Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1146 participants
INTERVENTIONAL
2016-10-31
2021-08-27
Brief Summary
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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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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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At-Home Telephone Screening (Tele-HS)
Subjects receive printed educational materials about hearing loss and access to at-home Tele-HS
Tele-HS
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, At-Home Tele-HS
Subjects receives encouragement from primary care provider (PCP) or hearing screening, printed materials and access to at-home Tele-HS.
Tele-HS
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
Patients will or will not either receive PCP encouragement to do the Tele-HS.
PCP Encouragement, In-Office Tele-HS
Subjects receives PCP encouragement for hearing screening, printed materials and access to Tele-HS while in clinic.
Tele-HS
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
Patients will or will not either receive PCP encouragement to do the Tele-HS.
CHEER Cohort (non-randomized)
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.
No interventions assigned to this group
Interventions
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Tele-HS
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
Patients will or will not either receive PCP encouragement to do the Tele-HS.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
* 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:
* Not between the ages of 65-75
* Current or past hearing aid user
* Prior diagnosis of hearing loss or hearing aid user
65 Years
75 Years
ALL
Yes
Sponsors
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National Institute on Deafness and Other Communication Disorders (NIDCD)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Sherri Smith, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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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
Countries
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References
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Dubno JR, Majumder P, Bettger JP, Dolor RJ, Eifert V, Francis HW, Pieper CF, Schulz KA, Silberberg M, Smith SL, Walker AR, Witsell DL, Tucci DL. A pragmatic clinical trial of hearing screening in primary care clinics: cost-effectiveness of hearing screening. Cost Eff Resour Alloc. 2022 Jun 25;20(1):26. doi: 10.1186/s12962-022-00360-5.
Bettger JP, Dolor RJ, Witsell DL, Dubno JR, Pieper CF, Walker AR, Silberberg M, Schulz KA, Majumder P, Juhlin E, Smith SL, Francis HW, Tucci DL. Comparative implementation-effectiveness of three strategies to perform hearing screening among older adults in primary care clinics: study design and protocol. BMC Geriatr. 2020 May 11;20(1):170. doi: 10.1186/s12877-020-01576-x.
Other Identifiers
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