Acute Otitis Externa, Acute Otitis Media
Conditions
Keywords
Pediatrics, Emergency Medicine, Ear infection
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.
Interventions
DEVICESmartphone otoscope
A smartphone otoscope is a pocket size smartphone attachment that uses the technology and light source of a smartphone to capture reproducible images of the ear canal and tympanic membrane. The smartphone otoscope has the capability to capture still images and video, which can be referred to post-examination as well as be incorporated into an electronic medical record. Clinicians will use the smartphone otoscope for the duration of the 6-month study period.
DEVICEConventional otoscope
A conventional otoscope has a light and lenses to provide a view of the ear canal and tympanic membrane or eardrum. Clinicians will use the conventional otoscope for the duration of the 6-month study period.
Sponsors
Georgia Institute of Technology
Children's Healthcare of Atlanta
Emory University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Antibiotic Prescriptions | Month 6 | The number of emergency department encounters where antibiotics were prescribed to treat acute otitis media (AOM) are presented here. Information about antimicrobial prescriptions were found in the medical records of children receiving an otoscopic exam by a participating clinician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Diagnoses of Acute Otitis Media (AOM) | Month 6 | The number of emergency department encounters where a diagnosis of acute otitis media (AOM) was made is presented here. Information about the diagnosis of AOM was found in the medical records of children receiving an otoscopic exam by a participating clinician. |
| Number of Diagnoses of Otitis Externa | Month 6 | The number of emergency department encounters where a diagnosis of otitis externa was made is presented here. Information about the diagnosis of otitis externa was found in the medical records of children receiving an otoscopic exam by a participating clinician. |
| Clinician Acceptability of the Smartphone Otoscopic Device | Month 6 | Clinicians randomized to use the smartphone otoscopic device completed a survey to assess the acceptability of this device compared to the historical use of a conventional otoscope. The survey, developed specifically for this study, asked clinicians to report on their preference for using the smartphone otoscope over the conventional otoscope, whether the device increased their ability to diagnose AOM, and the perceived impact on antibiotic prescribing. |
Countries
United States
Participant flow
Recruitment details
Twenty-two volunteer clinicians were randomly assigned to use either a smartphone otoscope device or a conventional otoscope for a six-month period from October 15, 2016 to April 15, 2017. This study was conducted at two children's hospital emergency departments in Atlanta, Georgia.
Pre-assignment details
Study clinicians logged 1,502 encounters where otoscopes were used; 112 (7%) of encounters were excluded due to incomplete data or not meeting study inclusion criteria, for a total of 1390 encounters evaluated.
Participants by arm
| Arm | Count |
|---|---|
| Conventional Otoscope Encounters Emergency department (ED) encounters by participating clinicians randomized to the conventional otoscope study arm. Clinicians randomized to this group used a conventional otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose. | 11 |
| Conventional Otoscope Encounters Emergency department (ED) encounters by participating clinicians randomized to the conventional otoscope study arm. Clinicians randomized to this group used a conventional otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose. | 776 |
| Smartphone Otoscope Encounters Emergency department (ED) encounters by participating clinicians randomized to the smartphone otoscope study arm. Clinicians randomized to this group used a smartphone otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose. | 11 |
| Smartphone Otoscope Encounters Emergency department (ED) encounters by participating clinicians randomized to the smartphone otoscope study arm. Clinicians randomized to this group used a smartphone otoscope for a 6-month period for all otic (ear) examinations for any non-traumatic complaints with the potential for otic involvement including fever, ear pain, congestion, or runny nose. | 614 |
| Total | 1,412 |
Baseline characteristics
| Characteristic | Smartphone Otoscope Encounters | Conventional Otoscope Encounters | Total |
|---|---|---|---|
| Age, Continuous | 49.0 age in months of encounter subjects STANDARD_DEVIATION 42 | 43.5 age in months of encounter subjects STANDARD_DEVIATION 38.8 | 45.90 age in months of encounter subjects STANDARD_DEVIATION 40.34 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Reason for clinic visit Congestion/runny nose | 182 Emergency department encounters | 270 Emergency department encounters | 452 Emergency department encounters |
| Reason for clinic visit Cough | 274 Emergency department encounters | 365 Emergency department encounters | 639 Emergency department encounters |
| Reason for clinic visit Ear pain | 96 Emergency department encounters | 106 Emergency department encounters | 202 Emergency department encounters |
| Reason for clinic visit Fever | 424 Emergency department encounters | 522 Emergency department encounters | 946 Emergency department encounters |
| Reason for clinic visit Other | 317 Emergency department encounters | 338 Emergency department encounters | 655 Emergency department encounters |
| Region of Enrollment United States | 614 Emergency department encounters | 776 Emergency department encounters | 1390 Emergency department encounters |
| Sex/Gender, Customized Not collected | 614 Emergency department encounters | 776 Emergency department encounters | 1390 Emergency department encounters |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 776 | 0 / 614 |
| other Total, other adverse events | 0 / 776 | 0 / 614 |
| serious Total, serious adverse events | 0 / 776 | 0 / 614 |
Outcome results
Primary
Number of Antibiotic Prescriptions
The number of emergency department encounters where antibiotics were prescribed to treat acute otitis media (AOM) are presented here. Information about antimicrobial prescriptions were found in the medical records of children receiving an otoscopic exam by a participating clinician.
