Addressing Barriers to Adult Hearing Healthcare

Hearing Loss Clinical Trial

Official title:

Addressing Barriers to Adult Hearing Healthcare

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02928107
• Other study ID #: Pro00070422
• Secondary ID: R21DC015003-01R3
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Geriatric Disorder
• Hearing Loss

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