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

Not Applicable

Not yet recruiting

• Conditions: Otitis Media; Antimicrobial Stewardship

• Registration Number: NCT06731660
• Lead Sponsor: Boston Children's Hospital

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).

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-12
• Last Update Posted: 2024-12-12
• Study Start: 2025-01-01
• Primary Completion: 2025-04-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in OMTI	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.

Secondary Outcome Measures

Name	Time	Method
Change in overall antibiotic courses prescribed	3 months	Courses of systemic antibiotics per 1000 children per year among children 6-59 months of age.
Change in overall prescribed antibiotic days	3 months	Total 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 otoscope	3 months	Clinician responses to a pre- and post-intervention surveys regarding confidence in diagnosing otitis media and satisfaction with digital versus traditional otoscope.

Trial Locations

Locations (1)

Pediatric Physicians' Organization at Children's; 🇺🇸 Wellesley, Massachusetts, United States