University of Pittsburgh
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 ec…
Inclusion Criteria: * Child receives primary care at a participating study site * Child is between 6 months 0 days and 23 months 29 days * Child has one or more documented acute otitis media infections (diagnosed on the day of enrollment or previously) * 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. Exclusion Criteria: * Adult caregiver not able to participate in informed consent in English or Spanish * Child has congenital anomaly of face or ears * Child has history of myrin…
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.
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