Addressing Barriers to Adult Hearing Healthcare

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss; Geriatric Disorder
• Intervention / Treatment: Other: Tele-HS; Other: PCP encouragement

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1146
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
  • New York
    • New Hyde Park, New York, United States, 11040
      • Northwell Health
    • New York, New York, United States, 10029
      • New York Eye and Ear of Mount Sinai
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Oregon
    • Bend, Oregon, United States, 97701
      • Central Oregon ENT
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: At-Home Telephone Screening (Tele-HS); Subjects receive printed educational materials about hearing loss and access to at-home Tele-HS	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.
EXPERIMENTAL: 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.	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.; Other: PCP encouragement; Patients will or will not either receive PCP encouragement to do the Tele-HS.
EXPERIMENTAL: PCP Encouragement, In-Office Tele-HS; Subjects receives PCP encouragement for hearing screening, printed materials and access to Tele-HS while in clinic.	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.; Other: PCP encouragement; Patients will or will not either receive PCP encouragement to do the Tele-HS.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Attitudes towards hearing loss	Analysis of attitudes towards hearing loss using the ALHQ questionnaire and focus group discussions	2 days
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)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Sherri Smith, PhD, Duke University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2016
• Primary Completion (ACTUAL): August 27, 2021
• Study Completion (ACTUAL): August 27, 2021

Study Registration Dates

• First Submitted: October 6, 2016
• First Submitted That Met QC Criteria: October 6, 2016
• First Posted (ESTIMATE): October 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: Pro00070422; R21DC015003-01 (NIH); R33DC015003 (NIH); Pro00086182 (OTHER: Duke University Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be deposited into the Duke Research Data Repository (RDR), an openly accessible preservation archive maintained by the Duke University Libraries. The RDR will assign appropriate metadata (Dublin Core) for discoverability and provide a Digital Object Identifier (DOI) for persistent access and unique identification of the data. The data will be preserved in the RDR for the long-term according to RDR policies and procedures. When the data are transferred to the RDR, data curators will review deposits to help ensure they are complete and in a structure and format that supports long-term preservation, access, and reuse. The RDR provides for automated backup of all data, which provides an added layer of protection and security for the data.
• IPD Sharing Time Frame: At the end of the study data analysis
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No