Clinical trial NCT02928107: Addressing Barriers to Adult Hearing Healthcare
Official title: Addressing Barriers to Adult Hearing Healthcare
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Geriatric Disorder
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2016-10-10
Enrollment: 1146
Sex: ALL
Minimum age (years): 65
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Completion of Tele-HS screen
timeFrame: 2 months of PCP appointment (day 1)
measure: Medical conditions for which the FDA requires physician evaluation prior to hearing aid fitting
timeFrame: 1 day (following completion of Red Flag questionnaires by patient, audiologist and medical provider)
Secondary outcomes:
measure: Scheduling of follow-up audiological testing
timeFrame: 4 months of date of Tele-HS
measure: Completion of follow-up audiological testing
timeFrame: 4 months of date of Tele-HS
measure: Completion of plan for appropriate hearing loss intervention, if applicable
timeFrame: 4 months of date of Tele-HS
Other outcomes:
measure: Significance of medical conditions requiring medical evaluation prior to hearing aid fitting
timeFrame: 1 day, completion of patient, audiologist and provider questionnaires
measure: Cost to conduct telephone hearing screening in the Primary Care clinic setting
timeFrame: 1 day
measure: Attitudes towards hearing loss
timeFrame: 2 days
measure: Attitudes of communication partners regarding hearing loss
timeFrame: 1 day, completion of the Significant Other Hearing Questionnaire (SOS-HEAR)
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New Hyde Park
country: United States
facility: Northwell Health
state: New York
city: New York
country: United States
facility: New York Eye and Ear of Mount Sinai
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Bend
country: United States
facility: Central Oregon ENT
state: Oregon
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: Duke University
name: Sherri Smith, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.