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Behavioural Intervention
Digital Otoscope vs Education for Ear Infections
N/A
Waitlist Available
Led By Louis Vernacchio, MD, MSc
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group
Summary
This trial will involve 40 pediatric primary care clinicians who frequently diagnose and treat middle ear infections. They will be split into 4 groups, with 10 clinicians in each group. Each group will receive
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves educational tools and diagnostic equipment rather than medications, there are no direct side effects like those associated with drugs. Indirect effects may include changes in clinical practice patterns.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in OMTI
Secondary study objectives
Change in overall antibiotic courses prescribed
Change in overall prescribed antibiotic days
Clinician confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscope
Other study objectives
Return respiratory illness visits within 7 days (balancing measure)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Use of digital otoscopeExperimental Treatment1 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 otoscopeExperimental Treatment2 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 feedbackExperimental Treatment1 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: ControlActive Control1 Intervention
Control arm, no intervention
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Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
789 Previous Clinical Trials
5,582,866 Total Patients Enrolled
Louis Vernacchio, MD, MScPrincipal InvestigatorPediatric Physicians' Organization at Children's
1 Previous Clinical Trials
326 Total Patients Enrolled