Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children
NCT ID: NCT07328555
Last Updated: 2026-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
36 participants
INTERVENTIONAL
2026-03-01
2027-09-30
Brief Summary
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For practices randomized to the intervention arm, their offices will be equipped with digital otoscopes (Wispr Digital Otoscope, WiscMed) in each exam room in place of traditional otoscopes. Clinicians in intervention practices will attend a two-hour initial training session on the use of digital otoscopy followed by two one-hour follow-up sessions held over a two-month run-in period prior to the study start to review best practices and troubleshoot any difficulties adapting to the new technology.
Upon completion of the run-in training period, a six-month data collection period will begin. The primary outcome will consist of a difference-in-difference analysis comparing the difference in the OM Treatment Index (OMTI) from the baseline period (October 1 through March 31, 2025) to the intervention period (October 1 through March 31, 2026) between the intervention practices and the control practices. The OMTI is a measure of the rate of diagnosis and antibiotic treatment of OM, specifically calculated as the number of cases with an OM diagnosis and systemic antibiotic prescribed divided by the number of visits with a diagnosis of any acute respiratory tract illness.
Secondary outcomes include analogous difference-in-difference comparisons of: 1) overall antibiotic courses prescribed; 2) overall days of antibiotics prescribed; and 3) a balancing measure of the rate of return visits with any acute respiratory tract illness diagnosis within 7 days of an index visit. Additionally, clinicians will be surveyed to assess confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscopy.
To incentivize participation, practices randomized to the control arm will be loaned digital otoscopes to use for six months at the conclusion of the clinical trial.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Two will receive the intervention (digital otoscopy)
* Two will not receive an intervention (control)
DIAGNOSTIC
NONE
Study Groups
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Experimental: Digital Otoscopy
Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope
Device: Digital Otoscope
Use of the Wispr digital otoscope to diagnose otitis media in place of a standard visual otoscope
No intervention: Control
No intervention - standard otoscopy to be used
No interventions assigned to this group
Interventions
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Device: Digital Otoscope
Use of the Wispr digital otoscope to diagnose otitis media in place of a standard visual otoscope
Eligibility Criteria
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Inclusion Criteria
2. Not currently using digital otoscopy.
3. Not involved in the network's previous digital otoscopy study
Exclusion Criteria
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Jon Hatoun
Director of Data Analytics
Principal Investigators
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Louis Vernacchio, MD, MSc
Role: STUDY_DIRECTOR
Boston Children's Hospital
Locations
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Pediatric Physicians' Organization at Children's
Wellesley, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PPOC_Wispr 2
Identifier Type: -
Identifier Source: org_study_id
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