An interventional study of Cellscope in Ear Infection, Pediatric Disease and Acute Otitis Media, sponsored by Johns Hopkins University. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Diagnostic
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.
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.
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This study's enrollment of 197 is above the median of 126 across 173 interventional studies indexed under Otitis.
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Exclusion Criteria:
Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.
Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams.
Device: Cellscope
Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.
Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic
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.
Time frame: 6 months
Interrater Reliability as Assessed by a Kappa Statistic
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.
Time frame: 6 months
Number of Patients Who Receive Antibiotics
Number of patients who receive antibiotics between traditional otoscope and cellscope.
Time frame: 6 months
Number of Participants Who Receive a Repeat Examination
Number of participants who receive a repeat examination between traditional otoscope and cellscope.
Time frame: 6 months
| Milestone | Traditional Otoscope | Cellscope |
|---|---|---|
| Started | 98 | 99 |
| Completed | 98 | 99 |
| Not completed | 0 | 0 |
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.
| concordance-statistic | Traditional Otoscope | Cellscope |
|---|---|---|
| Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic | 0.64 (0.57 to 0.70) | 0.75 (0.69 to 0.81) |
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.
| Fleiss' Kappa | Traditional Otoscope | Cellscope |
|---|---|---|
| Interrater Reliability as Assessed by a Kappa Statistic | 0.37 (0.24 to 0.51) | 0.67 (0.57 to 0.78) |
Number of patients who receive antibiotics between traditional otoscope and cellscope.
| Participants | Traditional Otoscope | Cellscope |
|---|---|---|
| Number of Patients Who Receive Antibiotics | 21 | 11 |
Number of participants who receive a repeat examination between traditional otoscope and cellscope.
| Participants | Traditional Otoscope | Cellscope |
|---|---|---|
| Number of Participants Who Receive a Repeat Examination | 94 | 25 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Traditional Otoscope | 0/98 (0%) | 0/98 (0%) | 0/98 (0%) |
| Cellscope | 0/99 (0%) | 0/99 (0%) | 0/99 (0%) |
| Age, Customized(Participants) | Traditional Otoscope | Cellscope | Total |
|---|---|---|---|
| 21 years and younger | 98 | 99 | 197 |
| Sex: Female, Male(Participants) | Traditional Otoscope | Cellscope | Total |
|---|---|---|---|
| Female | — | — | 0 |
| Male | — | — | 0 |
| Race and Ethnicity Not Collected(Participants) | Traditional Otoscope | Cellscope | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Traditional Otoscope | Cellscope | Total |
|---|---|---|---|
| United States | 98 | 99 | 197 |
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