Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children
May 21, 2026 updated by: Louis Vernacchio, Boston Children's Hospital
Effect of Education and Feedback, Wispr Digital Otoscope, or Both on Antibiotic Prescribing Patterns for Otitis Media in Young Children
Randomized controlled trial involving 40 pediatric primary care clinicians with high rates of diagnosing and treating middle ear infections.
Ten enrolled clinicians will be randomly assigned to each of 4 arms for a three-month trial: 1) personalized education and feedback about proper ear infection diagnosis; 2) use of a digital otoscope; 3) both education and feedback plus use of a digital otoscope; 4) control (no intervention).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Randomized controlled trial involving 40 pediatric primary care clinicians with rates of otitis media diagnosis and antibiotic prescribing in the top quartile of the entire clinician population of the Pediatric Physicians' Organization at Children's over the previous 12 months who consent to enroll in the trial after direct outreach from the study team.
Ten enrolled clinicians will be randomly assigned to each of 4 arms for a three-month intervention period: 1) personalized education and feedback about proper otitis media diagnosis following criteria from the American Academy of Pediatrics; 2) use of the Wispr digital otoscope; 3) both education and feedback plus use of the Wispr digital otoscope; 4) control (no intervention).
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Wellesley, Massachusetts, United States, 02115
- Pediatric Physicians' Organization at Children's
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pediatric primary care clinicians from the Pediatric Physicians' Organization at Children's with an Otitis Media Treatment Index for the previous 12 months in the top quartile of all Pediatric Physicians' Organization at Children's clinicians with at least 100 qualifying encounters in the year
Exclusion Criteria:
- Currently using any digital otoscope
- More than one other clinician from the same practice participating in the trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
Control arm, no intervention
|
|
|
Experimental: Education with personalized performance feedback
Education about proper otitis media diagnosis following criteria from the American Academy of Pediatrics with personalized performance feedback on otitis media diagnosis and treatment rates delivered via email
|
Education about proper otitis media diagnosis following criteria from the American Academy of Pediatrics with personalized performance feedback on otitis media diagnosis and treatment rates delivered via email
Other Names:
|
|
Experimental: Use of digital otoscope
Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope
|
Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope
|
|
Experimental: Education with personalized performance feedback plus use of a digital otoscope
Education about proper otitis media diagnosis following criteria from the American Academy of Pediatrics with personalized performance feedback on otitis media diagnosis and treatment rates delivered via email plus use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope
|
Education about proper otitis media diagnosis following criteria from the American Academy of Pediatrics with personalized performance feedback on otitis media diagnosis and treatment rates delivered via email
Other Names:
Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in OMTI
Time Frame: 3 months
|
Proportion of encounters in children 6-59 months of age with any respiratory diagnosis who are diagnosed with otitis media and treated with a systemic antibiotic.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in overall antibiotic courses prescribed
Time Frame: 3 months
|
Courses of systemic antibiotics per 1000 children per year among children 6-59 months of age.
|
3 months
|
|
Change in overall prescribed antibiotic days
Time Frame: 3 months
|
Total days of systemic antibiotics per 1000 children per year among children 6-59 months of age.
|
3 months
|
|
Clinician confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscope
Time Frame: 3 months
|
Clinician responses to a pre- and post-intervention surveys regarding confidence in diagnosing otitis media and satisfaction with digital versus traditional otoscope.
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return respiratory illness visits within 7 days (balancing measure)
Time Frame: 3 months
|
Proportion of patients with an index encounter with respiratory diagnosis who return to the primary care office for a visit with a respiratory diagnosis within 7 days of the index visit.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Louis Vernacchio, MD, MSc, Pediatric Physicians' Organization at Children's
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2025
Primary Completion (Actual)
April 30, 2025
Study Completion (Actual)
October 31, 2025
Study Registration Dates
First Submitted
December 5, 2024
First Submitted That Met QC Criteria
December 9, 2024
First Posted (Actual)
December 12, 2024
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 21, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00049513
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Electronic health record data use for the study are property of the individual practices and may not be shard publicly without their expressed permission.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.