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Completed

NCT Number: NCT06731660

Digital Otoscope Versus Education and Feedback 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).

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Key information

Conditions

Otitis Media Antimicrobial Stewardship Ear Diseases Otitis Otorhinolaryngologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Physicians' Organization at Children's

Wellesley, Massachusetts, 02115, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education with personalized performance feedback

Other

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: Education and feedback

Use of digital otoscope

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 12, 2024
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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