Ear InfectionNCT03101605
E-learning on the Trainees' Ability to Diagnose and Treat Acute Otitis Media Among Children
A study testing e-learning teaching module and Standard teaching method in people with Ear Infection, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
An e-learning module to teach how to evaluate ears in children was recently designed. The aim of this study is to measure the impact of this e-learning module on the trainees' ability to appropriately diagnose ear infection in clinical setting. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ear Infection
- What is being tested?
- e-learning teaching module and Standard teaching method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jun 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Third or fourth-year medical students
- Doing their 6-week rotation in general pediatrics at Sainte-Justine Hospital
- Participation at the introductory meeting on the first day of the rotation
Who cannot join
- No shifts scheduled at the emergency department during general pediatrics rotation
- Student already recruited in a previous rotation
- Student who evaluated less than 10 ears for the study will not be included in the primary analysis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of E-learning on the Trainees' Ability to Diagnose and Treat Acute Otitis Media Among Children; A Randomized Educational Trial
An e-learning module to teach how to evaluate ears in children was recently designed. The aim of this study is to measure the impact of this e-learning module on the trainees' ability to appropriately diagnose ear infection in clinical setting.
Read the detailed description
Background and aims: Acute Otitis Media (AOM) is one of the most common infections of childhood and a leading cause for antibiotics prescription. In a previous study performed at a tertiary care pediatric emergency department, residents were found to have as low as a 52% sensitivity and 74% specificity for the diagnosis of AOM. Seeing this as an opportunity for substantial improvement, an e-learning module on AOM intended for medical students was designed. The primary objective of this study is to measure the impact of this e-learning module on the trainees' ability to appropriately diagnose AOM. The secondary objectives are to assess the preferred learning modality, to evaluate if our e-learning module is associated with improved knowledge on AOM and with better retention at 3 weeks.
Methods: This will be a randomized trial performed at a single tertiary care pediatric emergency department. The participants will be third- and fourth-year medical students doing a general pediatrics rotation. The participants will be randomized to completing the e-learning module at the beginning of their rotation or to receive a 2-hour lecture on the topic of AOM. The primary outcome will be ear examination accuracy measured during their shifts at the emergency department. To measure this, participants will be asked to examine a minimum of five children at risk for AOM, defined as 12-60 months old of age with fever or respiratory symptoms. They will be questioned about the presence or absence of AOM in each examined ear. Attending physicians will control all exams and write down their diagnosis. The primary analysis will be the difference in diagnostic accuracies between the trainees who completed the E-learning module and those who received the lecture. A sample size of 80 medical students each examining a minimum of five children would provide a power of 90% and an alpha-value of 0,05 to demonstrate a difference of 15% in the AOM diagnostic accuracies of medical students who have completed an E-learning module on AOM compared with those receiving a standard lecture on the same topic.
- Conditions
- Ear Infection
- Being tested
- e-learning teaching module, Standard teaching method
- Medical subject headings
- Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-learning teaching moduleOther
As described
Standard teaching methodOther
As described
| Study group | Role | What they receive |
|---|---|---|
| e-learning | Experimental | The intervention for this study will be the completion of an original E-learning module on AOM designed by a team of pediatric residents, pediatricians, a pediatric otolaryngologist, a pediatric emergency physician and a pediatric infectious diseases specialist. The module includes interactive sections on anatomy, epidemiology, pathophysiology, microbiology, diagnostic criteria, treatment options and prognosis. A 5 minute video demonstrating appropriate pediatric ear examination techniques is also included in the module. Throughout the module, many examples of ear pathologies captured on video during a previous study. The E-learning module should take 0.5 hr to complete. Receives: Other: e-learning teaching module |
| Standard teaching | Other | The control group will receive a 2h lecture on AOM, which is the "standard" teaching method. Given by a pediatrician or a senior pediatric resident, this lecture, using a PowerPoint© presentation support, encompasses clinical cases, notions of anatomy, epidemiology, pathophysiology, diagnostic criteria, treatment options, and prognosis, describes different ear examination techniques, and shows examples of different pathologies. Receives: Other: Standard teaching method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ear exam accuracy
accuracy of diagnosis of acute otitis media in comparison to the diagnosis made by a staff working at the pediatric emergency
Measured: 1 month
Secondary outcomes (3)
Favorite teaching method
preferred learning modality according to the learners
Measured: 1 month
Immediate theoretical knowledge
Total score in a local knowledge evaluation test composed of the interpretation of 15 ear videos and 5 multiple questions on AOM immediately following training
Measured: 1 hour post training
remote theoretical knowledge
Total score in a local knowledge evaluation test composed of the evaluation of 15 ear videos and 5 multiple questions on AOM immediately following training
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start15 Jun 2017
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ear InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jocelyn Gravel, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03101605
- Sponsor's protocol ID
- E-learning for ear exam
- Status last verified
- Apr 2019
- First submitted
- 24 Mar 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of E-learning on the Trainees' Ability to Diagnose and Treat Acute Otitis Media Among Children; A Randomized Educational Trial
- ClinicalTrials.gov ID
- NCT03101605
- Acronym / sponsor ID
- E-learning for ear exam
- Conditions
- Ear Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An e-learning module to teach how to evaluate ears in children was recently designed. The aim of this study is to measure the impact of this e-learning module on the trainees' ability to appropriately diagnose ear infection in clinical setting.
