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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02928107
Other study ID # Pro00070422
Secondary ID R21DC015003-01R3
Status Completed
Phase N/A
First received
Last updated
Start date October 31, 2016
Est. completion date August 27, 2021

Study information

Verified date November 2021
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1146
Est. completion date August 27, 2021
Est. primary completion date August 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan
United States Central Oregon ENT Bend Oregon
United States University of Texas Southwestern Medical Center Dallas Texas
United States Duke University Medical Center Durham North Carolina
United States Northwell Health New Hyde Park New York
United States New York Eye and Ear of Mount Sinai New York New York

Sponsors (2)

Lead Sponsor Collaborator
Duke University National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Significance of medical conditions requiring medical evaluation prior to hearing aid fitting Analysis to determine what medical conditions should require medical evaluation prior to hearing aid fitting (CHEER Cohort) 1 day, completion of patient, audiologist and provider questionnaires
Other Cost to conduct telephone hearing screening in the Primary Care clinic setting Cost to conduct hearing screening based on costs of educational material, telephone screening test, provider time and clinic space. (Both Cohorts) 1 day
Other Attitudes towards hearing loss Analysis of attitudes towards hearing loss using the ALHQ questionnaire and focus group discussions 2 days
Other Attitudes of communication partners regarding hearing loss Evaluation of how attitudes of significant others impact decision making to pursue hearing screening, diagnostic testing, and intervention. 1 day, completion of the Significant Other Hearing Questionnaire (SOS-HEAR)
Primary 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)
Primary 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 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
Secondary 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
Secondary 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
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