Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children (Wispr 2)

Boston Children's Hospital

Status: Begins enrollment this month

Conditions: Otitis Media; Antimicrobial Stewardship

Treatments: Device: Device: Digital Otoscope

Study type: Interventional

Funder types: Other

Identifiers

NCT07328555

PPOC_Wispr 2

Details and patient eligibility

About

Randomized controlled trial involving 4 pediatric primary care practices in Massachusetts. Practices will be stratified by their OM diagnosis and treatment rate, with two practices randomly assigned to the intervention arm and two to the control arm.

For practices randomized to the intervention arm, their offices will be equipped with digital otoscopes (Wispr Digital Otoscope, WiscMed) in each exam room in place of traditional otoscopes. Clinicians in intervention practices will attend a two-hour initial training session on the use of digital otoscopy followed by two one-hour follow-up sessions held over a two-month run-in period prior to the study start to review best practices and troubleshoot any difficulties adapting to the new technology.

Upon completion of the run-in training period, a six-month data collection period will begin. The primary outcome will consist of a difference-in-difference analysis comparing the difference in the OM Treatment Index (OMTI) from the baseline period (October 1 through March 31, 2025) to the intervention period (October 1 through March 31, 2026) between the intervention practices and the control practices. The OMTI is a measure of the rate of diagnosis and antibiotic treatment of OM, specifically calculated as the number of cases with an OM diagnosis and systemic antibiotic prescribed divided by the number of visits with a diagnosis of any acute respiratory tract illness.

Secondary outcomes include analogous difference-in-difference comparisons of: 1) overall antibiotic courses prescribed; 2) overall days of antibiotics prescribed; and 3) a balancing measure of the rate of return visits with any acute respiratory tract illness diagnosis within 7 days of an index visit. Additionally, clinicians will be surveyed to assess confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscopy.

To incentivize participation, practices randomized to the control arm will be loaned digital otoscopes to use for six months at the conclusion of the clinical trial.

Enrollment: 36 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. PPOC practices with 4-9 patient exam rooms, willing to commit to using digital otoscopy for 6 months.
2. Not currently using digital otoscopy.
3. Not involved in the network's previous digital otoscopy study

Exclusion criteria

• Currently using any digital otoscope

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Experimental: Digital Otoscopy

Experimental group

Description:

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

Treatment:

Device: Device: Digital Otoscope

No intervention: Control

No Intervention group

Description:

No intervention - standard otoscopy to be used