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Clinical Trial Summary

A pragmatic, mixed-method trial is to show the ability of OtoSight to change management of the pediatric patient presenting with ear pain in a way that improves patient outcomes and reduces costs.


Clinical Trial Description

Mixed method, multi-center, pragmatic, cluster-randomized effectiveness-implementation investigation focused on pediatric subjects presenting with ear complaints at the office setting. For the prospective randomized component, eligible clinicians at a given site will be randomized to one of two groups: the OtoSight intervention group or the usual care control group. There will be three (3) periods of post-intervention assessment: 10 days (optional), 6 months, and 12 months. Eligible subjects will be automatically enrolled (or invited to enroll) in the clinical trial and will receive information. Because this is a non-interference design, frontline care clinicians randomized to either arm will be asked to: (1) assess the presence or absence of fluid in the middle ear; (2) record a diagnosis; and (3) treat the patient as they would according to the information available to them. A separate retrospective historical matched control arm will also be conducted to analyze potential Hawthorne effect at a subset of collaborating practices or healthcare systems. Randomization of clinicians (and not children) will decrease contamination in the usual practice group (i.e., so clinicians are not asked to flip between intervention and usual care practices). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06285812
Study type Observational
Source PhotoniCare, Inc.
Contact Madeleine M. Martine, MA
Phone 6517283403
Email mad.martine0223@gmail.com
Status Recruiting
Phase
Start date January 10, 2023
Completion date May 30, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT05353569 - Coherent Optical Detection of Middle Ear Disease N/A
Completed NCT04722770 - Clinical Development of Deep Learning for the OtoSight