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

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.

Study Overview

• Status: Recruiting
• Conditions: Otitis Media Acute
• Intervention / Treatment: Device: OtoSight Middle Ear Scope

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).

• Study Type: Observational
• Enrollment (Estimated): 700

Contacts and Locations

• Study Contact: Name: Madeleine M. Martine, MA; Phone Number: 1 6517283403; Email: mad.martine0223@gmail.com
• Study Contact Backup: Name: Ryan Nolan, M.Eng., CCRP; Phone Number: 1 664113277; Email: rnolan@photoni.care

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Not yet recruiting
      • Children's National Hospital
      • Contact: Bobbe Thomas
  • New York
    • Rochester, New York, United States, 14620
      • Recruiting
      • Trillim Health
      • Contact: Shealynn Hilliard
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Recruiting
      • Cyn3rgy Research
      • Contact: Allie Calaman
  • South Carolina
    • Orangeburg, South Carolina, United States, 29118
      • Recruiting
      • Carolina ENT
      • Contact: Simone Ansley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Standard of Care #1; Prospective Randomized Control Trial (RCT)
OtoSight #1; Prospective Randomized Control Trial (RCT)	Device: OtoSight Middle Ear Scope; Subjects will be evaluated with the OtoSight Middle Ear Scope
OtoSight #2; Case and provider match	Device: OtoSight Middle Ear Scope; Subjects will be evaluated with the OtoSight Middle Ear Scope
Standard of Care #2; Retrospective case and provider matched controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change the clinician rate of antibiotic prescriptions	Antibiotic stewardship	Baseline to 12 month Follow Up
Change the number of antibiotic rounds per patient	Antibiotic stewardship	Baseline to 12 month Follow Up
Change costs associated with management of pediatric patients presenting with ear-related pain	Change in overall costs	Baseline to 21 month Follow Up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in unnecessary antibiotic prescriptions	Change in unnecessary antibiotic prescriptions based on reported diagnosis and treatment recommendations of providers	Baseline to 12 month Follow Up
Change in prescription adherence	Change in prescription adherence	Baseline to 12 month Follow Up
Change in antibiotic prescription rate when fluid not present	Change in antibiotic prescriptions rate when fluid is not present based on reported treatment recommendations of providers	Baseline to 12 month Follow Up
Improve patient outcomes	Change in progression to recurrent AOM (rAOM) based on tracking provider diagnoses	Baseline to 12 month Follow Up
Change medical resource utilization	Change in follow-up visit frequency, ENT (Ear, Nose, and Throat) referral frequency	Baseline to 30 days Follow Up
Change unnecessary medical intervention	Change in amount of unnecessary medical intervention (e.g., tympanostomy tube surgeries) based on tracking provider treatment recommendations and diagnoses	Baseline to 12 month Follow Up
Impact clinician confidence	Change in clinician confidence scores reported on Provider CRF	Baseline to 12 month Follow Up
Impact caregiver satisfaction	Change in clinician satisfaction scores reported on Provider CRF	Baseline to 12 month Follow Up
Change in Health-related Quality of Life (HQoL)	Change in HQoL scores reported on the OMO-22 and OM-6	Baseline to 12 month Follow Up

Collaborators and Investigators

• Sponsor: PhotoniCare, Inc.
• Collaborators: TTi Health Research & Economics

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Estimated): February 29, 2024

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Otitis Media; Machine Learning; Ear Infection; Otitis Media with Effusion
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media
• Other Study ID Numbers: 000003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes