Addressing Barriers to Adult Hearing Healthcare
- Conditions
- Hearing LossGeriatric Disorder
- Interventions
- Other: Tele-HSOther: PCP encouragement
- Registration Number
- NCT02928107
- Lead Sponsor
- Duke University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1146
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCP Encouragement, At-Home Tele-HS Tele-HS Subjects receives encouragement from primary care provider (PCP) or hearing screening, printed materials and access to at-home Tele-HS. PCP Encouragement, At-Home Tele-HS PCP encouragement Subjects receives encouragement from primary care provider (PCP) or hearing screening, printed materials and access to at-home Tele-HS. At-Home Telephone Screening (Tele-HS) Tele-HS Subjects receive printed educational materials about hearing loss and access to at-home Tele-HS PCP Encouragement, In-Office Tele-HS Tele-HS Subjects receives PCP encouragement for hearing screening, printed materials and access to Tele-HS while in clinic. PCP Encouragement, In-Office Tele-HS PCP encouragement Subjects receives PCP encouragement for hearing screening, printed materials and access to Tele-HS while in clinic.
- Primary Outcome Measures
Name Time Method Completion of Tele-HS screen 2 months of PCP appointment (day 1) The proportion (%) of subjects in Groups 1 and 2 who take the test will be compared to those in Group 3.
Medical conditions for which the FDA requires physician evaluation prior to hearing aid fitting 1 day (following completion of Red Flag questionnaires by patient, audiologist and medical provider) 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)
- Secondary Outcome Measures
Name Time Method Scheduling of follow-up audiological testing 4 months of date of Tele-HS 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.
Completion of follow-up audiological testing 4 months of date of Tele-HS 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.
Completion of plan for appropriate hearing loss intervention, if applicable 4 months of date of Tele-HS 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.
Trial Locations
- Locations (6)
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, 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
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Central Oregon ENT
🇺🇸Bend, Oregon, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States