Addressing Barriers to Adult Hearing Healthcare

  • STATUS
    Recruiting
  • End date
    Jun 27, 2021
  • participants needed
    1500
  • sponsor
    Duke University
Updated on 27 January 2021
seizure
hard of hearing
fit hearing aid
audiogram
hearing screening

Summary

The aim of this project is to develop evidence that can inform hearing health care best practices for adults between the ages of 65-75, and determine what level of involvement by the primary care practitioner (PCP) is required to inform and encourage adults age 65-75 to follow through with routine hearing screening.

This study also aims to evaluate the accuracy of assessment of medical conditions for which the FDA requires physician evaluation and management prior to hearing aid fitting, and determine which medical conditions should require medical evaluation prior to hearing aid fitting.

The results of this study should provide information to implement changes in health care policy to facilitate accessible and affordable hearing health care.

Description

Age-related hearing loss is the third-most common chronic condition affecting older adults in the US (data from Healthy People 2020 US Dept of Health and Human Services). This study aims to improve the understanding of attitudes, barriers and facilitators needed to improve hearing health care delivery. Two study cohorts of study participants between the ages of 65

  • 75 are proposed.

The first cohort of participants include healthy adults being seen by a primary care provider (PCP) for a routine appointment. Each participating primary care practice is assigned to one of three different telephone hearing screening strategies that include progressive levels of PCP time and guidance to complete telephone-based hearing screening. Those who fail a telephone hearing screening go on to a medical referral study and receive (1) diagnostic audiological testing and (2) determination of the reliability and validity of identification of conditions that should require medical referral prior to hearing aid provision (called FDA 'Red Flag' conditions, including conditions such as sudden hearing loss, cerumen impaction, conductive hearing loss, dizziness, external deformity, ear drainage). We will evaluate the proportion of subjects in Groups 1 and 2 who dial the phone number and complete the telephone hearing test at or within two months of their PCP visit, relative to Group 3, and the proportion of subjects in all groups who: a) schedule and b) complete the visit for diagnostic audiological testing, and subsequently, c) complete a plan for appropriate hearing loss intervention, if indicated, within four months of initial hearing screening. Enrollment in this cohort is complete. 955 subjects were screened for eligibility. Of those, 660 patients were enrolled.

The second cohort includes adults who are being seen for a routine appointment for a complaint of hearing loss at one of several participating Ear, Nose, and Throat (ENT) practices in the CHEER network. Information about Red Flag conditions will be obtained from the patient, audiologist, and ENT provider. This information, along with Red Flag data from the PCP Cohort, will be used to evaluate the accuracy of assessment of medical conditions for which the FDA requires physician evaluation and management prior to hearing aid fitting, and determine which medical conditions should require medical evaluation prior to hearing aid fitting. Enrollment in this cohort is ongoing. The anticipated enrollment goal is 500 subjects.

Details
Condition Deafness, Hearing Loss, Auditory Loss and Deafness, Geriatric Disorder, Hearing Impairment, decreased hearing, hard of hearing, hypoacusis
Treatment Tele-HS, PCP encouragement
Clinical Study IdentifierNCT02928107
SponsorDuke University
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 65 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Hearing Loss or Hearing Impairment or Auditory Loss and Deafness or Geriatric Disorder?
Do you have any of these conditions: hypoacusis or decreased hearing or Deafness or Auditory Loss and Deafness or hard of hearing or Hearing Impairment or Hearing Loss or Geriatric Disord...?
Do you have any of these conditions: Geriatric Disorder or decreased hearing or Hearing Loss or Deafness or hard of hearing or hypoacusis or Hearing Impairment or Auditory Loss and Deafne...?
Do you have any of these conditions: hard of hearing or Hearing Impairment or Auditory Loss and Deafness or hypoacusis or Hearing Loss or Deafness or Geriatric Disorder or decreased heari...?
-75 years of age
Being seen by an OHNS/ENT provider for a complaint of hearing loss
Is scheduled to have an audiogram as standard of care for complaint of hearing loss
No prior diagnosis of hearing loss by a medical professional or history of hearing aid use

Exclusion Criteria

Not between the ages of 65-75
Current or past hearing aid user
Prior diagnosis of hearing loss or hearing aid user
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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