Comparison of In-Person Versus Remote Cochlear Implant Candidacy Evaluations

February 11, 2020 updated by: Matthew Bush, MD

Comparison of Patient & Provider Outcomes With In-Person Versus Remote Cochlear Implant Candidacy Evaluations

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: In-Person CI Counseling Session
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.
Other: In-Person CI Counseling
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).
Experimental: Remote CI Counseling Session
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.
Device: Remote CI Counseling
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.
Other Names:
  • Polycom 500 series

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
(Aim 1): Comparison of Remote Audiological Testing Scores with In-Person Audiological Testing Scores
Time Frame: 2 weeks
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.
2 weeks
(Aim 2): Remote Cochlear Implant Counseling Completion Rate
Time Frame: 45 minutes
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.
45 minutes
(Aim 2): In-Person Cochlear Implant Counseling Participant Feedback
Time Frame: 10 minutes
Participants in Aim 2 that receive an in-person session will complete a 6-question satisfaction questionnaire post cochlear implant counseling session.
10 minutes
(Aim 2): In-Person Cochlear Implant Counseling Provider Feedback
Time Frame: 10 minutes
Provider(s) in Aim 2 that deliver in-person session(s) will complete a 6-question satisfaction questionnaire post cochlear implant counseling session.
10 minutes
(Aim 2): Remote Cochlear Implant Counseling Participant Feedback
Time Frame: 10 minutes
Participants in Aim 2 that receive a remote session will complete a 13-question satisfaction questionnaire post cochlear implant counseling session.
10 minutes
(Aim 2): Remote Cochlear Implant Counseling Provider Feedback
Time Frame: 10 minutes
Provider(s) in Aim 2 that deliver remote session(s) will complete a 13-question satisfaction questionnaire post cochlear implant counseling session.
10 minutes
(Aim 2): Stage of Change toward Seeking Hearing Rehabilitation
Time Frame: 2-4 weeks
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.
2-4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matthew Bush, MD

Investigators

  • Principal Investigator: Matthew L Bush, MD, University of Kentucky Department of Otolaryngology - Head & Neck Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

December 10, 2017

Study Completion (Actual)

December 10, 2017

Study Registration Dates

First Submitted

February 6, 2016

First Submitted That Met QC Criteria

February 11, 2016

First Posted (Estimate)

February 17, 2016

Study Record Updates

Last Update Posted (Actual)

February 13, 2020

Last Update Submitted That Met QC Criteria

February 11, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-0572-P2H

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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