Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children

NCT07328555 | Not Yet Recruiting FDA Device

• 1 other identifier: PPOC_Wispr 2
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Otitis Media; Antimicrobial Stewardship

Keywords

Otoscopy

Outcome Measures

Primary Outcomes (1)

• Change in proportion of visits with any respiratory diagnosis in which otitis media is diagnosed and treated with antibiotics (referred to as the otitis media treatment index - OMTI).

  Difference-in-differences analysis of the change in OMTI from baseline to the intervention period comparing the intervention arm to the control arm using logistic regression with nested random effect at the practice level.

  6 months

Secondary Outcomes (3)

• Change in overall antibiotic courses prescribed

  6 months

• Change in overall prescribed antibiotic days

  6 months

• Return acute respiratory tract illness visits

  Within 7 days of index visit

Study Arms (2)

Experimental: Digital Otoscopy

EXPERIMENTAL

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

Device: Device: Digital Otoscope

No intervention: Control

NO INTERVENTION

No intervention - standard otoscopy to be used

Interventions

Device: Digital Otoscope DEVICE

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

Experimental: Digital Otoscopy

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Currently using any digital otoscope

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Pediatric Physicians' Organization at Children's

Wellesley, Massachusetts, 02481, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Louis Vernacchio, MD, MSc

  Boston Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Jane Gould, MPH

CONTACT

6179191608; jane.bittner@childrens.harvard.edu

Jonathan Hatoun, MD, MPH, MS

CONTACT

6179191608; jonathan.hatoun@childrens.harvard.edu

Study Design

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

Model Details: Four enrolled practices: * Two will receive the intervention (digital otoscopy) * Two will not receive an intervention (control)

Study Record Dates

• First Submitted: January 7, 2026
• First Posted: January 9, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)