[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657959":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":47,"studyPopulation":38,"armGroups":48,"interventions":61,"overallOfficials":69,"centralContacts":73,"locations":78,"responsibleParty":104,"collaborators":107,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":113,"sex":119,"minAge":120,"maxAge":121,"enrollmentInfo":122,"targetDuration":38,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":135,"overallStatus":140,"whyStopped":38,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"University of Pittsburgh","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":38},[9,13],{"measure":10,"description":11,"timeFrame":12},"Number of ARTI antibiotics","Number of antibiotic courses prescribed for acute respiratory tract infections (ARTIs) per participant from enrollment through 12 months after enrollment. An antibiotic course is defined according to the study protocol. This is the primary outcome for the first pre-specified analysis.","From enrollment through 12 months after enrollment",{"measure":14,"description":15,"timeFrame":12},"Total annual healthcare costs from the payer perspective","Total healthcare costs incurred per participant from the payer perspective from enrollment through 12 months after enrollment, reported in U.S. dollars. This is the primary outcome for the second pre-specified analysis.",[17,20,23,26,29,32,35],{"measure":18,"description":19,"timeFrame":12},"Number of ARTI antibiotic days prescribed","Total number of days of antibiotic therapy prescribed for ARTI per participant from enrollment through 12 months after enrollment. This is a secondary outcome for the first pre-specified analysis.",{"measure":21,"description":22,"timeFrame":12},"Number of ARTI broad-spectrum antibiotic courses","Number of broad-spectrum antibiotic courses prescribed for ARTI per participant from enrollment through 12 months after enrollment. Broad-spectrum antibiotics are defined according to the study protocol. This is a secondary outcome for the first pre-specified analysis.",{"measure":24,"description":25,"timeFrame":12},"Number of total antibiotic courses (any diagnosis)","Number of antibiotic courses prescribed for any diagnosis per participant from enrollment through 12 months after enrollment. This is a secondary outcome for the first pre-specified analysis.",{"measure":27,"description":28,"timeFrame":12},"Number of ARTI visits overall and by site (ED, urgent care, primary care)","Number of visits for acute respiratory tract infections (ARTIs) per participant from enrollment through 12 months after enrollment, summarized overall and by visit setting (emergency department, urgent care, and primary care). This is a secondary outcome for the first pre-specified analysis.",{"measure":30,"description":31,"timeFrame":12},"Percentage of ARTI visits resulting in antibiotic prescription","Percentage of ARTI visits resulting in an antibiotic prescription from enrollment through 12 months after enrollment, summarized overall and by visit setting (emergency department, urgent care, and primary care). This is a secondary outcome for the first pre-specified analysis.",{"measure":33,"description":34,"timeFrame":12},"Total annual family out of pocket costs","Total family out-of-pocket healthcare costs per participant from enrollment through 12 months after enrollment, reported in U.S. dollars. This is a secondary outcome for the second pre-specified analysis.",{"measure":36,"description":37,"timeFrame":12},"Total annual costs from the primary care practice perspective","Total healthcare costs from the primary care practice perspective per participant from enrollment through 12 months after enrollment, reported in U.S. dollars. This is a secondary outcome for the second pre-specified analysis.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":38,"primaryPurpose":42,"observationalModel":38,"timePerspective":38,"maskingInfo":43},"RANDOMIZED","PARALLEL","HEALTH_SERVICES_RESEARCH",{"masking":44,"maskingDescription":38,"whoMasked":45},"SINGLE",[46],"OUTCOMES_ASSESSOR","This is an interventional study. In this two-arm randomized controlled trial, randomization will occur stratified by child age at enrollment (6-14 months, 15-23 months) and study site. The trial will be conducted in academic and community pediatric practices. This study includes two prespecified, parallel analyses in the following aims:\n\nAim 1: Assess the impact of tele-otoscope vs. eBook enabled primary care practice (PCP) telemedicine for pediatric ARTIs on antibiotic prescribing and healthcare utilization among young children who have at least one prior episode of AOM.\n\nAim 2: Assess the economic consequences from a payer perspective of providing at-home tele-otoscopes vs. eBooks to young children who have at least a prior episode of AOM.