Skip to main content
Clinical Trials/NCT02610699
NCT02610699
Completed
Not Applicable

CellScope Oto - Community Pediatric Acceptability Study (CPAS)

Emory University1 site in 1 country75 target enrollmentNovember 2014
ConditionsOtitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Otitis
Sponsor
Emory University
Enrollment
75
Locations
1
Primary Endpoint
Rate of antibiotic prescription following otic examination with smartphone otoscope device compared to conventional otoscope device
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

Ear infections, or otitis media, are a leading cause of health expenditures and antimicrobial prescriptions in children. Diagnosis of otitis media requires the ability to view the tympanic membrane. An instrument called an otoscope with a light source and a magnifying lens with a plastic tip that conforms to the ear canal is currently the standard of care for examining the tympanic membrane. Interpretation of otoscopic examinations is operator-dependent and cannot be seen by anyone other than the person holding the otoscope. A pocket size attachment that uses the technology and light source of a smartphone to capture images of the ear canal and tympanic membrane facilitates image documentation of the otic examination. In previous studies with the device, the investigators have shown that image quality of photographs of the tympanic membrane taken with the smartphone otoscope are equivalent to those taken with a camera-fitted conventional otoscope.

In this study, the Community Provider Assessment Study (CPAS), the investigators will perform a cross-sectional study in which they will randomly assign 3-4 pediatricians to use a smartphone otoscope as the standard of care device for all ear examinations and 3-4 pediatricians to use a conventional otoscope for alternating 1 month periods for 6 months. The parents of children examined during the study period with both devices will be invited to participate in 3 telephone surveys assessing parental satisfaction with the device and antimicrobial use by their child for the otic complaint. The results of this study have the potential to improve diagnosis and management of otitis media, thus improving patient care, reducing costs, and decreasing the opportunity for the development of antimicrobial resistance.

Registry
clinicaltrials.gov
Start Date
November 2014
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Andi L. Shane, MD

Associate Professor of Pediatrics

Emory University

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of an otic complaint
  • Willing to undergo otoscopy

Exclusion Criteria

  • Unwilling or unable to to complete study telephone questionnaires
  • Do not meet inclusion criteria

Outcomes

Primary Outcomes

Rate of antibiotic prescription following otic examination with smartphone otoscope device compared to conventional otoscope device

Time Frame: 4 weeks following enrollment

The rate of antibiotic prescription will be assessed by a parent questionnaire. Parents will be asked if they felt comfortable watching and waiting before filling their child's antibiotic prescription. The number of prescriptions filled will be noted.

Secondary Outcomes

  • Rate of completion of antibiotic course following otic examination with smartphone otoscope device compared to conventional otoscope device(4 weeks following enrollment)
  • Acceptability of management plan following examination with smartphone otoscope device compared to conventional otoscope device(4 weeks following enrollment)
  • Time of antibiotic filling following otic examination with smartphone otoscope device compared to conventional otoscope device smartphone otoscope device compared to conventional otoscope device(4 weeks following enrollment)

Study Sites (1)

Loading locations...

Similar Trials