An educational intervention to improve adverse drug reactions reporting: a cluster-randomised trial among Portuguese physicians and pharmacists

ISRCTN	ISRCTN45894687
DOI	https://doi.org/10.1186/ISRCTN45894687
Protocol serial number	N/A
Sponsor	Educational Development Program for Portugal (Programa de Desenvolvimento Educativo para Portugal) (PRODEP) (Portugal)
Funder	Educational Development Programme for Portugal (Programa de Desenvolvimento Educativo para Portugal) (PRODEP) (Portugal)

Submission date: 07/06/2006
Registration date: 15/06/2006
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

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

Study information

Primary study design	Interventional
Study design	Cluster-randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title	An educational intervention to improve adverse drug reactions reporting: a cluster-randomised trial among Portuguese physicians and pharmacists
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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 physicians 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
Primary outcome measure(s)	Rate of total notifications per month
Key secondary outcome measure(s)	Rate of serious, unexpected, high-causality, and new-drug-related adverse drug reactions per month
Completion date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	7884
Total final enrolment	1433
Key inclusion criteria	All National Health System physicians working in the Northern Region of Portugal and all pharmacists working in the same geographical area.
Key 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).
Date of first enrolment	16/03/2004
Date of final enrolment	30/06/2005

Locations

Countries of recruitment

Portugal
Spain

Study participating centre

Dto. Medicina Preventiva

Santiago
15783
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2008	11/07/2019	Yes	No

Editorial Notes

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