Digital Otoscope vs Education for Ear Infections

Overseen By Louis Vernacchio, MD, MSc

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Using digital otoscope, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment Education with personalized performance feedback and use of digital otoscope for ear infections?

Research shows that using digital otoscopes can improve the accuracy of ear exams and boost the confidence of medical trainees. This suggests that digital otoscopes might help in better diagnosing ear infections, potentially reducing unnecessary antibiotic prescriptions. ^{1 2 3 4 5}

Is the use of digital otoscopes safe for humans?

The research does not report any safety concerns related to the use of digital otoscopes in humans. ^{1 3 4 6 7}

How does the digital otoscope treatment differ from other treatments for ear infections?

The digital otoscope treatment is unique because it allows both the trainee and supervisor to view the eardrum simultaneously, improving diagnostic accuracy and confidence compared to traditional otoscopes. This approach also reduces the need for repeat examinations and may lead to more appropriate antibiotic use. ^{1 2 3 8 9}

What is the purpose of this trial?

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).

Research Team

Louis Vernacchio, MD, MSc

Principal Investigator

Pediatric Physicians' Organization at Children's

Eligibility Criteria

This trial is for pediatric primary care clinicians with a high frequency of diagnosing and treating middle ear infections in young children. Specific eligibility criteria are not provided, but typically participants would be active healthcare professionals in pediatrics.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Clinicians are randomly assigned to one of four arms: education and feedback, use of digital otoscope, both interventions, or control, for a three-month period

3 months

Follow-up

Participants are monitored for changes in antibiotic prescribing patterns and clinician confidence post-intervention

4 weeks

Treatment Details

Interventions

• Education with personalized performance feedback
• Use of digital otoscope

Trial Overview The study is testing if personalized education with feedback or the use of a digital otoscope can improve the diagnosis and treatment of ear infections. Clinicians will be randomly placed into one of four groups: education only, digital otoscope only, both interventions, or no intervention.

Participant Groups

Group I: Use of digital otoscope Experimental Treatment 1 Intervention

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

Group II: Education with personalized performance feedback plus use of a digital otoscope Experimental Treatment 2 Interventions

Education about proper otitis media diagnosis following criteria from the American Academy of Pediatrics with personalized performance feedback on otitis media diagnosis and treatment rates delivered via email plus use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope

Group III: Education with personalized performance feedback Experimental Treatment 1 Intervention

Education about proper otitis media diagnosis following criteria from the American Academy of Pediatrics with personalized performance feedback on otitis media diagnosis and treatment rates delivered via email

Group IV: Control Active Control 1 Intervention

Control arm, no intervention

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Video otoscopy: bringing otoscopy out of the "black box". [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Utilization of Video Otoscopes for Otoscopy Skills Training of Third Year Medical Students. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Evaluation of digital otoscopy in pediatric patients: A prospective randomized controlled clinical trial. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

Utility of a smartphone-enabled otoscope in the instruction of otoscopy and middle ear anatomy. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

A randomised trial to assess the educational benefit of a smartphone otoscope in undergraduate medical training. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Assessment of Pediatric Residents' Comfort Level With CellScope Oto to Examine Pediatric Ear Exams. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Clinical consequences of feedback on ear surgery: the continuous recording of adverse events and complications with regard to reducing the number of surgeons who perform otosclerosis surgery. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Evaluation of a Web-Based Module and an Otoscopy Simulator in Teaching Ear Disease. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

Endoscopic ear examination improves self-reported confidence in ear examination skills among undergraduate medical students compared with handheld otoscopy. [2022]