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Tele-Otoscope","EXPERIMENTAL","Children randomized to the experimental arm will receive a tele- otoscope and ear irrigation device (to assist cerumen removal if needed); parents will be trained on the use of these devices. Parents will be asked to download the tele-otoscope app which will allow them to view and record from the tele-otoscope camera. These devices (tele-otoscope and ear irrigation device) are commercially available and their functionality is not being tested in this study.",[54],"Other: Tele-Otoscope Enabled Primary Care",{"label":56,"type":57,"description":58,"interventionNames":59},"eBook","PLACEBO_COMPARATOR","Children randomized to the control arm will receive an eBook on baby and toddler care from the American Academy of Pediatrics. As in prior studies of tele-services, we will provide the eBook as a \"digital placebo.\" Thus, participants in both arms receive an electronic resource, but the eBook has limited content specific to ARTI care, such that it is not expected to significantly influence study outcomes.",[60],"Other: eBook-supported primary care",[62,66],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":38},"Tele-Otoscope Enabled Primary Care","Children randomized to the experimental arm will receive a tele- otoscope and ear irrigation device (to assist cerumen removal if needed); parents will be trained on the use of these devices. Parents will be asked to download the tele-otoscope app which will allow them to view and record from the tele-otoscope camera. These devices (tele-otoscope and ear irrigation device) are commercially available and their functionality is not being tested in this study, which focuses instead on testing the impact of their availability when integrated into primary care telemedicine.",[50],{"type":6,"name":67,"description":58,"armGroupLabels":68,"otherNames":38},"eBook-supported primary care",[56],[70],{"name":71,"affiliation":5,"role":72},"Kristin Ray, MD, MS","PRINCIPAL_INVESTIGATOR",[74],{"name":71,"role":75,"phone":76,"phoneExt":38,"email":77},"CONTACT","412-465-0173‬","knr16@pitt.edu",[79,96],{"facility":80,"status":38,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"UPMC Children's Community Pediatrics","Pittsburgh","Pennsylvania","15213","United States","US",{"type":87,"coordinates":88},"Point",[89,90],-79.99589,40.44062,{"lat":90,"lon":89},[93],{"name":94,"role":75,"phone":76,"phoneExt":38,"email":95},"CCP Research Medical Director","patrick.tate2@chp.edu",{"facility":97,"status":38,"city":81,"state":82,"zip":83,"country":84,"countryCode":85,"cosmosGeoPoint":98,"geoPoint":100,"contacts":101},"UPMC Children's Hospital of Pittsburgh Primary Care Center",{"type":87,"coordinates":99},[89,90],{"lat":90,"lon":89},[102,103],{"name":71,"role":75,"phone":76,"phoneExt":38,"email":77},{"name":71,"role":72,"phone":38,"phoneExt":38,"email":38},{"type":72,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"Kristin Ray","Associate Professor of Pediatrics",[108],{"name":109,"class":110},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH","100657959","enhanced-telemedicine-in-primary-care-for-acute-respiratory-tract-infections-study-100657959",false,"NCT07845526","Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study","Enhanced Telemedicine in Primary Care for ARTIs (Tele-PARTI) Study","Tele-PARTI","Inclusion Criteria:\n\n* Child receives primary care at a participating study site\n* Child is between 6 months 0 days and 23 months 29 days\n* Child has one or more documented acute otitis media infections (diagnosed on the day of enrollment or previously)\n* Child presents with an adult who is the biological parent or legally authorized representative able to provide consent for the child's participation in the study.\n\nExclusion Criteria:\n\n* Adult caregiver not able to participate in informed consent in English or Spanish\n* Child has congenital anomaly of face or ears\n* Child has history of myringotomy tube placement\n* Family lacks smart phone in household to pair with otoscope\n* Sibling or other child in same household already enrolled","ALL","6 Months","24 Months",{"count":123,"type":124},450,"ESTIMATED","INTERVENTIONAL",[127],"NA","Young children often receive antibiotics for pediatric acute respiratory tract infections (ARTIs) - common childhood diagnoses like ear infections, strep throat, sinusitis, and colds - but many of these antibiotics are prescribed unnecessarily for viral infections, where antibiotics will not help. Helping families and pediatricians to evaluate children with ARTIs through primary care telemedicine visits using at-home tele-otoscopes vs. at-home eBooks could help reduce unnecessary antibiotic exposure in children. In this clinical trial, we will assess the impact of at-home tele-otoscope vs. eBook enabled primary care telemedicine on antibiotic use, healthcare utilization, and healthcare costs for young children.",[130,131,132,133,134],"Acute Respiratory Tract Infection","Ear Infection","Throat Infection","Acute Respiratory Tract Infections","Common Cold",[136,137,138,139],"acute respiratory tract infection","ear infection","pediatric","telemedicine","NOT_YET_RECRUITING","2026-09-22",{"date":143,"type":144},"2026-09-29","ACTUAL",{"date":146,"type":124},"2026-11",{"date":148,"type":124},"2030-04",{"name":5,"class":6},2]