Clinical trial NCT02684175: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Hearing Disorders
Keywords: Audiometry
Cochlear Implants
Adult
Telemedicine
Health Services Accessibility
Rural Population
Technology Assessment, Biomedical
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2016-02-17
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: (Aim 1): Comparison of Remote Audiological Testing Scores with In-Person Audiological Testing Scores
timeFrame: 2 weeks
measure: (Aim 2): Remote Cochlear Implant Counseling Completion Rate
timeFrame: 45 minutes
measure: (Aim 2): In-Person Cochlear Implant Counseling Participant Feedback
timeFrame: 10 minutes
measure: (Aim 2): In-Person Cochlear Implant Counseling Provider Feedback
timeFrame: 10 minutes
measure: (Aim 2): Remote Cochlear Implant Counseling Participant Feedback
timeFrame: 10 minutes
measure: (Aim 2): Remote Cochlear Implant Counseling Provider Feedback
timeFrame: 10 minutes
measure: (Aim 2): Stage of Change toward Seeking Hearing Rehabilitation
timeFrame: 2-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky Department of Otolaryngology - Head & Neck Surgery
name: Matthew L Bush, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.