Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
An educational intervention to improve adverse drug reactions reporting: a cluster-randomised trial among Galician physicians
Acronym
Study hypothesis
1. 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
Regional Ethical Committee in Galicia gave approval on the 20th December 2007 (ref: 2007/410)
Study design
Cluster-randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Diagnostic
Patient information sheet
Condition
Under-reporting of adverse drug reactions
Intervention
We 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 type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Rate of total notifications per month.
Secondary outcome measures
Rate of serious, unexpected, high-causality and new-drug-related adverse drug reactions per month.
Overall trial start date
01/10/2007
Overall trial end date
01/01/2011
Reason abandoned
Eligibility
Participant inclusion criteria
All physicians working in the National Health System in Galicia (Spain)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
7498 physicians
Participant exclusion criteria
1. 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
Recruitment start date
01/10/2007
Recruitment end date
01/01/2011
Locations
Countries of recruitment
Spain
Trial participating centre
Facultad de Medicina
Santiago de Compostela
15782
Spain
Sponsor information
Organisation
Spanish Ministry of Health (Spain)
Sponsor details
Paseo del Prado 18
Madrid
28014
Spain
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
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
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary