Acute Otitis Media, Ear Infection, Pediatric Disease
Conditions
Keywords
cellscope, mobile device, pediatric trainees, acute otitis media, ear infection
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.
Interventions
DEVICECellscope
Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Block randomization, pediatric trainees are exposed in 2-week blocks: 1 week with Cellscope available, 1 week with the traditional otoscope
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All trainees and supervisors * All patients where otoscopy would traditionally be indicated, at the discretion of the clinical team
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic | 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
| Measure | Time frame | Description |
|---|---|---|
| Interrater Reliability as Assessed by a Kappa Statistic | 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. |
| Number of Patients Who Receive Antibiotics | 6 months | Number of patients who receive antibiotics between traditional otoscope and cellscope. |
| Number of Participants Who Receive a Repeat Examination | 6 months | Number of participants who receive a repeat examination between traditional otoscope and cellscope. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Traditional Otoscope 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. | 98 |
| Cellscope 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.
Cellscope: Cellphone otoscope (Cellscope) to evaluate pediatric patient ears. | 99 |
| Total | 197 |
Baseline characteristics
| Characteristic | Cellscope | Total | Traditional Otoscope |
|---|---|---|---|
| Age, Customized 21 years and younger | 99 Participants | 197 Participants | 98 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 99 Participants | 197 Participants | 98 Participants |
| Sex: Female, Male Female | — | 0 Participants | — |
| Sex: Female, Male Male | — | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 98 | 0 / 99 |
| other Total, other adverse events | 0 / 98 | 0 / 99 |
| serious Total, serious adverse events | 0 / 98 | 0 / 99 |
Outcome results
Primary
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
Population: 2 subjects were excluded from analysis due to incomplete surveys in the traditional otoscope arm, and 7 from the cell scope arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Traditional Otoscope | Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic | 0.64 concordance-statistic |
| Cellscope | Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic | 0.75 concordance-statistic |
Secondary
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
Population: 2 subjects were excluded from analysis due to incomplete surveys in the traditional otoscope arm, and 8 from the cell scope arm.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Traditional Otoscope | Interrater Reliability as Assessed by a Kappa Statistic | 0.37 Fleiss' Kappa |
| Cellscope | Interrater Reliability as Assessed by a Kappa Statistic | 0.67 Fleiss' Kappa |
Secondary
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
Population: 2 subjects were excluded from analysis due to incomplete surveys in the traditional otoscope arm, and 7 from the cell scope arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Otoscope | Number of Participants Who Receive a Repeat Examination | 94 Participants |
| Cellscope | Number of Participants Who Receive a Repeat Examination | 25 Participants |
Secondary
Number of Patients Who Receive Antibiotics
Number of patients who receive antibiotics between traditional otoscope and cellscope.
Time frame: 6 months
Population: 2 subjects were excluded from analysis due to incomplete surveys in the traditional otoscope arm, and 6 from the cell scope arm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Otoscope | Number of Patients Who Receive Antibiotics | 21 Participants |
| Cellscope | Number of Patients Who Receive Antibiotics | 11 Participants |