An educational intervention to improve adverse drug reactions reporting among Galician physicians
| ISRCTN | ISRCTN91140684 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91140684 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | N/A |
| Sponsor | Spanish Ministry of Health (Spain) |
| Funder | 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 |
- Submission date
- 07/05/2009
- Registration date
- 17/06/2009
- 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
Facultad de Medicina
C/ San Francisco s/n
Santiago de Compostela
15782
Spain
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Cluster-randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | An educational intervention to improve adverse drug reactions reporting: a cluster-randomised trial among Galician physicians |
| 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 pharmacovigilance system 3. Duration of the effect in terms of quality and relevance could be more than one year |
| Ethics approval(s) | Regional Ethical Committee in Galicia gave approval on the 20th December 2007 (ref: 2007/410) |
| Health condition(s) or problem(s) studied | 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 |
| 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 | 01/01/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 7498 |
| Total final enrolment | 7498 |
| Key inclusion criteria | All physicians working in the National Health System in Galicia (Spain) |
| Key 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 |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 01/01/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
Facultad de Medicina
Santiago de Compostela
15782
Spain
15782
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 | 01/02/2015 | 11/07/2019 | Yes | No |
Editorial Notes
11/07/2019: Publication reference and total final enrolment added.
