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Completed

NCT Number: NCT04296448

Evaluation of Cellphone Based Otoscopy in Pediatric Patients

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.

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Key information

Conditions

Ear Infection Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases Pediatric Disease

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Children's Center

Baltimore, Maryland, 21212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Cellscope

Device

Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.

Primary outcomes

  1. Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic

    Time frame: 6 months

    Concordance of trainee and supervisor utilizing the OMgrade scale, between traditional otoscope and cellscope. Concordance is determined by the concordance-statistic (0-1) in a logistic regression model. The closer the number is to 1 the higher the concordance.

Secondary outcomes

  1. Interrater Reliability as Assessed by a Kappa Statistic

    Time frame: 6 months

    Kappa statistic (Fleiss' Kappa) of trainee and supervisor utilizing the OMgrade scale. The kappa statistic ranges from 0-1. The closer the number is to 1 the higher the agreement.

  2. Number of Patients Who Receive Antibiotics

    Time frame: 6 months

    Number of patients who receive antibiotics between traditional otoscope and cellscope.

  3. Number of Participants Who Receive a Repeat Examination

    Time frame: 6 months

    Number of participants who receive a repeat examination between traditional otoscope and cellscope.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2020
Registry last updated
Aug 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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