Clinical evidence continuous medical education: randomised educational trial of an e-learning program for transferring evidence based information in primary and secondary care

ISRCTN ISRCTN27453314
DOI https://doi.org/10.1186/ISRCTN27453314
Secondary identifying numbers 43-06 SO
Submission date
26/03/2007
Registration date
25/04/2007
Last edited
05/03/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Lorenzo Moja
Scientific

Italian Cochrane Centre
Mario Negri Institute
Via La Masa 19
Milano
20156
Italy

Phone +39 02 3901 4517
Email moja@marionegri.it

Study information

Study designA before and after pragmatic educational randomised controlled trial utilising a two by two incomplete block design.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeDiagnostic
Scientific title
Study acronymICEKUBE (Italian Clinical Evidence Knowledge Utilisation Behaviour Evaluation)
Study objectivesThis trial is designed to test the effectiveness of ECCE (the Italian acronym for Continuing Education Clinical Evidence) e-learning program for transferring evidence based information to medical doctors after three months of ECCE usage and the retention of the transferred information after six months.
Ethics approval(s)The study was approved by the local research ethics committee (Research Ethics Board Azienda Sanitaria Locale “Città di Milano”, Milano) on the 15th December 2007 (ref: 43-06 SO).
Health condition(s) or problem(s) studiedKnowledge of the best available evidence for effective healthcare.
InterventionPlease note that as of 20/07/2007 the anticipated end date has been extended to 31/09/2007 due to a low recruitment rate. The previous end date of this trial was 31/07/2007. On 18/12/2007 the anticipated end date was extended again to 01/04/2008 due to a continued low recruitment rate. On the 05/03/2008 the anticipated end date was again amended to show the end date as the 29/02/2008 - this is the date this trial was closed to enrolment.

Sample size/power calculation:
Based on a preliminary examination, we determined that the “minimal” important difference for this intervention to be considered useful was a 20% absolute improvement.

Based on a preliminary test of 300 doctors, we determined that the “mean” improvement due to the intervention, was a 28% absolute improvement. Therefore we calculated our sample size to detect a 0.7 standardised difference in the primary outcome, set the α error rate at 0.05 (two-sided), and the β error at 0.10 (power 90%) – this yielded a sample size of 45 practitioners per study arm. If the accrual period is two months and the maximum follow-up period is six months with a loss during follow-up of 20% at the end of the study, the total number of practitioners to be randomised has been adjusted upwards to 162 (54 per intervention group).

Intervention:
ECCE is an e-learning tool that uses interactive clinical vignettes based on chapters in Clinical Evidence and a predefined sequence of questions. ECCE has four components:
1. The Clinical Evidence chapter (e.g. headache, chronic tension-type), a clinical vignette derived from the Clinical Evidence chapter gives a plausible medical scenario (e.g. Margaret says to her family doctor: “This time I didn’t come for me, but to talk about Rachel, my 25-year-old daughter…)
2. The lead-in for the clinical vignette and related questions that gives the doctors instructions on what to do (e.g. "more than one answer may be correct”)
3. The questions addressing the recall of Clinical Evidence facts or the application of Clinical Evidence facts to the medical scenario, based on which the doctor is to select the correct answer
4. And finally the potential answers (e.g. a list of potential efficacy descriptors for a therapeutic regimen relevant to the theme)

Group one access to ECCE for Clinical Evidence chapters and vignettes lot A and provides control data for Clinical Evidence chapters and vignettes lot B.
Group two access to ECCE for lot B and provides control data for lot A.

To determine the possible Hawthorne effect of this trial, we added to the two-block design arms a third control arm (classical design), in which a minimal intervention was defined. The minimal intervention consisted of one of the elements of the complete intervention, namely the concise printed version of Clinical Evidence and access to the on-line full-text version.
Intervention typeOther
Primary outcome measureThe primary outcome is the basic knowledge of Clinical Evidence contents assessed through the scoring of clinical vignettes selected from ECCE. The test will consist of fixed and multiple choice questions of the selected valid and reliable vignettes and will be administered before (pre-test), immediately after (12 weeks post-test one), and six months after the intervention (post-test two).
Secondary outcome measuresSatisfaction with the information source and its perceived value for the medical education and clinical practice.
Overall study start date05/04/2007
Completion date29/02/2008

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsA sample size of 54 practitioners per study arm
Key inclusion criteriaAll Italian doctors naïve to ECCE who voluntarily adhere to participate. New users to ECCE who connect to ECCE are automatically invited to participate.
Key exclusion criteriaThere are no exclusion criteria.
Date of first enrolment05/04/2007
Date of final enrolment29/02/2008

Locations

Countries of recruitment

  • Italy

Study participating centre

Italian Cochrane Centre
Milano
20156
Italy

Sponsor information

Italian Cochrane Centre (Italy)
Research organisation

c/o Dr Lorenzo Moja
Mario Negri Institute
Via La Masa 19
Milano
20156
Italy

Phone +39 02 3901 4517
Email moja@marionegri.it
Website http://www.icc.cochrane.org
ROR logo "ROR" https://ror.org/02d4c4y02

Funders

Funder type

Research organisation

Italian Drug Agency (AIFA) (Italy)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan