Condition category
Not Applicable
Date applied
07/05/2009
Date assigned
17/06/2009
Last edited
17/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Adolfo Figueiras

ORCID ID

Contact details

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

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

http://www.msc.es

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

Publication citations

Additional files

Editorial Notes