Time frame: Month 6
Population: This analysis includes emergency department encounters with children by a participating clinician where AOM was diagnosed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Conventional Otoscope Encounters | Number of Antibiotic Prescriptions | Antibiotic prescribed | 140 Emergency department encounters |
| Conventional Otoscope Encounters | Number of Antibiotic Prescriptions | Antibiotic not prescribed | 6 Emergency department encounters |
| Conventional Otoscope Encounters | Number of Antibiotic Prescriptions | Unknown | 0 Emergency department encounters |
| Smartphone Otoscope Encounters | Number of Antibiotic Prescriptions | Antibiotic not prescribed | 7 Emergency department encounters |
| Smartphone Otoscope Encounters | Number of Antibiotic Prescriptions | Antibiotic prescribed | 115 Emergency department encounters |
| Smartphone Otoscope Encounters | Number of Antibiotic Prescriptions | Unknown | 1 Emergency department encounters |
Secondary
Clinician Acceptability of the Smartphone Otoscopic Device
Clinicians randomized to use the smartphone otoscopic device completed a survey to assess the acceptability of this device compared to the historical use of a conventional otoscope. The survey, developed specifically for this study, asked clinicians to report on their preference for using the smartphone otoscope over the conventional otoscope, whether the device increased their ability to diagnose AOM, and the perceived impact on antibiotic prescribing.
Time frame: Month 6
Population: Only participating clinicians who were randomized to use the smartphone otoscope were administered a survey at the end of the 6-month intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Conventional Otoscope Encounters | Clinician Acceptability of the Smartphone Otoscopic Device | Preferred smartphone over conventional otoscope | 8 Participants |
| Conventional Otoscope Encounters | Clinician Acceptability of the Smartphone Otoscopic Device | Smartphone increased ability to diagnose AOM | 3 Participants |
| Conventional Otoscope Encounters | Clinician Acceptability of the Smartphone Otoscopic Device | Smartphone did not impact antibiotic prescribing | 6 Participants |
Secondary
Number of Diagnoses of Acute Otitis Media (AOM)
The number of emergency department encounters where a diagnosis of acute otitis media (AOM) was made is presented here. Information about the diagnosis of AOM was found in the medical records of children receiving an otoscopic exam by a participating clinician.
Time frame: Month 6
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Conventional Otoscope Encounters | Number of Diagnoses of Acute Otitis Media (AOM) | AOM Diagnosed | 146 Emergency department encounters |
| Conventional Otoscope Encounters | Number of Diagnoses of Acute Otitis Media (AOM) | AOM Not Diagnosed | 630 Emergency department encounters |
| Smartphone Otoscope Encounters | Number of Diagnoses of Acute Otitis Media (AOM) | AOM Diagnosed | 123 Emergency department encounters |
| Smartphone Otoscope Encounters | Number of Diagnoses of Acute Otitis Media (AOM) | AOM Not Diagnosed | 491 Emergency department encounters |
Secondary
Number of Diagnoses of Otitis Externa
The number of emergency department encounters where a diagnosis of otitis externa was made is presented here. Information about the diagnosis of otitis externa was found in the medical records of children receiving an otoscopic exam by a participating clinician.
Time frame: Month 6
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Conventional Otoscope Encounters | Number of Diagnoses of Otitis Externa | Otitis Externa Diagnosed | 0 Emergency department encounters |
| Conventional Otoscope Encounters | Number of Diagnoses of Otitis Externa | Otitis Externa Not Diagnosed | 776 Emergency department encounters |
| Smartphone Otoscope Encounters | Number of Diagnoses of Otitis Externa | Otitis Externa Diagnosed | 0 Emergency department encounters |
| Smartphone Otoscope Encounters | Number of Diagnoses of Otitis Externa | Otitis Externa Not Diagnosed | 614 Emergency department encounters |