Early Auditory Referral in Primary Care (EAR-PC)
Early Auditory Referral in Primary Care (EAR-PC)
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Anticipated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48105
- Dominos Farms Family Medicine
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Chelsea, Michigan, United States, 48118
- Chelsea Family Medicine
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Dexter, Michigan, United States, 48130
- Dexter Health Center
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Livonia, Michigan, United States, 48152
- Livonia Health Center
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Rochester Hills, Michigan, United States, 48307
- Beaumont Rochester Hills Family Physicians
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Roseville, Michigan, United States, 48066
- Beaumont East Area Family Practice
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Saint Clair Shores, Michigan, United States, 48080
- Beaumont Shorepointe Family Physicians
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Saint Clair Shores, Michigan, United States, 48081
- Beaumont Family Practice
-
Washington, Michigan, United States, 48095
- Clearwater Family Medicine
-
Ypsilanti, Michigan, United States, 48198
- Ypsilanti Health Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
-55 years or older, doesn't have a known hearing loss on their problem summary list (found in the electronic health record), doesn't already have an open referral to audiology in their chart, and has an encounter with a provider at a participating Family Medicine clinic.
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: Single-Arm, Non-Randomized, Stepped Wedge
All patients who meet the inclusion criteria will receive the same intervention.
|
A Best Practice Alert, or BPA, was created in the electronic medical record system, which fires when patients meet the inclusion criteria.
It reminds providers to ask their patients if they think have a hearing loss and allows them to respond as needed (refer to audiology, add hearing loss to the problem summary list, or dismiss for one year).
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increase in Screening Referrals for Hearing Testing of Patients at High Risk for Hearing Loss
Time Frame: Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.
|
Baseline data on providers and the clinics will be compared to post-intervention data to determine if hearing loss screening referrals improved; Investigators will also do a step-wedged analysis to look at differences between clinics that have gone live with the BPA and those who have not yet gone live.
|
Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Increase in identification of patients with hearing loss
Time Frame: Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.
|
Baseline data on providers will be compared to post-intervention data to determine if the percentage of patients with hearing loss on the problem lists is approaching accepted population rates for this age group
|
Analysis will be done 3 months after data collection completion to allow time for patients to follow up with audiology.
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Philip Zazove, MD, University of Michigan
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- HUM00082363
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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