Addressing Barriers to Adult Hearing Healthcare
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 65 - 75 |
| Updated: | 11/11/2018 |
| Start Date: | October 31, 2016 |
| End Date: | January 2021 |
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 to 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. The ultimate goal is to provide information to
implement changes in health care policy to facilitate accessible and affordable hearing
health care.
This project will compare implementation of three PCP-based hearing screening strategies that
include progressive levels of PCP time and guidance to complete telephone-based hearing
screening.Those who fail 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). Adults between the ages of 65-75 years old who are being seen for a routine
appointment at a participating Duke primary care site may be eligible to participate.
The primary outcome measure will be the proportion of subjects in Groups 1 and 2 who dial the
phone number and complete the test at or within two months of their PCP visit, relative to
Group 3.
Secondary outcome measures will be 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. Physical exams and procedures associated with this study present no
significant risk to the participant.These are conducted routinely in the clinical
setting.There is the potential for loss of confidentiality.
practices for adults between the ages of 65-75, and to 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. The ultimate goal is to provide information to
implement changes in health care policy to facilitate accessible and affordable hearing
health care.
This project will compare implementation of three PCP-based hearing screening strategies that
include progressive levels of PCP time and guidance to complete telephone-based hearing
screening.Those who fail 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). Adults between the ages of 65-75 years old who are being seen for a routine
appointment at a participating Duke primary care site may be eligible to participate.
The primary outcome measure will be the proportion of subjects in Groups 1 and 2 who dial the
phone number and complete the test at or within two months of their PCP visit, relative to
Group 3.
Secondary outcome measures will be 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. Physical exams and procedures associated with this study present no
significant risk to the participant.These are conducted routinely in the clinical
setting.There is the potential for loss of confidentiality.
This project will compare implementation of three PCP-based hearing screening strategies that
include progressive levels of PCP time and guidance to complete telephone-based hearing
screening. Those who fail 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). Adults between the ages of 65-75 years old who are being seen for a routine
appointment at a participating Duke primary care site may be eligible to participate.
The primary outcome measure will be the proportion of subjects in Groups 1 and 2 who dial the
phone number and complete the test at or within two months of their PCP visit, relative to
Group 3.
Secondary outcome measures will be 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.
include progressive levels of PCP time and guidance to complete telephone-based hearing
screening. Those who fail 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). Adults between the ages of 65-75 years old who are being seen for a routine
appointment at a participating Duke primary care site may be eligible to participate.
The primary outcome measure will be the proportion of subjects in Groups 1 and 2 who dial the
phone number and complete the test at or within two months of their PCP visit, relative to
Group 3.
Secondary outcome measures will be 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.
Inclusion Criteria:
- 65-75 years of age (stratified into equal numbers in age groups 65-70 and 71-75)
- 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
We found this trial at
1
site
40 Duke Medicine Circle
Durham, North Carolina 27710
Durham, North Carolina 27710
Phone: 919-684-6968
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