Comparison of In-Person Versus Remote Cochlear Implant Candidacy Evaluations

NCT ID: NCT02684175

Last Updated: 2020-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-10

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.

Conditions

Hearing Loss; Hearing Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

In-Person CI Counseling

Intervention Type: OTHER

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).

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.

Group Type: EXPERIMENTAL

Remote CI Counseling

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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).

Intervention Type: OTHER

Other Intervention Names

Polycom 500 series

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Matthew Bush, MD

OTHER

Sponsor Role: lead

Responsible Party

Matthew Bush, MD

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Matthew L Bush, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky Department of Otolaryngology - Head & Neck Surgery

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23364333 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30832542 (View on PubMed)

Other Identifiers

15-0572-P2H

Identifier Type: -

Identifier Source: org_study_id