Clinical trial NCT06731660: Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children
Official title: Effect of Education and Feedback, Wispr Digital Otoscope, or Both on Antibiotic Prescribing Patterns for Otitis Media in Young Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Otitis Media
Antimicrobial Stewardship
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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.
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in OMTI
timeFrame: 3 months
Secondary outcomes:
measure: Change in overall antibiotic courses prescribed
timeFrame: 3 months
measure: Change in overall prescribed antibiotic days
timeFrame: 3 months
measure: Clinician confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscope
timeFrame: 3 months
Other outcomes:
measure: Return respiratory illness visits within 7 days (balancing measure)
timeFrame: 3 months
Locations:
city: Wellesley
country: United States
facility: Pediatric Physicians' Organization at Children's
state: Massachusetts
Study officials:
affiliation: Pediatric Physicians' Organization at Children's
name: Louis Vernacchio, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: