Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000198224
Ethics application status
Approved
Date submitted
11/03/2009
Date registered
21/04/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A cluster randomized controlled trial to evaluate the effectiveness of the clinically integrated Reproductive Health Library (RHL) evidence -based medicine course
Scientific title
Clinically integrated teaching versus dissemination of worksop-based materials to improve knowledge, skills and competencies for evidence-based medicine in junior obstetrics and gynaecology trainees.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Educating junior obstetrics and gynaecology trainees to improve knowledge, skills and competencies for evidence-based medicine 4454 0
Condition category
Condition code
Other 4723 4723 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention consists of a curriculum with 5 modules, tought and learned over a period of 8 weeks. Assessments are pre and one month post intervention. The modules are: 1) asking clinical questions, 2) searching the evidence, 3) critical appraisal of systematic reviews, 4)applicability of the evidence to the patient, 5) implementation of the evidence into practice. Each module consists of an e-learning component (these are one to three 15-25 minutes online sessions for the trainee to complete in her/his own time), applying the theoretical knowledge during clinical wardrounds and formative and summative assessments.
A clinical facilitator guides trainees to
identifying learning opportunities in a clinical setting, directs appropriate use of learning resources (e-learning) and providies feedback on learning exercises/assignments.
Trainees will pursue independent study using the study guide and e-learning modules.
Intervention code [1] 4199 0
Other interventions
Comparator / control treatment
The control intervention consits of online disseminated evidence based medicine (EBM) resources from the World Health Organization Reproductive Health Library (WHO RHL) workshop-based course with the same learning objectives as the intervention. The materials include 6 powerpoint presentations with additional text that describes the process and contains explanatory information. Learning is self-directed; the 6 modules have to be taken in sequence over a period of 8 weeks; summative assessments are pre-and post intervention.The content of the presentations are similar to the content of the RHL-EBM Course. The powerpoint presentations focus on;
1) formulating clinical answerable questions.
2)searching effectively for evidence using tools such as the Reproductive Health Library and the Cochrane Library
3)critically appraise clinical evidence for its validity and applicability
4) understanding basic effect measures such as Relative Risk and Numbers Needed to Treat
Control group
Active

Outcomes
Primary outcome [1] 5591 0
Gain in evidence-based medicine knowledge: measured by using multiple choice questions
Timepoint [1] 5591 0
pre -and post ( one month after completion of either intervention or control course)
Primary outcome [2] 5763 0
change in attitude towards evidence-based medicine: measured by using multiple choice questions
Timepoint [2] 5763 0
pre -and post ( one month after completion of either intervention or control course)
Primary outcome [3] 5764 0
skills competence in applying evidence-based medicine principles: measured by using adapted objective structured clinical questions (OSCE)
Timepoint [3] 5764 0
one month after completion of either intervention or control course
Secondary outcome [1] 241719 0
educational environment towards evidence-based medicine (EBMEEM): measured by using multiple choice questions
Timepoint [1] 241719 0
pre -and post ( one month after completion of either intervention or control course)

Eligibility
Key inclusion criteria
Participants are training institutions in obstetrics and gynaecology in the participating countries. Hospitals belonging to the same training institution will form the cluster. Trainees are junior doctors in obstetrics and gynaecology training with no previous formal evidence-based medicine training.
Minimum age
N/A
Maximum age
N/A
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
units with:
<4 junior residents in training
no suitable facilitator/trainees agreeing to participate
computer/internet facilities inadequate
declining 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
Recruiting
Date of first participant enrolment
Anticipated
1/03/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 1667 0
Argentina
State/province [1] 1667 0
Country [2] 1668 0
Brazil
State/province [2] 1668 0
Country [3] 1669 0
Congo, The Democratic Republic Of The
State/province [3] 1669 0
Country [4] 1670 0
India
State/province [4] 1670 0
Country [5] 1671 0
Philippines
State/province [5] 1671 0
Country [6] 1672 0
South Africa
State/province [6] 1672 0
Country [7] 1673 0
Thailand
State/province [7] 1673 0

Funding & Sponsors
Funding source category [1] 4645 0
Charities/Societies/Foundations
Name [1] 4645 0
World Health Organization - Department of Reproductive Health and Research
Country [1] 4645 0
Switzerland
Primary sponsor type
Charities/Societies/Foundations
Name
World Health Organization; Department of Reproductive Health and Research
Address
via appia 20
1202 Geneva
Country
Switzerland
Secondary sponsor category [1] 4348 0
None
Name [1] 4348 0
Address [1] 4348 0
Country [1] 4348 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6684 0
Research Ethics Review Committee (WHO ERC)
Ethics committee address [1] 6684 0
Ethics committee country [1] 6684 0
Switzerland
Date submitted for ethics approval [1] 6684 0
Approval date [1] 6684 0
04/07/2008
Ethics approval number [1] 6684 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29380 0
Address 29380 0
Country 29380 0
Phone 29380 0
Fax 29380 0
Email 29380 0
Contact person for public queries
Name 12627 0
AM Gülmezoglu
Address 12627 0
Department of Reproductive Health and Research, World Health Organization
via appia 20
1202 Geneva
Country 12627 0
Switzerland
Phone 12627 0
+41-22-791 3417
Fax 12627 0
Email 12627 0
[email protected]
Contact person for scientific queries
Name 3555 0
AM Gülmezoglu
Address 3555 0
Department of Reproductive Health and Research, World Health Organization
via appia 20
1202 Geneva
Country 3555 0
Switzerland
Phone 3555 0
+41-22-791 3417
Fax 3555 0
Email 3555 0
[email protected]

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.