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Completed

NCT Number: NCT02684175

Comparison of 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.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote CI Counseling

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.

Other names: Polycom 500 series

In-Person CI Counseling

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).

Primary outcomes

  1. (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. (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.

  3. (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.

  4. (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.

  5. (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.

  6. (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.

  7. (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.

Sponsors and collaborators

Lead sponsor

Matthew Bush, MD

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2016
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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