Clinical trial NCT04296448: Evaluation of Cellphone Based Otoscopy in Pediatric Patients
Official title: Evaluation of Cellphone Based Otoscopy in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ear Infection
Pediatric Disease
Acute Otitis Media
Keywords: cellscope
mobile device
pediatric trainees
acute otitis media
ear infection
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-03-05
Enrollment: 197
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomization, pediatric trainees are exposed in 2-week blocks: 1 week with Cellscope available, 1 week with the traditional otoscope
Primary purpose: DIAGNOSTIC

Brief summary: The Cellscope is an iPhone-based otoscope that uses the iPhone camera and light source to capture HIPAA compliant images and video recordings of the external and middle ear structure. This technology allows multiple providers, at different levels of training, the ability to simultaneously exam a child's external and middle ear structures. The investigators hypothesize this device will result in improved concordance in trainee/supervisor exam findings, increase trainee confidence in exam findings, decreased antibiotic prescriptions, and fewer repeat exams by multiple providers. Thus, this study has the potential to improve physician training and examination confidence, decrease the unnecessary use of antibiotics, and improve the patient/caregiver experience in healthcare interactions.

Detailed description: Abstract

Concerns about middle and external ear infections and discomfort are frequent chief complaints that bring children to pediatric providers. On top of this, there are numerous non-ear complaints (e.g. head trauma) that warrant a complete evaluation of the middle and external ear structures. At present, the middle and external ear is examined with standard direct otoscopy, commonly using a handheld otoscope. Otoscopy is defined as the visualization of the external and middle ear structures, including the tympanic membrane, ossicles, middle ear fluid, ear canal, etc. The skill of otoscopy is taught early in the medical trainees' career, most often in the first or second year of medical school. This skill is further honed during the pediatric medical student clerkship and pediatric residency, however there is not an efficient and patient-centered mechanism for direct visualization and teaching of trainees. Because of this, it is nearly impossible for trainees to receive feedback on trainees' visualization and interpretation skills. Based on the investigators' experience, trainee exams are often not repeated by clinical supervisors as the trainees progress in training. When supervisors do repeat ear exams (i.e., trainee is uncertain of findings), it is challenging to determine if the trainee fully appreciates exam findings. Ear exam findings directly inform the clinical decision-making (e.g., prescribing antibiotics for acute otitis media (AOM)) and uncertainty often results in unnecessary prescribing.

Objectives

Aim 1: To establish whether a smartphone otoscope improves diagnostic accuracy of tympanic membrane (TM) pathology for trainees, compared to supervisor.

Aim 2: To determine whether smartphone otoscope improves diagnostic confidence of trainees, thereby reducing frequency of antibiotic prescriptions for AOM.

Aim 3: To determine whether there is a change in repeat exam rates by supervisors, comparing with/without Cellscope.

Aim 4: To determine whether trainees convert to traditional otoscope use during the weeks that Cellscope is available.

Eligibility criteria: Inclusion Criteria:

* All trainees and supervisors
* All patients where otoscopy would traditionally be indicated, at the discretion of the clinical team

Exclusion Criteria:

* None

Primary outcomes:
measure: Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic
timeFrame: 6 months
Secondary outcomes:
measure: Interrater Reliability as Assessed by a Kappa Statistic
timeFrame: 6 months
measure: Number of Patients Who Receive Antibiotics
timeFrame: 6 months
measure: Number of Participants Who Receive a Repeat Examination
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Children's Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Therese Canares, MD
role: PRINCIPAL_INVESTIGATOR
References: