Condition category
Injury, Occupational Diseases, Poisoning
Date applied
10/03/2011
Date assigned
13/09/2011
Last edited
13/09/2011
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 Teresa Herdeiro

ORCID ID

Contact details

Unidade de Farmacovigilância do Norte
Faculdade de Medicina
Universidade do Porto
Porto
4200
Portugal
teresaherdeiro@ua.pt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Improving adverse drug reaction reporting through workshops and telephone education in Portugal: a cluster randomised trial

Acronym

Study hypothesis

1. An educative intervention enhances the reporting rate of adverse drug reaction
2. An educative intervention enhances the quality of reporting, in terms of its relevance to the pharmacosurveillance system
3. Duration of the effect in terms of quality and relevance could be more than one year

Ethics approval

1. Northern Region Health Authority (ARS-Norte) approved on 12/03/2007
2. The ethical committees of hospitals for intervention group approved on 27/05/2007 and 21/01/2008

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Condition

Under-reporting adverse drug reactions

Intervention

We implemented a continuing medical education multifaceted intervention comprising of telephone interviews and workshops.

Telephone education consisted of a telephone conversation between the researcher and the physician conducted according to the established guidelines and supported by material sent to the participant, including one acknowledge letter, one adverse drug reaction (ADR) spontaneous notification form and one Northern Pharmacosurveillance Unit (UFN) presentation folder.

The workshops consisted of a brief presentation including presentations of pharmacosurveillance and ADRs and its impact in the public health, description of the methods used in pharmacosurveillance and in spontaneous reporting system and the aptitudes and knowledges of physicians about ADR spontaneous reporting.

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

01/01/2007

Overall trial end date

31/05/2009

Reason abandoned

Eligibility

Participant inclusion criteria

All National Health System physicians working in the northern region of Portugal

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6, 579 physicians

Participant exclusion criteria

1. Physicians not involved in any clinical activity (e.g. engaged in administrative tasks, analysis, etc.)
2. Working in substance abuse and rehabilitation centres
3. Working at the regional pharmacosurveillance centre or any department having a specific voluntary adverse drug reaction reporting program and physicians attached to specific hospitals (cancer, maternity, etc)

Recruitment start date

01/01/2007

Recruitment end date

31/05/2009

Locations

Countries of recruitment

Portugal

Trial participating centre

Unidade de Farmacovigilância do Norte
Porto
4200
Portugal

Sponsor information

Organisation

Northern Pharmacosurveillance Unit (Portugal)

Sponsor details

Unidade de Farmacovigilância do Norte
Faculdade de Medicina
Universidade do Porto
Porto
4200
Portugal
ufn@med.up.pt

Sponsor type

Government

Website

http://ufn.med.up.pt/

Funders

Funder type

Government

Funder name

Ministry of Science, Technology and Superior Education (Portugal)- Science and Technology Fund (Fundação para a Ciência e Tecnologia) (grant SFRH/BPD/35746/2007)

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