Otitis MediaNCT06731660
Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children
A study testing Education with personalized performance feedback and Use of digital otoscope in people with Otitis Media and Antimicrobial Stewardship, run by Boston Children's Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Otitis Media, Antimicrobial Stewardship
- What is being tested?
- Education with personalized performance feedback and Use of digital otoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently using any digital otoscope
- More than one other clinician from the same practice participating in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
Pediatric Physicians' Organization at Children's
Wellesley, Massachusetts, 02115
About this study
Official title: Effect of Education and Feedback, Wispr Digital Otoscope, or Both on Antibiotic Prescribing Patterns for Otitis Media in Young Children
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).
Read the detailed description
Randomized controlled trial involving 40 pediatric primary care clinicians with rates of otitis media diagnosis and antibiotic prescribing in the top quartile of the entire clinician population of the Pediatric Physicians' Organization at Children's over the previous 12 months who consent to enroll in the trial after direct outreach from the study team. Ten enrolled clinicians will be randomly assigned to each of 4 arms for a three-month intervention period: 1) personalized education and feedback about proper otitis media diagnosis following criteria from the American Academy of Pediatrics; 2) use of the Wispr digital otoscope; 3) both education and feedback plus use of the Wispr digital otoscope; 4) control (no intervention).
- Conditions
- Otitis Media, Antimicrobial Stewardship
- Being tested
- Education with personalized performance feedback, Use of digital otoscope
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education with personalized performance feedbackOther
Also called Education and feedback
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
Use of digital otoscopeDevice
Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope
| Study group | Role | What they receive |
|---|---|---|
| Education with personalized performance feedback | Experimental | 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 Receives: Other: Education with personalized performance feedback |
| Use of digital otoscope | Experimental | Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope Receives: Device: Use of digital otoscope |
| Education with personalized performance feedback plus use of a digital otoscope | Experimental | 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 Receives: Other: Education with personalized performance feedback; Device: Use of digital otoscope |
| Control | No intervention | Control arm, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in OMTI
Proportion of encounters in children 6-59 months of age with any respiratory diagnosis who are diagnosed with otitis media and treated with a systemic antibiotic.
Measured: 3 months
Secondary outcomes (3)
Change in overall antibiotic courses prescribed
Courses of systemic antibiotics per 1000 children per year among children 6-59 months of age.
Measured: 3 months
Change in overall prescribed antibiotic days
Total days of systemic antibiotics per 1000 children per year among children 6-59 months of age.
Measured: 3 months
Clinician confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscope
Clinician responses to a pre- and post-intervention surveys regarding confidence in diagnosing otitis media and satisfaction with digital versus traditional otoscope.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2024
- Study start1 Jan 2025
- Primary completion30 Apr 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- 2x2 factorial design comparing effect of Wispr digital otoscope, education with performance feedback, both, or neither on diagnosis and antibiotic treatment of otitis media in young children.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Vernacchio, Boston Children's Hospital
- Investigators
- Louis Vernacchio, MD, MSc, Principal investigator, Pediatric Physicians' Organization at Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06731660
- Sponsor's protocol ID
- P00049513
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Electronic health record data use for the study are property of the individual practices and may not be shard publicly without their expressed permission.
Publications
Hatoun J, Patane LB, Gould JB, Vernacchio L. Feedback with Education versus Digital Otoscopy for Acute Otitis Media Diagnosis and Treatment. J Pediatr. 2026 Aug 4;299:115271. doi: 10.1016/j.jpeds.2026.115271. Online ahead of print.
PubMed 42551729
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Education and Feedback, Wispr Digital Otoscope, or Both on Antibiotic Prescribing Patterns for Otitis Media in Young Children
- ClinicalTrials.gov ID
- NCT06731660
- Acronym / sponsor ID
- P00049513
- Conditions
- Otitis Media, Antimicrobial Stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 12 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Randomized controlled trial involving 40 pediatric primary care clinicians with rates of otitis media diagnosis and antibiotic prescribing in the top quartile of the entire clinician population of the Pediatric Physicians' Organization at Children's over the previous 12 months who consent to enroll in the trial after direct outreach from the study team. Ten enrolled clinicians will be randomly assigned to each of 4 arms for a three-month intervention period: 1) personalized education and feedback about proper otitis media diagnosis following criteria from the American Academy of Pediatrics; 2) use of the Wispr digital otoscope; 3) both education and feedback plus use of the Wispr digital otoscope; 4) control (no intervention).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 2x2 factorial design comparing effect of Wispr digital otoscope, education with performance feedback, both, or neither on diagnosis and antibiotic treatment of otitis media in young children.
| Arm | Type | Receives |
|---|---|---|
| Education with personalized performance feedback | Experimental | Other: Education with personalized performance feedbackEducation 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 |
| Use of digital otoscope | Experimental | Device: Use of digital otoscopeUse of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope |
| Education with personalized performance feedback plus use of a digital otoscope | Experimental | Other: Education with personalized performance feedback, Device: Use of digital otoscopeEducation 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 |
| Control | No intervention | –Control arm, no intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- Currently using any digital otoscope
- More than one other clinician from the same practice participating in the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education with personalized performance feedbackAlso: Education and feedbackEducation 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 | Other | Education with personalized performance feedback, Education with personalized performance feedback plus use of a digital otoscope |
| Use of digital otoscopeUse of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope | Device | Education with personalized performance feedback plus use of a digital otoscope, Use of digital otoscope |
Primary outcome
Change in OMTI
Time frame: 3 months
Proportion of encounters in children 6-59 months of age with any respiratory diagnosis who are diagnosed with otitis media and treated with a systemic antibiotic.
3 secondary outcomes
Change in overall antibiotic courses prescribed
Time frame: 3 months
Change in overall prescribed antibiotic days
Time frame: 3 months
Clinician confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscope
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Derived from this study: PubMed 42551729Hatoun J, Patane LB, Gould JB, Vernacchio L. Feedback with Education versus Digital Otoscopy for Acute Otitis Media Diagnosis and Treatment. J Pediatr. 2026 Aug 4;299:115271. doi: 10.1016/j.jpeds.2026.115271. Online ahead of print.
- Individual participant dataSharing planned: No. Electronic health record data use for the study are property of the individual practices and may not be shard publicly without their expressed permission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louis Vernacchio, MD, MSc principal investigator
Pediatric Physicians' Organization at Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education with personalized performance feedback and Use of digital otoscope in people with Otitis Media and Antimicrobial Stewardship, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in OMTI (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06731660, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.