Recruitment

Recruitment Status
Completed

Summary

Conditions
Adverse Drug Reaction
Type
Interventional
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

Description

A quasi-experimental study with health professionals who acted in a general and public hospital of medium complexity with 104 beds will be performed. Investigators proposed an educational intervention, with the development of lecture and practical class, application of questionnaire before and after...

A quasi-experimental study with health professionals who acted in a general and public hospital of medium complexity with 104 beds will be performed. Investigators proposed an educational intervention, with the development of lecture and practical class, application of questionnaire before and after EI and the distribution of educational material. Activities will be developed in four meetings of one hour each one. In the first meeting, questionnaire will be applied, in order to assess knowledge, skills and attitudes in pharmacovigilance prior to EI. The instrument was elaborated based on previous studies. Second meeting will be comprise a lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material, whose content includes the same issues of presentation. In the third meeting, a practical class will be performed to promote a discussion of a fictitious case of adverse drug reaction (ADR), in order to elucidate the correct fill of ADE form. In the fourth meeting, will be repeated the application of questionnaire, in order to assess the impact of EI. With the aim to verify change behavior of health professionals regarding pharmacovigilance activities, the number of ADE reports made prior and after intervention will be compared.

Locations

Américo Brasiliense, São Paulo, 14820-000
Américo Brasiliense, São Paulo, 14820-000

Tracking Information

NCT #
NCT02134587
Collaborators
Not Provided
Investigators
  • Study Chair: Patricia C Mastroianni, PhD School of Pharmaceutical Sciences of Unesp Principal Investigator: Fabiana R Varallo, Master School of Pharmaceutical Sciences of Unesp
  • Study Chair: Patricia C Mastroianni, PhD School of Pharmaceutical Sciences of Unesp Fabiana R Varallo, Master School of Pharmaceutical Sciences of Unesp