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NCT Number: NCT07328555

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Otitis Media Antimicrobial Stewardship Ear Diseases Otitis Otorhinolaryngologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Physicians' Organization at Children's

Wellesley, Massachusetts, 02481, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Currently using any digital otoscope

Treatment and study plan

Device: Digital Otoscope

Device

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

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).

    Time frame: 6 months

    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.

Secondary outcomes

  1. Change in overall antibiotic courses prescribed

    Time frame: 6 months

    Difference-in-differences analysis of the change in the overall number of antibiotic courses prescribed per 100 encounters (excluding well visits) comparing the intervention arm to the control arm, using logistic regression with nested random effect at the practice level.

  2. Change in overall prescribed antibiotic days

    Time frame: 6 months

    Difference-in-differences analysis of the change in the overall number of prescribed antibiotic days per 100 encounters (excluding well visits) comparing the intervention arm to the control arm, using logistic regression with nested random effect at the practice level.

  3. Return acute respiratory tract illness visits

    Time frame: Within 7 days of index visit

    Comparison between intervention and control arm of the proportion of patients with an index visit with an acute respiratory tract illness diagnosis who return to the PCP for a visit with an acute respiratory tract illness diagnosis within 7 days of index

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Official study title

Site Randomized Clinical Trial of the Effect of Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children

Acronym: Wispr 2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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