Trial Outcomes & Findings for Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto) (NCT NCT02918773)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Month 6

Results posted on

2018-07-13

Participant Flow

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.

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.

Unit of analysis: Emergency department encounters

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	11 776	11 614
Overall Study COMPLETED	11 776	11 614
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The age of one child in the smartphone otoscope group is unknown.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Conventional Otoscope Encounters n=776 ED 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.	Smartphone Otoscope Encounters n=614 ED 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.	Total n=1390 ED encounters Total of all reporting groups
Age, Continuous	43.5 age in months of encounter subjects STANDARD_DEVIATION 38.8 • n=776 ED encounters • The age of one child in the smartphone otoscope group is unknown.	49.0 age in months of encounter subjects STANDARD_DEVIATION 42.0 • n=613 ED encounters • The age of one child in the smartphone otoscope group is unknown.	45.90 age in months of encounter subjects STANDARD_DEVIATION 40.34 • n=1389 ED encounters • The age of one child in the smartphone otoscope group is unknown.
Sex/Gender, Customized Not collected	776 Emergency department encounters n=776 ED encounters	614 Emergency department encounters n=614 ED encounters	1390 Emergency department encounters n=1390 ED encounters
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	776 Emergency department encounters n=776 ED encounters	614 Emergency department encounters n=614 ED encounters	1390 Emergency department encounters n=1390 ED encounters
Reason for clinic visit Fever	522 Emergency department encounters n=776 ED encounters	424 Emergency department encounters n=614 ED encounters	946 Emergency department encounters n=1390 ED encounters
Reason for clinic visit Ear pain	106 Emergency department encounters n=776 ED encounters	96 Emergency department encounters n=614 ED encounters	202 Emergency department encounters n=1390 ED encounters
Reason for clinic visit Congestion/runny nose	270 Emergency department encounters n=776 ED encounters	182 Emergency department encounters n=614 ED encounters	452 Emergency department encounters n=1390 ED encounters
Reason for clinic visit Cough	365 Emergency department encounters n=776 ED encounters	274 Emergency department encounters n=614 ED encounters	639 Emergency department encounters n=1390 ED encounters
Reason for clinic visit Other	338 Emergency department encounters n=776 ED encounters	317 Emergency department encounters n=614 ED encounters	655 Emergency department encounters n=1390 ED encounters

PRIMARY outcome

Timeframe: Month 6

Population: This analysis includes emergency department encounters with children by a participating clinician where AOM was diagnosed.

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.

Outcome measures

Outcome measures
Measure	Conventional Otoscope Encounters n=146 Number of 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.	Smartphone Otoscope Encounters n=123 Number of 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.
Number of Antibiotic Prescriptions Antibiotic prescribed	140 Emergency department encounters	115 Emergency department encounters
Number of Antibiotic Prescriptions Antibiotic not prescribed	6 Emergency department encounters	7 Emergency department encounters
Number of Antibiotic Prescriptions Unknown	0 Emergency department encounters	1 Emergency department encounters

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Conventional Otoscope Encounters n=776 Clinic 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.	Smartphone Otoscope Encounters n=614 Clinic 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.
Number of Diagnoses of Acute Otitis Media (AOM) AOM Diagnosed	146 Emergency department encounters	123 Emergency department encounters
Number of Diagnoses of Acute Otitis Media (AOM) AOM Not Diagnosed	630 Emergency department encounters	491 Emergency department encounters

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Conventional Otoscope Encounters n=776 Clinic 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.	Smartphone Otoscope Encounters n=614 Clinic 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.
Number of Diagnoses of Otitis Externa Otitis Externa Diagnosed	0 Emergency department encounters	0 Emergency department encounters
Number of Diagnoses of Otitis Externa Otitis Externa Not Diagnosed	776 Emergency department encounters	614 Emergency department encounters

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Conventional Otoscope Encounters n=11 Participants 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.	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.
Clinician Acceptability of the Smartphone Otoscopic Device Preferred smartphone over conventional otoscope	8 Participants	—
Clinician Acceptability of the Smartphone Otoscopic Device Smartphone increased ability to diagnose AOM	3 Participants	—
Clinician Acceptability of the Smartphone Otoscopic Device Smartphone did not impact antibiotic prescribing	6 Participants	—

Adverse Events

Conventional Otoscope Encounters

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smartphone Otoscope Encounters

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andi L Shane MD/MPH/MSc

Emory University

Phone: 404-727-9880

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place