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Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)

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ClinicalTrials.gov Identifier: NCT02918773
Recruitment Status : Completed
First Posted : September 29, 2016
Results First Posted : July 13, 2018
Last Update Posted : July 13, 2018
Sponsor:
Collaborators:
Georgia Institute of Technology
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Andi L. Shane, MD, Emory University

Brief Summary:
Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading cause of health encounters and antimicrobial prescriptions in children worldwide. Diagnosis of AOM is often dependent on a brief view of the tympanic membrane in an uncooperative child's ear canal. As a consequence, AOM may be inappropriately diagnosed when visualization of the tympanic membrane (ear drum) is not optimal. Improved methods for visualizing the tympanic membrane including capturing still images and recording video of the ear exam would be beneficial in the diagnosis and management of otic complaints, including acute and chronic otitis media. Use of a smartphone otoscope has the potential to optimize clinician ability to manage otic complaints, visualize the tympanic membrane, and support antimicrobial stewardship. This study will be conducted as a randomized control study in two affiliated children's hospital emergency departments. Twenty volunteer clinicians will be randomly assigned to use either a smartphone otoscope or a conventional otoscope for all otic examinations for a 6-month period.

Condition or disease Intervention/treatment Phase
Acute Otitis Media Acute Otitis Externa Device: Smartphone otoscope Device: Conventional otoscope Not Applicable

Detailed Description:
A smartphone otoscope (CellScope-Oto) is a pocket size attachment that employs the technology and light source of a smartphone to capture reproducible images of the ear canal and tympanic membrane. Previous studies with this device demonstrated that images taken with both the smartphone otoscope and a camera-fitted conventional analogue otoscope were equivalent with respect to image quality and that the smartphone otoscope was acceptable as an educational and diagnostic tool to health professional students. A pilot study with a similar design to this study conducted in two offices of an ambulatory pediatric clinic demonstrated a trend toward decreased antimicrobial prescription filling among families whose children were examined with the smartphone otoscope compared to those who were examined with a conventional otoscope. To further assess this trend, this study proposes an evaluation of the impact of device use on antimicrobial prescribing for children with an otic complaint in a pediatric emergency department (PED) setting. This study will enroll 20 clinicians for the 6-month study period; 10 who will be randomly assigned to use a smartphone otoscope for the 6-month study period and 10 who will be assigned to use a conventional otoscope for all otoscopic exams. Data will be abstracted via retrospective review of the electronic medical record of encounters in with an otoscopic exam was performed as part of the diagnostic evaluation.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
Actual Study Start Date : October 15, 2016
Actual Primary Completion Date : April 15, 2017
Actual Study Completion Date : April 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arm Intervention/treatment
Experimental: Smartphone otoscope
Participating clinicians randomized to the smartphone otoscope study arm will use a smartphone otoscope for all otic (ear) examinations for a 6-month period.
Device: Smartphone otoscope
A smartphone otoscope is a pocket size smartphone attachment that uses the technology and light source of a smartphone to capture reproducible images of the ear canal and tympanic membrane. The smartphone otoscope has the capability to capture still images and video, which can be referred to post-examination as well as be incorporated into an electronic medical record. Clinicians will use the smartphone otoscope for the duration of the 6-month study period.
Other Name: CellScope-Oto

Active Comparator: Conventional otoscope
Participating clinicians randomized to the conventional otoscope study arm will use a conventional otoscope for all otic (ear) examinations for a 6-month period.
Device: Conventional otoscope
A conventional otoscope has a light and lenses to provide a view of the ear canal and tympanic membrane or eardrum. Clinicians will use the conventional otoscope for the duration of the 6-month study period.




Primary Outcome Measures :
  1. Number of Antibiotic Prescriptions [ Time Frame: Month 6 ]
    The number of emergency department encounters where antibiotics were prescribed to treat acute otitis media (AOM) are presented here. Information about antimicrobial prescriptions were found in the medical records of children receiving an otoscopic exam by a participating clinician.


Secondary Outcome Measures :
  1. Number of Diagnoses of Acute Otitis Media (AOM) [ Time Frame: Month 6 ]
    The number of emergency department encounters where a diagnosis of acute otitis media (AOM) was made is presented here. Information about the diagnosis of AOM was found in the medical records of children receiving an otoscopic exam by a participating clinician.

  2. Number of Diagnoses of Otitis Externa [ Time Frame: Month 6 ]
    The number of emergency department encounters where a diagnosis of otitis externa was made is presented here. Information about the diagnosis of otitis externa was found in the medical records of children receiving an otoscopic exam by a participating clinician.

  3. Clinician Acceptability of the Smartphone Otoscopic Device [ Time Frame: Month 6 ]
    Clinicians randomized to use the smartphone otoscopic device completed a survey to assess the acceptability of this device compared to the historical use of a conventional otoscope. The survey, developed specifically for this study, asked clinicians to report on their preference for using the smartphone otoscope over the conventional otoscope, whether the device increased their ability to diagnose AOM, and the perceived impact on antibiotic prescribing.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participants must be a pediatric emergency care clinicians providing care at an emergency department a participating children's hospital
  • Willing to agree to random assignment to either a smartphone otoscope device or a conventional otoscope device for the 6-month study period
  • Willing to log patient encounters that included the an otoscopic examination for non-traumatic indication for each shift
  • Willing to document and report episodes of care in which the assigned otoscopic device could not be used on a study-eligible otoscopic examination
  • Willing to complete an end of study assessment, if assigned to use the smartphone otoscope

Exclusion Criteria:

  • Declines to give informed consent to participate in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918773


Locations
United States, Georgia
Children's Healthcare of Atlanta at Hughes Spalding
Atlanta, Georgia, United States, 30303
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Georgia Institute of Technology
Children's Healthcare of Atlanta
Investigators
Principal Investigator: Andrea Shane, MD, MPH, MSc Emory University
  Study Documents (Full-Text)

Documents provided by Andi L. Shane, MD, Emory University:

Responsible Party: Andi L. Shane, MD, Associate Professor, Emory University
ClinicalTrials.gov Identifier: NCT02918773     History of Changes
Other Study ID Numbers: IRB00090777
First Posted: September 29, 2016    Key Record Dates
Results First Posted: July 13, 2018
Last Update Posted: July 13, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Andi L. Shane, MD, Emory University:
Pediatrics
Emergency Medicine
Ear infection

Additional relevant MeSH terms:
Emergencies
Otitis
Otitis Media
Otitis Externa
Disease Attributes
Pathologic Processes
Ear Diseases
Otorhinolaryngologic Diseases