- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03101605
E-learning on the Trainees' Ability to Diagnose and Treat Acute Otitis Media Among Children
Impact of E-learning on the Trainees' Ability to Diagnose and Treat Acute Otitis Media Among Children; A Randomized Educational Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T1C5
- Sainte-Justine Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: e-learning
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.
|
As described
|
Other: Standard teaching
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.
|
As described
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Favorite teaching method
Time Frame: 1 month
|
preferred learning modality according to the learners
|
1 month
|
Immediate theoretical knowledge
Time Frame: 1 hour post training
|
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
|
1 hour post training
|
remote theoretical knowledge
Time Frame: 1 month
|
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
|
1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-learning for ear exam
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ear Infection
-
University of California, IrvineNational Institute on Deafness and Other Communication Disorders (NIDCD)Recruiting
-
University of California, IrvineBeckman Laser Institute University of California IrvineWithdrawnMiddle Ear Infection
-
Baylor College of MedicineActive, not recruitingOtitis Media | Middle Ear Infection | Ear InfectionUnited States
-
Centre Hospitalier Universitaire DijonUnknownEpidemiology | Achromobacter | Chronic Ear InfectionFrance
-
Sunnybrook Health Sciences CentreEnrolling by invitationSurgical Site Infection | Antibiotic Side Effect | Ear Infection BacterialCanada
-
AventaMed DACRecruiting
-
AventaMed DACActive, not recruiting
-
Preceptis Medical, Inc.CompletedOtitis Media | Ear InfectionUnited States
-
AventaMed DACUnknownOtitis Media | Ear InfectionUnited Kingdom, Italy
-
National Center for Complementary and Integrative...CompletedNervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in ChildrenOtitis MediaUnited States
Clinical Trials on e-learning teaching module
-
Althaia Xarxa Assistencial Universitària de ManresaSpanish Society of Digestive Endoscopy; Fundació La Marató de TV3; Asociación...RecruitingColorectal Cancer | Colorectal Cancer Stage ISpain, United States, Japan, United Kingdom
-
Bethany RhotenActive, not recruiting
-
Maharishi Markendeswar University (Deemed to be...Completed
-
RSUP FatmawatiRecruitingLearning Module | Cognitive Non-technical SkillsIndonesia
-
Hôpital du ValaisCompleted
-
Antoine FourréUniversiteit Antwerpen; University of Mons; University of Picardie Jules VerneCompletedLow Back Pain | Physical Therapy | Knowledge, Attitudes, Practice | PhysiciansBelgium
-
Safa Hamdy Alkalash AlsayedMansoura UniversityCompleted
-
Ruhr University of BochumUniversity of Cologne; University of Koblenz-Landau; Philipps Universität MarburgCompletedDiagnosis, PsychiatricGermany
-
Youngstown State UniversityCompleted
-
University GhentCompletedVascular DiseaseBelgium