Hearing LossNCT02928107
Addressing Barriers to Adult Hearing Healthcare
A study testing Tele-HS and PCP encouragement in people with Hearing Loss and Geriatric Disorder, run by Duke University at 6 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 65 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Geriatric Disorder
- What is being tested?
- Tele-HS and PCP encouragement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,146 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Oct 2016to 27 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 75 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
- 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
Who cannot join
- 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:
- Not between the ages of 65-75
- Current or past hearing aid user
- Prior diagnosis of hearing loss or hearing aid user
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
University of Michigan
Ann Arbor, Michigan, 48109
Central Oregon ENT
Bend, Oregon, 97701
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University Medical Center
Durham, North Carolina, 27710
Northwell Health
New Hyde Park, New York, 11040
New York Eye and Ear of Mount Sinai
New York, New York, 10029
About this study
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.
Read the 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.
- Conditions
- Hearing Loss, Geriatric Disorder
- Being tested
- Tele-HS, PCP encouragement
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-HSOther
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 encouragementOther
Patients will or will not either receive PCP encouragement to do the Tele-HS.
| Study group | Role | What they receive |
|---|---|---|
| At-Home Telephone Screening (Tele-HS) | Experimental | Subjects receive printed educational materials about hearing loss and access to at-home Tele-HS Receives: Other: Tele-HS |
| PCP Encouragement, At-Home Tele-HS | Experimental | Subjects receives encouragement from primary care provider (PCP) or hearing screening, printed materials and access to at-home Tele-HS. Receives: Other: Tele-HS; Other: PCP encouragement |
| PCP Encouragement, In-Office Tele-HS | Experimental | Subjects receives PCP encouragement for hearing screening, printed materials and access to Tele-HS while in clinic. Receives: Other: Tele-HS; Other: PCP encouragement |
| CHEER Cohort (non-randomized) | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 1 day (following completion of Red Flag questionnaires by patient, audiologist and medical provider)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 4 months of date of Tele-HS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start31 Oct 2016
- Primary completion27 Aug 2021
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Sherri Smith, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928107
- Sponsor's protocol ID
- Pro00070422
- Other IDs
- R21DC015003-01, R33DC015003, Pro00086182
- Status last verified
- Nov 2021
- First submitted
- 6 Oct 2016
- Last updated
- 9 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 35751122Bettger 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.
PubMed 32393184
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Barriers to Adult Hearing Healthcare
- ClinicalTrials.gov ID
- NCT02928107
- Acronym / sponsor ID
- Pro00070422
- Conditions
- Hearing Loss, Geriatric Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,146 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 27 Aug 2021 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| At-Home Telephone Screening (Tele-HS) | Experimental | Other: Tele-HSSubjects receive printed educational materials about hearing loss and access to at-home Tele-HS |
| PCP Encouragement, At-Home Tele-HS | Experimental | Other: Tele-HS, Other: PCP encouragementSubjects 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 | Experimental | Other: Tele-HS, Other: PCP encouragementSubjects receives PCP encouragement for hearing screening, printed materials and access to Tele-HS while in clinic. |
| CHEER Cohort (non-randomized) | No intervention | –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. |
Who may qualify
- Ages
- 65 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- 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
- 65-75 years of age
- Being seen by an OHNS/ENT provider for a complaint of hearing loss.
Key exclusion criteria (8 listed)
- 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
- Not between the ages of 65-75
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-HSPatients will be given information on the Tele-HS and given access to take the screening at home or in-office, depending on arm. | Other | At-Home Telephone Screening (Tele-HS), PCP Encouragement, At-Home Tele-HS, PCP Encouragement, In-Office Tele-HS |
| PCP encouragementPatients will or will not either receive PCP encouragement to do the Tele-HS. | Other | PCP Encouragement, At-Home Tele-HS, PCP Encouragement, In-Office Tele-HS |
Primary outcome
Completion of Tele-HS screen
Time frame: 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
Time frame: 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)
3 secondary outcomes
Scheduling of follow-up audiological testing
Time frame: 4 months of date of Tele-HS
Completion of follow-up audiological testing
Time frame: 4 months of date of Tele-HS
Completion of plan for appropriate hearing loss intervention, if applicable
Time frame: 4 months of date of Tele-HS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2021.
- Derived from this study: PubMed 35751122Dubno 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.
- Derived from this study: PubMed 32393184Bettger 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sherri Smith, PhD principal investigator
Duke University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-HS and PCP encouragement in people with Hearing Loss and Geriatric Disorder, run by Duke University at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Tele-HS screen (time frame: 2 months of PCP appointment (day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02928107, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2021.