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

NCT ID: NCT06731660

Last Updated: 2024-12-12

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-10-31

Brief Summary

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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

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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).

Conditions

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Otitis Media Antimicrobial Stewardship

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Education 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

Group Type EXPERIMENTAL

Education with personalized performance feedback

Intervention Type 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

Use of digital otoscope

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

Group Type EXPERIMENTAL

Use of digital otoscope

Intervention Type 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

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

Group Type EXPERIMENTAL

Education with personalized performance feedback

Intervention Type 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

Use of digital otoscope

Intervention Type DEVICE

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

Control

Control arm, no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Education 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

Intervention Type OTHER

Use of digital otoscope

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

Intervention Type DEVICE

Other Intervention Names

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Education and feedback

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boston Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Louis Vernacchio

Director of Research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Louis Vernacchio, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Pediatric Physicians' Organization at Children's

Locations

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Pediatric Physicians' Organization at Children's

Wellesley, Massachusetts, United States

Site Status

Countries

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United States

Central Contacts

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Jane Gould, MPH

Role: CONTACT

Phone: 617-919-4073

Email: [email protected]

Louis Vernacchio, MD, MSc

Role: CONTACT

Phone: 617-919-4073

Email: [email protected]

Facility Contacts

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Jane Gould, MPH

Role: primary

Louis Vernacchio, MD, MSc

Role: backup

Louis Vernacchio, MD, MSc

Role: backup

Jonathan Hatoun, MD, MPH, MS

Role: backup

Other Identifiers

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P00049513

Identifier Type: -

Identifier Source: org_study_id