Clinical trial NCT02610699: Community Pediatric Acceptability Study (CPAS)
Official title: CellScope Oto - Community Pediatric Acceptability Study (CPAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Institute of Technology
name: Children's Healthcare of Atlanta
First posted: 2015-11-20
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Rate of antibiotic prescription following otic examination with smartphone otoscope device compared to conventional otoscope device
timeFrame: 4 weeks following enrollment
Secondary outcomes:
measure: Time of antibiotic filling following otic examination with smartphone otoscope device compared to conventional otoscope device smartphone otoscope device compared to conventional otoscope device
timeFrame: 4 weeks following enrollment
measure: Rate of completion of antibiotic course following otic examination with smartphone otoscope device compared to conventional otoscope device
timeFrame: 4 weeks following enrollment
measure: Acceptability of management plan following examination with smartphone otoscope device compared to conventional otoscope device
timeFrame: 4 weeks following enrollment
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Children's Center
state: Georgia
Study officials:
affiliation: Emory University
name: Andrea Shane, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
References: