Acute Respiratory Tract InfectionTele-PARTINCT07845526
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
A study testing Tele-Otoscope Enabled Primary Care and eBook-supported primary care in people with Acute Respiratory Tract Infection and Ear Infection, run by University of Pittsburgh at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 24 months
- Conditions the study is for
- Acute Respiratory Tract Infection, Ear Infection, Throat Infection
- What is being tested?
- Tele-Otoscope Enabled Primary Care and eBook-supported primary care
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2026to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
UPMC Children's Community Pediatrics
Pittsburgh, Pennsylvania, 15213
CCP Research Medical Director, 412-465-0173, patrick.tate2@chp.edu
UPMC Children's Hospital of Pittsburgh Primary Care Center
Pittsburgh, Pennsylvania, 15213
Kristin Ray, MD, MS, 412-465-0173, knr16@pitt.edu
Kristin Ray, MD, MS
About this study
Official title: Enhanced Telemedicine in Primary Care for ARTIs (Tele-PARTI) Study
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, the investigators 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.
Read the detailed description
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.
- Conditions
- Acute Respiratory Tract Infection, Ear Infection, Throat Infection, Acute Respiratory Tract Infections, Common Cold
- Being tested
- Tele-Otoscope Enabled Primary Care, eBook-supported primary care
- Keywords
- acute respiratory tract infection, ear infection, pediatric, telemedicine
- Medical subject headings
- Otitis, Pharyngitis, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Otoscope Enabled Primary CareOther
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.
eBook-supported primary careOther
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, the investigators 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Tele-Otoscope Enabled Primary Care |
| 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, the investigators 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. Receives: Other: eBook-supported primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From enrollment through 12 months after enrollment
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment through 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristin Ray, University of Pittsburgh
- Investigators
- Kristin Ray, MD, MS, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845526
- Sponsor's protocol ID
- STUDY26060067
- Other IDs
- R01AI201390
- Acronym
- Tele-PARTI
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (test, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Telemedicine in Primary Care for ARTIs (Tele-PARTI) Study
- ClinicalTrials.gov ID
- NCT07845526
- Acronym / sponsor ID
- Tele-PARTI / STUDY26060067
- Conditions
- Acute Respiratory Tract Infection, Ear Infection, Throat Infection, Acute Respiratory Tract Infections, Common Cold
- Keywords
- acute respiratory tract infection, ear infection, pediatric, telemedicine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, the investigators 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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-Otoscope | Experimental | Other: Tele-Otoscope Enabled Primary CareChildren 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 comparator | Other: eBook-supported primary careChildren 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, the investigators 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. |
Who may qualify
- Ages
- 6 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-Otoscope Enabled Primary CareChildren 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. | Other | Tele-Otoscope |
| eBook-supported primary careChildren 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, the investigators 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 |
Primary outcome
Number of ARTI antibiotics
Time frame: From enrollment through 12 months after enrollment
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
Time frame: From enrollment through 12 months after enrollment
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.
7 secondary outcomes
Number of ARTI antibiotic days prescribed
Time frame: From enrollment through 12 months after enrollment
Number of ARTI broad-spectrum antibiotic courses
Time frame: From enrollment through 12 months after enrollment
Number of total antibiotic courses (any diagnosis)
Time frame: From enrollment through 12 months after enrollment
Number of ARTI visits overall and by site (ED, urgent care, primary care)
Time frame: From enrollment through 12 months after enrollment
Percentage of ARTI visits resulting in antibiotic prescription
Time frame: From enrollment through 12 months after enrollment
Total annual family out of pocket costs
Time frame: From enrollment through 12 months after enrollment
Total annual costs from the primary care practice perspective
Time frame: From enrollment through 12 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (test, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristin Ray, MD, MS principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Otoscope Enabled Primary Care and eBook-supported primary care in people with Acute Respiratory Tract Infection and Ear Infection, run by University of Pittsburgh at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristin Ray, MD, MS (412-465-0173, knr16@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ARTI antibiotics (time frame: From enrollment through 12 months after enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.