Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 5:34 AM
Study NCT ID:
NCT06731660
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-12-12
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004522', 'term': 'Educational Status'}], 'ancestors': [{'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2024-12-05', 'studyFirstSubmitQcDate': '2024-12-09', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Return respiratory illness visits within 7 days (balancing measure)', 'timeFrame': '3 months', 'description': 'Proportion of patients with an index encounter with respiratory diagnosis who return to the primary care office for a visit with a respiratory diagnosis within 7 days of the index visit.'}], 'primaryOutcomes': [{'measure': 'Change in OMTI', 'timeFrame': '3 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in overall antibiotic courses prescribed', 'timeFrame': '3 months', 'description': 'Courses of systemic antibiotics per 1000 children per year among children 6-59 months of age.'}, {'measure': 'Change in overall prescribed antibiotic days', 'timeFrame': '3 months', 'description': 'Total days of systemic antibiotics per 1000 children per year among children 6-59 months of age.'}, {'measure': 'Clinician confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscope', 'timeFrame': '3 months', 'description': 'Clinician responses to a pre- and post-intervention surveys regarding confidence in diagnosing otitis media and satisfaction with digital versus traditional otoscope.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Otitis Media', 'Antimicrobial Stewardship']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* Currently using any digital otoscope\n* More than one other clinician from the same practice participating in the trial"}, 'identificationModule': {'nctId': 'NCT06731660', 'briefTitle': 'Digital Otoscope Versus Education and Feedback for Otitis Media in Young Children', 'organization': {'class': 'OTHER', 'fullName': "Boston Children's Hospital"}, 'officialTitle': 'Effect of Education and Feedback, Wispr Digital Otoscope, or Both on Antibiotic Prescribing Patterns for Otitis Media in Young Children', 'orgStudyIdInfo': {'id': 'P00049513'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Education with personalized performance feedback', 'description': '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', 'interventionNames': ['Other: Education with personalized performance feedback']}, {'type': 'EXPERIMENTAL', 'label': 'Use of digital otoscope', 'description': 'Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope', 'interventionNames': ['Device: Use of digital otoscope']}, {'type': 'EXPERIMENTAL', 'label': 'Education with personalized performance feedback plus use of a digital otoscope', 'description': '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', 'interventionNames': ['Other: Education with personalized performance feedback', 'Device: Use of digital otoscope']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control arm, no intervention'}], 'interventions': [{'name': 'Education with personalized performance feedback', 'type': 'OTHER', 'otherNames': ['Education and feedback'], 'description': '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', 'armGroupLabels': ['Education with personalized performance feedback', 'Education with personalized performance feedback plus use of a digital otoscope']}, {'name': 'Use of digital otoscope', 'type': 'DEVICE', 'description': 'Use of the Wispr digital otoscope to diagnose otitis media in place of a traditional visual otoscope', 'armGroupLabels': ['Education with personalized performance feedback plus use of a digital otoscope', 'Use of digital otoscope']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02115', 'city': 'Wellesley', 'state': 'Massachusetts', 'country': 'United States', 'contacts': [{'name': 'Jane Gould, MPH', 'role': 'CONTACT', 'email': 'PPOCResearch@childrens.harvard.edu', 'phone': '617-919-4074'}, {'name': 'Louis Vernacchio, MD, MSc', 'role': 'CONTACT', 'email': 'louis.vernacchio@childrens.harvard.edu', 'phone': '617-919-4074'}, {'name': 'Louis Vernacchio, MD, MSc', 'role': 'CONTACT'}, {'name': 'Jonathan Hatoun, MD, MPH, MS', 'role': 'CONTACT'}], 'facility': "Pediatric Physicians' Organization at Children's", 'geoPoint': {'lat': 42.29649, 'lon': -71.29256}}], 'centralContacts': [{'name': 'Jane Gould, MPH', 'role': 'CONTACT', 'email': 'jane.bittner@childrens.harvard.edu', 'phone': '617-919-4073'}, {'name': 'Louis Vernacchio, MD, MSc', 'role': 'CONTACT', 'email': 'louis.vernacchio@childrens.harvard.edu', 'phone': '617-919-4073'}], 'overallOfficials': [{'name': 'Louis Vernacchio, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Pediatric Physicians' Organization at Children's"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Electronic health record data use for the study are property of the individual practices and may not be shard publicly without their expressed permission.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Boston Children's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Research', 'investigatorFullName': 'Louis Vernacchio', 'investigatorAffiliation': "Boston Children's Hospital"}}}}