Condition category
Not Applicable
Date applied
07/06/2006
Date assigned
15/06/2006
Last edited
14/08/2008
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

Dto. Medicina Preventiva
Facultad de Medicina
C/ San Francisco S/N
Santiago
15783
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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 pharmacosurveillance system
3. Duration of the effect in terms of quantity and relevance could be more than one year

Ethics approval

In Portugal, educational interventions are not evaluated by ethical committees. In hospitals, it is the teaching committee that approves educational interventions. In communitarian pharmacies, we usually contact the pharmacist responsible by telephone.

Study design

Cluster-randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Under-reporting of adverse drug reactions

Intervention

We implemented a continuing medical education multifaceted intervention comprising of an outreach visit, reminder and report form. The main didactic material used for this purpose was a two-part presentation. The first part included definitions of pharmacosurveillance and adverse drug reaction, a number of international studies on morbidity and mortality, hospital admissions and the cost to health systems and patients, followed by the methods used in pharmacosurveillance and in spontaneous reporting systems in particular, explaining that underreporting constituted the system's principal limitation. The second part was designed to change the five attitudes identified by the previous case-control study as being associated with underreporting, and for this section we created animated pictures that depicted a physician’s daily work. Lastly, emphasis was laid on the fact that only five minutes was required to complete the report form. The control group clusters did not receive the intervention but, like those in the intervention group, did receive the briefing and standard training given by Portugal's northern pharmacovigilance unit.

Intervention type

Other

Phase

Not Specified

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

16/03/2004

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All National Health System physicians working in the Northern Region of Portugal and all pharmacists working in the same geographical area.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

6,451 physicians and 1,433 pharmacists

Participant exclusion criteria

Physicians not involved in any clinical activity (e.g. engaged in administrative tasks, analysis, etc.); working in substance abuse and rehabilitation centers; working at the regional pharmacosurveillance center or any department having a specific voluntary adverse drug reaction reporting program and physicians attached to specific hospitals (cancer, maternity, etc). Pharmacists working at the regional pharmacosurveillance center and attached to specific hospitals (cancer, maternity, etc).

Recruitment start date

16/03/2004

Recruitment end date

30/06/2005

Locations

Countries of recruitment

Portugal

Trial participating centre

Dto. Medicina Preventiva
Santiago
15783
Spain

Sponsor information

Organisation

Educational Development Program for Portugal (Programa de Desenvolvimento Educativo para Portugal) (PRODEP) (Portugal)

Sponsor details

Rua de Xabregas 52
Lisboa
1949-003
Portugal

Sponsor type

University/education

Website

http://www.prodep.min-edu.pt

Funders

Funder type

University/education

Funder name

Educational Development Programme for Portugal (Programa de Desenvolvimento Educativo para Portugal) (PRODEP) (Portugal)

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