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NCT07328555 · ClinicalTrials.gov registry record · NA
Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children
A NA study, sponsored by Boston Children's Hospital.
- Active
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT07328555 is a NA study that is active but no longer recruiting, run by Boston Children's Hospital. The registered enrollment target is 36 participants.
The verdict
NCT07328555, a NA study, is active but no longer recruiting, sponsored by Boston Children's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study Summary
Randomized controlled trial involving 4 pediatric primary care practices in Massachusetts. Practices will be stratified by their OM diagnosis and treatment rate, with two practices randomly assigned to the intervention arm and two to the control arm. For practices randomized to the intervention arm, their offices will be equipped with digital otoscopes (Wispr Digital Otoscope, WiscMed) in each exam room in place of traditional otoscopes. Clinicians in intervention practices will attend a two-hour initial training session on the use of digital otoscopy followed by two one-hour follow-up sessions held over a two-month run-in period prior to the study start to review best practices and troubleshoot any difficulties adapting to the new technology. Upon completion of the run-in training period, a six-month data collection period will begin. The primary outcome will consist of a difference-in-difference analysis comparing the difference in the OM Treatment Index (OMTI) from the baseline period (October 1 through March 31, 2025) to the intervention period (October 1 through March 31, 2026) between the intervention practices and the control practices. The OMTI is a measure of the rate of diagnosis and antibiotic treatment of OM, specifically calculated as the number of cases with an OM diagnosis and systemic antibiotic prescribed divided by the number of visits with a diagnosis of any acute respiratory tract illness. Secondary outcomes include analogous difference-in-difference comparisons of: 1) overall antibiotic courses prescribed; 2) overall days of antibiotics prescribed; and 3) a balancing measure of the rate of return visits with any acute respiratory tract illness diagnosis within 7 days of an index visit. Additionally, clinicians will be surveyed to assess confidence and satisfaction in diagnosing OM and preference for digital versus traditional otoscopy. To incentivize participation, practices randomized to the control arm will be loaned digital otoscopes to u
Interventions
- DEVICE Device: Digital Otoscope
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2026-03-01 |
| Est. Completion | 2027-09-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07328555
The ClinicalTrials.gov registry entry for NCT07328555 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boston Children's Hospital, which has 462 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Device: Digital Otoscope is the first listed.
NCT07328555 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07328555 about?
NCT07328555 is a clinical study titled "Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children". Randomized controlled trial involving 4 pediatric primary care practices in Massachusetts. Practices will be stratified by their OM diagnosis and treatment rate, with two practices randomly assigned to the intervention arm and two to the control arm. For practices randomized to the intervention arm...
What is the current status of trial NCT07328555?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 36 participants. The study started on 2026-03-01. Estimated completion is 2027-09-30.
What interventions are being tested in trial NCT07328555?
The interventions under investigation include: Device: Digital Otoscope (DEVICE).
Who is sponsoring clinical trial NCT07328555?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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