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

Otitis Media Acute Clinical Trial

— OTO-MATIC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06285812
• Other study ID #: 000003
• Status: Recruiting
• Start date: January 10, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: February 2024
• Source: PhotoniCare, Inc.
• Contact: Madeleine M. Martine, MA
• Phone: 6517283403
• Email: mad.martine0223[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media Acute

Intervention

Device:
• OtoSight Middle Ear Scope
Subjects will be evaluated with the OtoSight Middle Ear Scope

Locations

Country	Name	City	State
United States	Cyn3rgy Research	Gresham	Oregon
United States	Carolina ENT	Orangeburg	South Carolina
United States	Trillim Health	Rochester	New York
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
PhotoniCare, Inc.	TTi Health Research & Economics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change the clinician rate of antibiotic prescriptions	Antibiotic stewardship	Baseline to 12 month Follow Up
Primary	Change the number of antibiotic rounds per patient	Antibiotic stewardship	Baseline to 12 month Follow Up
Primary	Change costs associated with management of pediatric patients presenting with ear-related pain	Change in overall costs	Baseline to 21 month Follow Up
Secondary	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
Secondary	Change in prescription adherence	Change in prescription adherence	Baseline to 12 month Follow Up
Secondary	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
Secondary	Improve patient outcomes	Change in progression to recurrent AOM (rAOM) based on tracking provider diagnoses	Baseline to 12 month Follow Up
Secondary	Change medical resource utilization	Change in follow-up visit frequency, ENT (Ear, Nose, and Throat) referral frequency	Baseline to 30 days Follow Up
Secondary	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
Secondary	Impact clinician confidence	Change in clinician confidence scores reported on Provider CRF	Baseline to 12 month Follow Up
Secondary	Impact caregiver satisfaction	Change in clinician satisfaction scores reported on Provider CRF	Baseline to 12 month Follow Up
Secondary	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