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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Dto. Medicina Preventiva
Facultad de Medicina
C/ San Francisco S/N
Santiago
15783
Spain
Study information
| Study design | Cluster-randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 16/03/2004 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 6,451 physicians and 1,433 pharmacists |
| 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
15783
Spain
Sponsor information
Educational Development Program for Portugal (Programa de Desenvolvimento Educativo para Portugal) (PRODEP) (Portugal)
University/education
University/education
Rua de Xabregas 52
Lisboa
1949-003
Portugal
| Website | http://www.prodep.min-edu.pt |
|---|
Funders
Funder type
University/education
Educational Development Programme for Portugal (Programa de Desenvolvimento Educativo para Portugal) (PRODEP) (Portugal)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
