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| Name | Class |
|---|---|
| Georgia Institute of Technology | OTHER |
| Children's Healthcare of Atlanta | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Smartphone otoscope | Experimental | Participating clinicians randomized to the smartphone otoscope study arm will use a smartphone otoscope for all otic (ear) examinations for a 6-month period. |
|
| Conventional otoscope | Active Comparator | Participating clinicians randomized to the conventional otoscope study arm will use a conventional otoscope for all otic (ear) examinations for a 6-month period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone otoscope | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Shane, MD, MPH, MSc | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Healthcare of Atlanta at Hughes Spalding | Atlanta | Georgia | 30303 | United States | ||
| Children's Healthcare of Atlanta at Egleston |
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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.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | Conventional Otoscope Encounters | Emergency department 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. |
| FG001 | Smartphone Otoscope Encounters | Emergency department 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The attributes of the children seen in the pediatric emergency department who were examined by clinicians participating in the study are presented in the baseline analysis. Only minimal information was collected from the medical records regarding the baseline characteristics of these children..
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The age of one child in the smartphone otoscope group is unknown. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | This analysis includes emergency department encounters with children by a participating clinician where AOM was diagnosed. | Posted | Number | Emergency department encounters | Month 6 | Number of encounters | Number of encounters |
|
Adverse events were collected during the 6-month intervention period of October 15, 2016 to April 15, 2017.
This study collected any adverse events related to otoscope use, however, adverse events were not expected as the intervention does not pose more than minimal risk to patients being examined. Adverse events are reported on the emergency department encounter level rather than the clinician participant level.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional Otoscope Encounters | Emergency department 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andi L Shane MD/MPH/MSc | Emory University | 404-727-9880 | ashane@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 16, 2016 | Jun 11, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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|
|
| Conventional otoscope | Device | 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. |
|
| 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. |
| Month 6 |
| 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. | Month 6 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| ED encounters |
|
| Mean |
| Standard Deviation |
| age in months of encounter subjects |
| ED encounters |
|
|
| Sex/Gender, Customized | Number | Emergency department encounters | ED encounters |
|
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | Number | Emergency department encounters | ED encounters |
|
|
| Reason for clinic visit | A child could have multiple symptoms documented as the reason for the emergency department visit. | Number | Emergency department encounters | ED encounters |
|
|
| OG001 | Smartphone Otoscope Encounters | Emergency department 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. |
|
|
| 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. | Posted | Number | Emergency department encounters | Month 6 | Clinic encounters | Clinic 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. | Posted | Number | Emergency department encounters | Month 6 | Clinic encounters | Clinic 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. | Only participating clinicians who were randomized to use the smartphone otoscope were administered a survey at the end of the 6-month intervention. | Posted | Count of Participants | Participants | Month 6 |
|
|
|
| 0 |
| 776 |
| 0 |
| 776 |
| 0 |
| 776 |
| EG001 | Smartphone Otoscope Encounters | Emergency department 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. | 0 | 614 | 0 | 614 | 0 | 614 |
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| Title | Measurements |
|---|---|
|
| Congestion/runny nose |
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| Cough |
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| Other |
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| Title | Measurements |
|---|---|
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