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Educational Intervention in Pharmacovigilance for Hospital Health Professionals

NCT02134587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2023-06-05

Study results available
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Summary

Spontaneous reports by health professionals generate the signals in pharmacovigilance. However, the passive method has limitations and the most important of them are the underreporting and the poor quality of data, hindering the causality assessment of adverse drug events (ADE). Therefore, the present study aimed to validate an educational intervention (EI) in pharmacovigilance for hospital health professionals, in order to analyze the impact on the knowledge, skill and attitude in ADE reporting.

Investigators proposed a multifaceted EI which will be developed in four meetings with one hour each. The following activities will be carried out: application of a questionnaire to assess the knowledge, skill and attitude before and after EI; lecture; practical class and education material distribution. The answers of questionnaire are going to be analyzed using content analysis technique. The definitions of World Health Organization and the minimum and desired criteria to fill the ADE form, according to the Pan American Health Organization, are going to be considered gold-standard answers. The statistical test of Wilcoxon-Mann Whitney test for paired samples will be applied, in order to assess the impact of educational intervention on behavior of health professionals (ADE reporting).

With the present study, the following hypotheses will be tested:

H0= There is no difference between the numbers of ADE reported (behavior/attitudes) before and after the educational intervention.

H1= The numbers of ADE reported before and after the educational intervention are different.

Conditions

  • Adverse Drug Reaction

Interventions

OTHER

Multifaceted educational intervention

1. Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance. 2. Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3. Distribution of educational material 4. Practical class to explain the correct fill of adverse drug events form 5. Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance.

Sponsors & Collaborators

  • Universidade Estadual Paulista Júlio de Mesquita Filho

    lead OTHER

Principal Investigators

  • Patricia C Mastroianni, PhD · School of Pharmaceutical Sciences of Unesp

  • Fabiana R Varallo, Master · School of Pharmaceutical Sciences of Unesp

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2013-09-30
Completion
2014-05-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02134587 on ClinicalTrials.gov