An educational intervention to improve adverse drug reactions reporting among Galician physicians

ISRCTN ISRCTN91140684
DOI https://doi.org/10.1186/ISRCTN91140684
Secondary identifying numbers N/A
Submission date
07/05/2009
Registration date
17/06/2009
Last edited
11/07/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Adolfo Figueiras
Scientific

Facultad de Medicina
C/ San Francisco s/n
Santiago de Compostela
15782
Spain

Study information

Study designCluster-randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeDiagnostic
Scientific titleAn educational intervention to improve adverse drug reactions reporting: a cluster-randomised trial among Galician physicians
Study objectives1. An educative intervention enhances the rate of reporting adverse drug reaction
2. An educative intervention enhances the quality of reporting, in terms of its relevance to the pharmacovigilance system
3. Duration of the effect in terms of quality and relevance could be more than one year
Ethics approval(s)Regional Ethical Committee in Galicia gave approval on the 20th December 2007 (ref: 2007/410)
Health condition(s) or problem(s) studiedUnder-reporting of adverse drug reactions
InterventionWe implemented a continuing medical education multifaceted intervention comprising of a visit and report form. The main didactic material used for this purpose was a four-part presentation. The first part included definitions of pharmacovigilance and adverse drug reaction, a number of international studies on morbility and mortality, hospital admissions and the cost to health systems and patients, followed by the methods used in pharmacovigilance. During the second part, limitations of clinical trials for the detection of adverse drug reactions are explained as well as the advantages of the spontaneous reporting systems, explaining that under-reporting constituted the system's principal limitation. The third part was designed to change the five attitudes identified by a previous case-control study as being associated with under-reporting (complacency, insecurity, diffidence, indifference and ignorance). Another study carried out in Galicia was also taken into account; in this last study four attitudes were identified: complacency, insecurity, diffidence and indifference. Then, emphasis was laid on the fact that only five minutes was required to complete the report form. Finally, it was explained how to report to the Galician Regional Pharmacovigilance Centre. The control group clusters received regular information provided by the Galician Regional Pharmacovigilance Centre but not the intervention.

Joint sponsor details:
Consellería de Sanidade e Servizo Galego de Saúde (Spain)
Edificio Administrativo de San Lázaro
15781 Santiago de Compostela
Spain
Intervention typeOther
Primary outcome measureRate of total notifications per month.
Secondary outcome measuresRate of serious, unexpected, high-causality and new-drug-related adverse drug reactions per month.
Overall study start date01/10/2007
Completion date01/01/2011

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants7498 physicians
Total final enrolment7498
Key inclusion criteriaAll physicians working in the National Health System in Galicia (Spain)
Key exclusion criteria1. Not involved in clinical activities (e.g. analysis, administrative tasks, genetics, etc.)
2. Working in drug abuse rehabilitation centres
3. Working at the Regional Pharmacovigilance Centre or in any other unit that has a special programme for the reporting of adverse drug reactions
Date of first enrolment01/10/2007
Date of final enrolment01/01/2011

Locations

Countries of recruitment

  • Spain

Study participating centre

Facultad de Medicina
Santiago de Compostela
15782
Spain

Sponsor information

Spanish Ministry of Health (Spain)
Government

Paseo del Prado 18
Madrid
28014
Spain

Website http://www.msc.es
ROR logo "ROR" https://ror.org/00y6q9n79

Funders

Funder type

Government

Collaboration agreement between the Spanish Ministry of Health (Spain) and the Galician Regional Government (Spain) for the promotion of safety practices in health care facilities

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

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2015 11/07/2019 Yes No

Editorial Notes

11/07/2019: Publication reference and total final enrolment added.