Addressing Barriers to Adult Hearing Healthcare

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Addressing Barriers to Adult Hearing Healthcare

Conditions
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Hearing Loss, Geriatric Disorder

Intervention / Treatment
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* Other: Tele-HS
* Other: PCP encouragement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: At-Home Telephone Screening (Tele-HS)<br>Subjects receive printed educational materials about hearing loss and access to at-home Tele-HS | Other: Tele-HS<br>* Patients will be given information on the Tele-HS and given access to take the screening at home or in-office, depending on arm.<br>|
| Experimental: PCP Encouragement, At-Home Tele-HS<br>Subjects receives encouragement from primary care provider (PCP) or hearing screening, printed materials and access to at-home Tele-HS. | Other: Tele-HS<br>* Patients will be given information on the Tele-HS and given access to take the screening at home or in-office, depending on arm.<br>Other: PCP encouragement<br>* Patients will or will not either receive PCP encouragement to do the Tele-HS.<br>|
| Experimental: PCP Encouragement, In-Office Tele-HS<br>Subjects receives PCP encouragement for hearing screening, printed materials and access to Tele-HS while in clinic. | Other: Tele-HS<br>* Patients will be given information on the Tele-HS and given access to take the screening at home or in-office, depending on arm.<br>Other: PCP encouragement<br>* Patients will or will not either receive PCP encouragement to do the Tele-HS.<br>|
| No Intervention: CHEER Cohort (non-randomized)<br>Participants will complete a one page questionnaire related to Red Flag conditions during a routine Otolaryngology appointment for suspected hearing loss. The audiologist will be complete a questionnaire about the participants audiological assessment including Red Flag conditions. The Otolaryngology provider will complete a questionnaire about the participants otoscopic exam findings, Red Flag conditions, and indicate if any other conditions exist that me be considered a medical contraindication to hearing aid fitting. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion of Tele-HS screen | The proportion (%) of subjects in Groups 1 and 2 who take the test will be compared to those in Group 3. | 2 months of PCP appointment (day 1) | 
| Medical conditions for which the FDA requires physician evaluation prior to hearing aid fitting | 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) | 1 day (following completion of Red Flag questionnaires by patient, audiologist and medical provider) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scheduling of follow-up audiological testing | 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. | 4 months of date of Tele-HS | 
| Completion of follow-up audiological testing | 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. | 4 months of date of Tele-HS | 
| Completion of plan for appropriate hearing loss intervention, if applicable | 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. | 4 months of date of Tele-HS |