Digital Otoscopy for Ear Infections
(Wispr 2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Louis Vernacchio, MD, MSc
Principal Investigator
Boston Children's Hospital
Are You a Good Fit for This Trial?
This trial is for pediatric primary care practices in Massachusetts. It focuses on young children with ear infections, specifically acute otitis media. The goal is to see if using digital otoscopes improves diagnosis and treatment compared to standard methods.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Run-in Training
Clinicians in intervention practices attend training sessions on the use of digital otoscopy
Data Collection
Data collection period to analyze the difference in OM Treatment Index (OMTI) and other secondary outcomes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Digital Otoscope
Trial Overview
The study tests the effectiveness of digital otoscopes (Wispr Digital Otoscope) against traditional ones in diagnosing and treating ear infections. Practices are split into two groups: one uses the new device after training, while the other continues with standard care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope
No intervention - standard otoscopy to be used
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor
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