Clinical trial NCT02918773: Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
Official title: Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Otitis Media
Acute Otitis Externa
Keywords: Pediatrics
Emergency Medicine
Ear infection
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Institute of Technology
name: Children's Healthcare of Atlanta
First posted: 2016-09-29
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of Antibiotic Prescriptions
timeFrame: Month 6
Secondary outcomes:
measure: Number of Diagnoses of Acute Otitis Media (AOM)
timeFrame: Month 6
measure: Number of Diagnoses of Otitis Externa
timeFrame: Month 6
measure: Clinician Acceptability of the Smartphone Otoscopic Device
timeFrame: Month 6
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Hughes Spalding
state: Georgia
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta at Egleston
state: Georgia
Study officials:
affiliation: Emory University
name: Andrea Shane, MD, MPH, MSc
role: PRINCIPAL_INVESTIGATOR
References: