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Trial registered on ANZCTR
Registration number
ACTRN12609000022268
Ethics application status
Approved
Date submitted
30/10/2008
Date registered
12/01/2009
Date last updated
12/01/2009
Type of registration
Retrospectively registered
Titles & IDs
Public title
A cluster randomised controlled trial to evaluate the effectiveness of an e-based clinically integrated basic Evidence Based Medicine (EBM) course
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Scientific title
The effectivenss of a clinically integrated e-learning course compared to traditional lecture based course to improve knowledge, skills and attitudes towards evidence based medicine in junior medical doctors
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Improvement of knowledge, skills and attitudes towards evidence based medicine
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Condition category
Condition code
Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Clinically integrated e-learning based course
The curriculum is subdivided into five modules each of which addresses core competencies in evidence-based practice. These modules are:
1. Asking and framing clinical questions.
2. Searching for the evidence
3a. Critical appraisal of primary randomised controlled trials
3b. Measures of effectiveness
3c. Critical appraisal of systematic reviews of intervention studies
4. Applicability of the evidence to the patient
5. Implementation of the evidence into practice
Each module consists of self-directed e-learning sessions, clinically integrated learning and teaching activities and pre-and post course assessment (multiple choice questions) and are taught consecutively over a period of 5-6 weeks.
The e-learning sessions provide the theoretical knowledge for each module. Each session takes about 20 -30 minutes to complete
A facilitator guides the learner through the course and helps identifying learning opportunities in a clinical setting, during ward rounds and daily meetings and to apply the gained knowledge to a clinical case scenario.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
Traditional lecture based course
Five lectures, with the same learning objectives and content as the e-sessions in the intervention group, are being delivered to the learners over 5-6 weeks by a tutor (using power point presentations). Each lecture takes around 30 -60 minutes.
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Control group
Active
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Outcomes
Primary outcome [1]
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knowledge, skills.
These will be measured by multiple choice questionnaires applied pre-and postcourse
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Assessment method [1]
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Timepoint [1]
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Pre and post intervention/control data collection.
Multiple choice questions will be applied immediately before start of each (intervention and control) group and immediately after completing the course
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Secondary outcome [1]
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attitude & behaviour
Both will be measured immediately before start and immediately after completing the course via pre-validated questionnaire
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Assessment method [1]
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Timepoint [1]
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pre and post intervention/control data collection.
Immediately before start of the course and immediately after completing the course
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Eligibility
Key inclusion criteria
junior medical doctors during the first year of residency
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
key exclusion criteria:
senior medical trainees
unwilling to participate
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/08/2007
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
8
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
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United Kingdom
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State/province [1]
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Funding & Sponsors
Funding source category [1]
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Government body
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Name [1]
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European Union Leonardo da Vinci vocational training project
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Address [1]
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The University of Birmingham, Edgbaston, Birmingham B15 2TG
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Country [1]
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United Kingdom
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Primary sponsor type
Government body
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Name
European Union Leonardo da Vinci vocational training project
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Address
The University of Birmingham, Edgbaston, Birmingham B15 2TG
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Country
United Kingdom
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Summary
Brief summary
A randomised controlled trial, comparing an ‘on-the job’, clinically integrated learning approach with a traditional lecture-based approach to teach evidence-based medicine in the postgraduate, medical setting.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Regina Kulier
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Address
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Birmingham University
Edgbaston
Birmingham/UK
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Country
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United Kingdom
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Phone
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+44(0)1214143344
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Regina Kulier
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Address
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The University of Birmingham, Edgbaston, Birmingham B15 2TG
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Country
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United Kingdom
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Phone
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+44(0)1214143344
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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