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.
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.
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 myringotomy tube placement
Family lacks smart phone in household to pair with otoscope
Parallel
Tele-Otoscope Enabled Primary Care
Other interventionChildren 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.
eBook-supported primary care
Other interventionChildren 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.
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.
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.
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.
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.
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.
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University of Pittsburgh
Lead sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
