An interventional study of Tele-Otoscope Enabled Primary Care and eBook-supported primary care in Acute Respiratory Tract Infection, Ear Infection and Throat Infection, sponsored by University of Pittsburgh. Not yet recruiting at 2 sites in United States. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by University of Pittsburgh · Not applicable, Interventional, and Health services research
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.
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:
Aim 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.
Aim 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.
Exclusion Criteria:
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.
Other: Tele-Otoscope Enabled Primary Care
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.
Other: eBook-supported 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.
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.
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.
Time frame: From enrollment through 12 months after enrollment
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.
Time frame: From enrollment through 12 months after enrollment
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.
Time frame: From enrollment through 12 months after enrollment
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.
Time frame: From enrollment through 12 months after enrollment
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.
Time frame: From enrollment through 12 months after enrollment
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.
Time frame: From enrollment through 12 months after enrollment
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.
Time frame: From enrollment through 12 months after enrollment
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.
Time frame: From enrollment through 12 months after enrollment
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.
Time frame: From enrollment through 12 months after enrollment
Plan to share: Yes — Individual participant data that underlie the results reported in this article, after deidentification (test, tables, figures, and appendices).
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University of Pittsburgh