearing loss on the patient's life, treatment options for hearing loss including hearing aid amplification and cochlear implantation, explanation of how CIs function and the necessary steps in candidacy and rehabilitation, and an outline of the expected outcomes following cochlear implantation.
Intervention Type
Device
Intervention Name(s)
Remote CI Counseling
Other Intervention Name(s)
Polycom 500 series
Intervention Description
The remote setup includes a 500 series teleconference audio and video live set-up. The teleconference set-up will be situated on a telemedicine cart and placed within the sound-proof booth at the testing site (UK ENT practice in Morehead, KY). The audiologist will deliver the session remotely.
Intervention Type
Other
Intervention Name(s)
In-Person CI Counseling
Intervention Description
The standard face-to-face counseling that will occur between the participant and audiologist is the standard of care. No technology will be used. The audiologist will deliver the session face-to-face with the participant in the same room (standard practice).
Primary Outcome Measure Information:
Title
(Aim 1): Comparison of Remote Audiological Testing Scores with In-Person Audiological Testing Scores
Description
Arizona Biological (AzBio) scores gathered remotely via the telemedicine system will be compared to AzBio scores gathered via in-person (face-to-face) per participant.
Time Frame
2 weeks
Title
(Aim 2): Remote Cochlear Implant Counseling Completion Rate
Description
The number of participants that enroll into Aim 2 will be recorded and compared to the number of participants that complete all study-related activities within this Aim.
Time Frame
45 minutes
Title
(Aim 2): In-Person Cochlear Implant Counseling Participant Feedback
Description
Participants in Aim 2 that receive an in-person session will complete a 6-question satisfaction questionnaire post cochlear implant counseling session.
Time Frame
10 minutes
Title
(Aim 2): In-Person Cochlear Implant Counseling Provider Feedback
Description
Provider(s) in Aim 2 that deliver in-person session(s) will complete a 6-question satisfaction questionnaire post cochlear implant counseling session.
Time Frame
10 minutes
Title
(Aim 2): Remote Cochlear Implant Counseling Participant Feedback
Description
Participants in Aim 2 that receive a remote session will complete a 13-question satisfaction questionnaire post cochlear implant counseling session.
Time Frame
10 minutes
Title
(Aim 2): Remote Cochlear Implant Counseling Provider Feedback
Description
Provider(s) in Aim 2 that deliver remote session(s) will complete a 13-question satisfaction questionnaire post cochlear implant counseling session.
Time Frame
10 minutes
Title
(Aim 2): Stage of Change toward Seeking Hearing Rehabilitation
Description
Participants in Aim 2 will complete the University of Rhode Island (URICA) questionnaire post cochlear implant counseling session. This questionnaire will determine the participant's stage of change toward seeking hearing rehabilitation. These URICA scores will be compared to URICA scores gathered in Aim 1 for each participant.
Time Frame
2-4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults (>18) who are current patients at the University of Kentucky Morehead Clinic Adults who have moderate to profound hearing loss Adults who can speak and understand English since cochlear implantation candidacy testing is performed using standardized word lists in English Exclusion Criteria: Adults with prelingual deafness Adults who use sign language as a primary means of communication Adults with active otological infections with otorrhea or cerumen impaction seen on otoscopy Pregnant women since pregnant women are not cochlear implant surgical candidates
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew L Bush, MD
Organizational Affiliation
University of Kentucky Department of Otolaryngology - Head & Neck Surgery
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23364333
Citation
Laplante-Levesque A, Hickson L, Worrall L. Stages of change in adults with acquired hearing impairment seeking help for the first time: application of the transtheoretical model in audiologic rehabilitation. Ear Hear. 2013 Jul-Aug;34(4):447-57. doi: 10.1097/AUD.0b013e3182772c49.
Results Reference
background
PubMed Identifier
30832542
Citation
Fletcher KT, Dicken FW, Adkins MM, Cline TA, McNulty BN, Shinn JB, Bush ML. Audiology Telemedicine Evaluations: Potential Expanded Applications. Otolaryngol Head Neck Surg. 2019 Jul;161(1):63-66. doi: 10.1177/0194599819835541. Epub 2019 Mar 5.
Results Reference
result

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Comparison of In-Person Versus Remote Cochlear Implant Candidacy Evaluations

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