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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
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
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Improvement of knowledge, skills and attitudes towards evidence based medicine 3899 0
Condition category
Condition code
Other 4097 4097 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 3625 0
Other interventions
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.
Control group
Active

Outcomes
Primary outcome [1] 4991 0
knowledge, skills.
These will be measured by multiple choice questionnaires applied pre-and postcourse
Timepoint [1] 4991 0
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
Secondary outcome [1] 8427 0
attitude & behaviour
Both will be measured immediately before start and immediately after completing the course via pre-validated questionnaire
Timepoint [1] 8427 0
pre and post intervention/control data collection.
Immediately before start of the course and immediately after completing the course

Eligibility
Key inclusion criteria
junior medical doctors during the first year of residency
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
key exclusion criteria:
senior medical trainees
unwilling to participate

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1311 0
United Kingdom
State/province [1] 1311 0

Funding & Sponsors
Funding source category [1] 4090 0
Government body
Name [1] 4090 0
European Union Leonardo da Vinci vocational training project
Address [1] 4090 0
The University of Birmingham, Edgbaston, Birmingham B15 2TG
Country [1] 4090 0
United Kingdom
Primary sponsor type
Government body
Name
European Union Leonardo da Vinci vocational training project
Address
The University of Birmingham, Edgbaston, Birmingham B15 2TG
Country
United Kingdom
Secondary sponsor category [1] 3683 0
None
Name [1] 3683 0
Address [1] 3683 0
Country [1] 3683 0

Ethics approval
Ethics application status
Approved

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29081 0
Address 29081 0
Country 29081 0
Phone 29081 0
Fax 29081 0
Email 29081 0
Contact person for public queries
Name 12238 0
Regina Kulier
Address 12238 0
Birmingham University
Edgbaston
Birmingham/UK
Country 12238 0
United Kingdom
Phone 12238 0
+44(0)1214143344
Fax 12238 0
Email 12238 0
r.kulier@bham.ac.uk
Contact person for scientific queries
Name 3166 0
Regina Kulier
Address 3166 0
The University of Birmingham, Edgbaston, Birmingham B15 2TG
Country 3166 0
United Kingdom
Phone 3166 0
+44(0)1214143344
Fax 3166 0
Email 3166 0
r.kulier@bham.ac.uk

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary