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Community Pediatric Acceptability Study (CPAS) (CPAS)

Primary Purpose

Otitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventional otoscope
Smartphone otoscope
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Otitis

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Emory Children's Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Smartphone otoscope/Conventional otoscope

Conventional otoscope/Smartphone otoscope

Arm Description

Participating clinicians will use a smartphone otoscope for one month followed by a conventional otoscope for one month, alternating monthly, for a total of 6 months to examine children between 6 months and 18 years of age who have clinical signs of acute otitis media (AOM).

Participating clinicians will use a conventional otoscope for one month followed by a smartphone otoscope for one month, alternating monthly, for a total of 6 months to examine children between 6 months and 18 years of age who have clinical signs of acute otitis media (AOM).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 18, 2015
Last Updated
January 22, 2016
Sponsor
Emory University
Collaborators
Georgia Institute of Technology, Children's Healthcare of Atlanta
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1. Study Identification

Unique Protocol Identification Number
NCT02610699
Brief Title
Community Pediatric Acceptability Study (CPAS)
Acronym
CPAS
Official Title
CellScope Oto - Community Pediatric Acceptability Study (CPAS)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Georgia Institute of Technology, Children's Healthcare of Atlanta

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone otoscope/Conventional otoscope
Arm Type
Active Comparator
Arm Description
Participating clinicians will use a smartphone otoscope for one month followed by a conventional otoscope for one month, alternating monthly, for a total of 6 months to examine children between 6 months and 18 years of age who have clinical signs of acute otitis media (AOM).
Arm Title
Conventional otoscope/Smartphone otoscope
Arm Type
Active Comparator
Arm Description
Participating clinicians will use a conventional otoscope for one month followed by a smartphone otoscope for one month, alternating monthly, for a total of 6 months to examine children between 6 months and 18 years of age who have clinical signs of acute otitis media (AOM).
Intervention Type
Other
Intervention Name(s)
Conventional otoscope
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Smartphone otoscope
Other Intervention Name(s)
CellScope-Oto
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of antibiotic prescription following otic examination with smartphone otoscope device compared to conventional otoscope device
Description
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.
Time Frame
4 weeks following enrollment
Secondary Outcome Measure Information:
Title
Time of antibiotic filling following otic examination with smartphone otoscope device compared to conventional otoscope device smartphone otoscope device compared to conventional otoscope device
Description
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.
Time Frame
4 weeks following enrollment
Title
Rate of completion of antibiotic course following otic examination with smartphone otoscope device compared to conventional otoscope device
Description
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.
Time Frame
4 weeks following enrollment
Title
Acceptability of management plan following examination with smartphone otoscope device compared to conventional otoscope device
Description
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.
Time Frame
4 weeks following enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Shane, MD, MPH, MSc
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Community Pediatric Acceptability Study (CPAS)

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