Detailed description
Background and aims: Acute Otitis Media (AOM) is one of the most common infections of childhood and a leading cause for antibiotics prescription. In a previous study performed at a tertiary care pediatric emergency department, residents were found to have as low as a 52% sensitivity and 74% specificity for the diagnosis of AOM. Seeing this as an opportunity for substantial improvement, an e-learning module on AOM intended for medical students was designed. The primary objective of this study is to measure the impact of this e-learning module on the trainees' ability to appropriately diagnose AOM. The secondary objectives are to assess the preferred learning modality, to evaluate if our e-learning module is associated with improved knowledge on AOM and with better retention at 3 weeks.
Methods: This will be a randomized trial performed at a single tertiary care pediatric emergency department. The participants will be third- and fourth-year medical students doing a general pediatrics rotation. The participants will be randomized to completing the e-learning module at the beginning of their rotation or to receive a 2-hour lecture on the topic of AOM. The primary outcome will be ear examination accuracy measured during their shifts at the emergency department. To measure this, participants will be asked to examine a minimum of five children at risk for AOM, defined as 12-60 months old of age with fever or respiratory symptoms. They will be questioned about the presence or absence of AOM in each examined ear. Attending physicians will control all exams and write down their diagnosis. The primary analysis will be the difference in diagnostic accuracies between the trainees who completed the E-learning module and those who received the lecture. A sample size of 80 medical students each examining a minimum of five children would provide a power of 90% and an alpha-value of 0,05 to demonstrate a difference of 15% in the AOM diagnostic accuracies of medical students who have completed an E-learning module on AOM compared with those receiving a standard lecture on the same topic.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| e-learning | Experimental | Other: e-learning teaching moduleThe intervention for this study will be the completion of an original E-learning module on AOM designed by a team of pediatric residents, pediatricians, a pediatric otolaryngologist, a pediatric emergency physician and a pediatric infectious diseases specialist. The module includes interactive sections on anatomy, epidemiology, pathophysiology, microbiology, diagnostic criteria, treatment options and prognosis. A 5 minute video demonstrating appropriate pediatric ear examination techniques is also included in the module. Throughout the module, many examples of ear pathologies captured on video during a previous study. The E-learning module should take 0.5 hr to complete. |
| Standard teaching | Other | Other: Standard teaching methodThe control group will receive a 2h lecture on AOM, which is the "standard" teaching method. Given by a pediatrician or a senior pediatric resident, this lecture, using a PowerPoint© presentation support, encompasses clinical cases, notions of anatomy, epidemiology, pathophysiology, diagnostic criteria, treatment options, and prognosis, describes different ear examination techniques, and shows examples of different pathologies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Third or fourth-year medical students
- Doing their 6-week rotation in general pediatrics at Sainte-Justine Hospital
- Participation at the introductory meeting on the first day of the rotation
Key exclusion criteria (3 listed)
- No shifts scheduled at the emergency department during general pediatrics rotation
- Student already recruited in a previous rotation
- Student who evaluated less than 10 ears for the study will not be included in the primary analysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-learning teaching moduleAs described | Other | e-learning |
| Standard teaching methodAs described | Other | Standard teaching |
Primary outcome
Ear exam accuracy
Time frame: 1 month
accuracy of diagnosis of acute otitis media in comparison to the diagnosis made by a staff working at the pediatric emergency
3 secondary outcomes
Favorite teaching method
Time frame: 1 month
Immediate theoretical knowledge
Time frame: 1 hour post training
remote theoretical knowledge
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-learning teaching module and Standard teaching method in people with Ear Infection, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ear exam accuracy (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2019.