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Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children

Effect of Education and Feedback, Wispr Digital Otoscope, or Both on Antibiotic Prescribing Patterns for Otitis Media in Young Children

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06731660
Enrollment
40
Registered
2024-12-12
Start date
2025-01-01
Completion date
2025-10-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antimicrobial Stewardship, Otitis Media

Brief summary

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).

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).

Interventions

OTHEREducation 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

DEVICEUse of digital otoscope

Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope

Sponsors

Boston Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

2x2 factorial design comparing effect of Wispr digital otoscope, education with performance feedback, both, or neither on diagnosis and antibiotic treatment of otitis media in young children.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in OMTI3 monthsProportion 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.

Secondary

MeasureTime frameDescription
Change in overall antibiotic courses prescribed3 monthsCourses of systemic antibiotics per 1000 children per year among children 6-59 months of age.
Change in overall prescribed antibiotic days3 monthsTotal days of systemic antibiotics per 1000 children per year among children 6-59 months of age.
Clinician confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscope3 monthsClinician responses to a pre- and post-intervention surveys regarding confidence in diagnosing otitis media and satisfaction with digital versus traditional otoscope.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLouis Vernacchio, MD, MSc

Pediatric Physicians' Organization at Children's

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026