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

NCT06731660 | Active Not Recruiting

• 1 other identifier: P00049513
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Otitis Media; Antimicrobial Stewardship

Outcome Measures

Primary Outcomes (1)

• Change in OMTI

  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 Outcomes (3)

• Change in overall antibiotic courses prescribed

  3 months

• Change in overall prescribed antibiotic days

  3 months

• Clinician confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscope

  3 months

Other Outcomes (1)

• Return respiratory illness visits within 7 days (balancing measure)

  3 months

Study Arms (4)

Education with personalized performance feedback

EXPERIMENTAL

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: Education with personalized performance feedback

Use of digital otoscope

EXPERIMENTAL

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

Device: Use of digital otoscope

Education with personalized performance feedback plus use of a digital otoscope

EXPERIMENTAL

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

Other: Education with personalized performance feedback; Device: Use of digital otoscope

Control

NO INTERVENTION

Control arm, no intervention

Interventions

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

Also known as: Education and feedback

Education with personalized performance feedback; Education with personalized performance feedback plus use of a digital otoscope

Use of digital otoscope DEVICE

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

Education with personalized performance feedback plus use of a digital otoscope; Use of digital otoscope

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Currently using any digital otoscope
• More than one other clinician from the same practice participating in the trial

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Pediatric Physicians' Organization at Children's

Wellesley, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Otitis Media

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Louis Vernacchio, MD, MSc

  Pediatric Physicians' Organization at Children's

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Model Details: 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.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 12, 2024
• Study Start: January 1, 2025
• Primary Completion: April 30, 2025
• Study Completion: January 31, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)