Addressing Barriers to Adult Hearing Healthcare

Duke University

Status: Completed

Conditions: Hearing Loss; Geriatric Disorder

Treatments: Other: Tele-HS; Other: PCP encouragement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02928107

R21DC015003-01 (U.S. NIH Grant/Contract)

Pro00086182 (Other Identifier)

R33DC015003 (U.S. NIH Grant/Contract)

Pro00070422

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,146 patients

Sex: All

Ages: 65 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,146 participants in 4 patient groups

At-Home Telephone Screening (Tele-HS)

Experimental group

Description:

Subjects receive printed educational materials about hearing loss and access to at-home Tele-HS

Treatment:

Other: Tele-HS

PCP Encouragement, At-Home Tele-HS

Experimental group

Description:

Subjects receives encouragement from primary care provider (PCP) or hearing screening, printed materials and access to at-home Tele-HS.

Treatment:

Other: PCP encouragement

Other: Tele-HS

PCP Encouragement, In-Office Tele-HS

Experimental group

Description:

Subjects receives PCP encouragement for hearing screening, printed materials and access to Tele-HS while in clinic.

Treatment:

Other: PCP encouragement

Other: Tele-HS

CHEER Cohort (non-randomized)

No Intervention group

Description:

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.