Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Tele-PARTI
2 other identifiers
interventional
450
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2026
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2026
CompletedFirst Posted
Study publicly available on registry
September 29, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2030
Study Completion
Last participant's last visit for all outcomes
April 1, 2030
September 29, 2026
September 1, 2026
3.4 years
September 22, 2026
September 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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.
From enrollment through 12 months after enrollment
Secondary Outcomes (7)
Number of ARTI antibiotic days prescribed
From enrollment through 12 months after enrollment
Number of ARTI broad-spectrum antibiotic courses
From enrollment through 12 months after enrollment
Number of total antibiotic courses (any diagnosis)
From enrollment through 12 months after enrollment
Number of ARTI visits overall and by site (ED, urgent care, primary care)
From enrollment through 12 months after enrollment
Percentage of ARTI visits resulting in antibiotic prescription
From enrollment through 12 months after enrollment
- +2 more secondary outcomes
Study Arms (2)
Tele-Otoscope
EXPERIMENTALChildren 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.
eBook
PLACEBO COMPARATORChildren 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
- Sibling or other child in same household already enrolled
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UPMC Children's Community Pediatrics
Pittsburgh, Pennsylvania, 15213, United States
UPMC Children's Hospital of Pittsburgh Primary Care Center
Pittsburgh, Pennsylvania, 15213, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristin Ray, MD, MS
University of Pittsburgh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
September 22, 2026
First Posted
September 29, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
April 1, 2030
Study Completion (Estimated)
April 1, 2030
Last Updated
September 29, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- 12 months after final publication until 36 months after publication
- Access Criteria
- Researchers will be able to access de-identified IPD by contacting the principal investigator and securing data use agreements.
Individual participant data that underlie the results reported in this article, after deidentification (test, tables, figures, and appendices).