Community Pediatric Acceptability Study (CPAS)

Otitis Clinical Trial

— CPAS  

Official title:

CellScope Oto - Community Pediatric Acceptability Study (CPAS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610699
• Other study ID #: IRB00074526
• Status: Completed
• Phase: N/A
• First received: November 18, 2015
• Last updated: January 22, 2016
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: January 2016
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Otitis

Intervention

Other:
• Conventional otoscope
The conventional analogue otoscope will be used to provide a two-dimensional view of the ear canal. Clinicians will use this for one month periods for a total of 3 months.
• Smartphone otoscope
The smartphone otoscope is a pocket size smartphone attachment that uses technology and light source of a smartphone to capture reproducible images of the middle ear and tympanic membrane. Images and videos can be transmitted via real-time communication software from the device to another smartphone. Clinicians will use this for one month periods for a total of 3 months.

Locations

Country	Name	City	State
United States	Emory Children's Center	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Children's Healthcare of Atlanta, Georgia Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of antibiotic prescription following otic examination with smartphone otoscope device compared to conventional otoscope device	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.	4 weeks following enrollment	No
Secondary	Time of antibiotic filling following otic examination with smartphone otoscope device compared to conventional otoscope device smartphone otoscope device compared to conventional otoscope device	The time of filling of the antibiotic prescription will be assessed by a parent questionnaire. Parents will be asked how long they waited before they filled their child's prescription and the response recorded.	4 weeks following enrollment	No
Secondary	Rate of completion of antibiotic course following otic examination with smartphone otoscope device compared to conventional otoscope device	The rate of completion of the course of antibiotics will be assessed by a parent questionnaire. Parents will be asked if their child completed the course of prescribed antibiotics. The number of children who completed the entire course of antibiotics will be recorded.	4 weeks following enrollment	No
Secondary	Acceptability of management plan following examination with smartphone otoscope device compared to conventional otoscope device	The acceptability of the management plan following examination with the smartphone otoscope as compared to conventional otoscope will be assessed by a parent questionnaire. A 'yes' response to questions relating to smartphone device images will indicate acceptability.	4 weeks following enrollment	No