Addressing Barriers to Adult Hearing Healthcare
4 other identifiers
interventional
1,146
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2016
CompletedFirst Posted
Study publicly available on registry
October 10, 2016
CompletedStudy Start
First participant enrolled
October 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 27, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 27, 2021
CompletedNovember 9, 2021
November 1, 2021
4.8 years
October 6, 2016
November 8, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Scheduling of follow-up audiological testing
4 months of date of Tele-HS
Completion of follow-up audiological testing
4 months of date of Tele-HS
Completion of plan for appropriate hearing loss intervention, if applicable
4 months of date of Tele-HS
Other Outcomes (4)
Significance of medical conditions requiring medical evaluation prior to hearing aid fitting
1 day, completion of patient, audiologist and provider questionnaires
Cost to conduct telephone hearing screening in the Primary Care clinic setting
1 day
Attitudes towards hearing loss
2 days
- +1 more other outcomes
Study Arms (4)
At-Home Telephone Screening (Tele-HS)
EXPERIMENTALSubjects receive printed educational materials about hearing loss and access to at-home Tele-HS
PCP Encouragement, At-Home Tele-HS
EXPERIMENTALSubjects receives encouragement from primary care provider (PCP) or hearing screening, printed materials and access to at-home Tele-HS.
PCP Encouragement, In-Office Tele-HS
EXPERIMENTALSubjects receives PCP encouragement for hearing screening, printed materials and access to Tele-HS while in clinic.
CHEER Cohort (non-randomized)
NO INTERVENTIONParticipants 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.
Interventions
Patients will be given information on the Tele-HS and given access to take the screening at home or in-office, depending on arm.
Patients will or will not either receive PCP encouragement to do the Tele-HS.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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:
- 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
- Not between the ages of 65-75
- Current or past hearing aid user
- Prior diagnosis of hearing loss or hearing aid user
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Northwell Health
New Hyde Park, New York, 11040, United States
New York Eye and Ear of Mount Sinai
New York, New York, 10029, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Central Oregon ENT
Bend, Oregon, 97701, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Related Publications (2)
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.
PMID: 35751122DERIVEDBettger 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.
PMID: 32393184DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sherri Smith, PhD
Duke University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2016
First Posted
October 10, 2016
Study Start
October 31, 2016
Primary Completion
August 27, 2021
Study Completion
August 27, 2021
Last Updated
November 9, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- At the end of the study data analysis
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.