Clinical trial NCT06285812: Otitis Treatment with OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
Official title: OTO-MATIC: Otitis Treatment with OtoSight™ - Modification of Antibiotic Treatment Intervention in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Otitis Media Acute
Keywords: Otitis Media with Effusion
Ear Infection
Optical Coherence Tomography
Otitis Media
Machine Learning
Lead sponsor: PhotoniCare, Inc.
Sponsor class: INDUSTRY
Collaborators: name: TTi Health Research & Economics
First posted: 2024-02-29
Enrollment: 700
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any pediatric patient between 6 months and 17 years of age scheduled for an office visit with ear-related complaints, deemed suitable for otoscopy assessment.

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change the clinician rate of antibiotic prescriptions
timeFrame: Baseline to 12 month Follow Up
measure: Change the number of antibiotic rounds per patient
timeFrame: Baseline to 12 month Follow Up
measure: Change costs associated with management of pediatric patients presenting with ear-related pain
timeFrame: Baseline to 21 month Follow Up
Secondary outcomes:
measure: Change in unnecessary antibiotic prescriptions
timeFrame: Baseline to 12 month Follow Up
measure: Change in prescription adherence
timeFrame: Baseline to 12 month Follow Up
measure: Change in antibiotic prescription rate when fluid not present
timeFrame: Baseline to 12 month Follow Up
measure: Improve patient outcomes
timeFrame: Baseline to 12 month Follow Up
measure: Change medical resource utilization
timeFrame: Baseline to 30 days Follow Up
measure: Change unnecessary medical intervention
timeFrame: Baseline to 12 month Follow Up
measure: Impact clinician confidence
timeFrame: Baseline to 12 month Follow Up
measure: Impact caregiver satisfaction
timeFrame: Baseline to 12 month Follow Up
measure: Change in Health-related Quality of Life (HQoL)
timeFrame: Baseline to 12 month Follow Up
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
city: Miami
country: United States
facility: Abba Medical Group LLC
state: Florida
city: Orlando
country: United States
facility: AdventHealth Children's Research
state: Florida
city: Rochester
country: United States
facility: Trillim Health
state: New York
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Orangeburg
country: United States
facility: Carolina ENT
state: South Carolina
city: Morristown
country: United States
facility: HealthStar Physicians
state: Tennessee
Study officials:
References: