Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children

OTO-MATIC: Otitis Treatment With OtoSight™ - Modification of Antibiotic Treatment Intervention in Children

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.

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).

For the Prospective Subjects

Inclusion Criteria:

• Pediatric subjects between 6 months and 17 years of age
• Pediatric subjects presenting for an office visit with ear-related pain (otalgia)/otic complaints/earache indicative of potential Otitis Media with Effusion (OME) or Acute Otitis Media (AOM)
• Pediatric subjects where otoscopy would traditionally be indicated
• Pediatric subjects whose parents or legally authorized representative (LAR) have signed an informed consent

Exclusion Criteria:

• The parent or guardian who attends visits does not speak the same language as their physician
• Pediatric subjects enrolled in another clinical trial
• Pediatric subjects with:
• Signs of severe chronic illness (e.g., immunodeficiency, congenital heart disease, encephalopathy, pulmonary disease other than asthma, and disorder of the ear, nose and throat) or any clinically significant illness or condition that, in the opinion of the investigator, would prohibit the subject from participating in the trial
• Anatomical conditions that would affect their ability to undergo an otoscopy.

For the Retrospective Case Match Controls

Inclusion Criteria:

• Pediatric subjects between 6 months and 17 years of age (< 18 years old).
• Index visit took place 11 - 25 months prior to the Treatment match's Baseline Visit.
• Index visit was for an ear-related chief complaint.
• An otoscopic exam was completed at index visit.
• Subjects have a follow up visits (telehealth included) in the time period between the index visit and firstTreatment subject's enrollment date.