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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
1,146
Patients will be given information on the Tele-HS and given access to take the screening at home or in-office, depending on arm.
Patients will or will not either receive PCP encouragement to do the Tele-HS.
University of Michigan
Ann Arbor, Michigan, United States
Northwell Health
New Hyde Park, New York, United States
New York Eye and Ear of Mount Sinai
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Central Oregon ENT
Bend, Oregon, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
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.
Time frame: 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)
Time frame: 1 day (following completion of Red Flag questionnaires by patient, audiologist and medical provider)
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.
Time frame: 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.
Time frame: 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.
Time frame: 4 months of date of Tele-HS
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.