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OpenTrials
Completed

NCT Number: NCT02928107

Addressing Barriers to Adult Hearing Healthcare

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.

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Key information

Age range

65 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Primary Care Cohort:

Inclusion criteria

  • 65-75 years of age
  • Being seen by PCP for non-acute follow-up or annual appointment for primary care
  • No prior history of hearing aid use or self-reported diagnosis of hearing loss

Exclusion criteria

  • Not between the ages of 65-75
  • Current or past hearing aid user
  • Patient has been tested by an audiologist in the past and self-reports a hearing loss diagnosis
  • Being seen by the PCP for an acute illness

CHEER Cohort:

Inclusion criteria

  • 65-75 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

Treatment and study plan

Tele-HS

Other

Patients will be given information on the Tele-HS and given access to take the screening at home or in-office, depending on arm.

PCP encouragement

Other

Patients will or will not either receive PCP encouragement to do the Tele-HS.

Primary outcomes

  1. Completion of Tele-HS screen

    Time frame: 2 months of PCP appointment (day 1)

    The proportion (%) of subjects in Groups 1 and 2 who take the test will be compared to those in Group 3.

  2. Medical conditions for which the FDA requires physician evaluation prior to hearing aid fitting

    Time frame: 1 day (following completion of Red Flag questionnaires by patient, audiologist and medical provider)

    Analysis of medical conditions for which the FDA requires physician evaluation prior to hearing aid fitting by comparing red flag assessments from patient, audiologist and ENT provider (CHEER Cohort)

Secondary outcomes

  1. Scheduling of follow-up audiological testing

    Time frame: 4 months of date of Tele-HS

    The proportion (%) of subjects in Groups 1 and 2 who fail the Tele-HS and schedule follow-up testing compared to those in Group 3.

  2. Completion of follow-up audiological testing

    Time frame: 4 months of date of Tele-HS

    The proportion (%) of subjects in Groups 1 and 2 who fail the Tele-HS and complete follow-up testing compared to those in Group 3.

  3. Completion of plan for appropriate hearing loss intervention, if applicable

    Time frame: 4 months of date of Tele-HS

    The proportion (%) of subjects in Groups 1 and 2 who fail the Tele-HS, complete follow-up testing, and complete a plan for hearing loss intervention, if applicable, compared to those in Group 3.

Other outcomes

  1. Significance of medical conditions requiring medical evaluation prior to hearing aid fitting

    Time frame: 1 day, completion of patient, audiologist and provider questionnaires

    Analysis to determine what medical conditions should require medical evaluation prior to hearing aid fitting (CHEER Cohort)

  2. Cost to conduct telephone hearing screening in the Primary Care clinic setting

    Time frame: 1 day

    Cost to conduct hearing screening based on costs of educational material, telephone screening test, provider time and clinic space. (Both Cohorts)

  3. Attitudes towards hearing loss

    Time frame: 2 days

    Analysis of attitudes towards hearing loss using the ALHQ questionnaire and focus group discussions

  4. Attitudes of communication partners regarding hearing loss

    Time frame: 1 day, completion of the Significant Other Hearing Questionnaire (SOS-HEAR)

    Evaluation of how attitudes of significant others impact decision making to pursue hearing screening, diagnostic testing, and intervention.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Oct 10, 2016
Registry last updated
Nov 9, 2021

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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