Educational Intervention in Pharmacovigilance for Hospital Health Professionals
NCT ID: NCT02134587
Last Updated: 2023-06-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
203 participants
INTERVENTIONAL
2012-02-29
2014-05-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Subjects post educational intervention
Multifaceted educational intervention in pharmacovigilance
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Universidade Estadual Paulista Júlio de Mesquita Filho
OTHER
Responsible Party
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Fabiana Rossi Varallo
Clinical pharmacist and PhD student
Principal Investigators
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Patricia C Mastroianni, PhD
Role: STUDY_CHAIR
School of Pharmaceutical Sciences of Unesp
Fabiana R Varallo, Master
Role: PRINCIPAL_INVESTIGATOR
School of Pharmaceutical Sciences of Unesp
Locations
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Hospital Estadual Américo Brasiliense
Américo Brasiliense, São Paulo, Brazil
Countries
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References
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Figueiras A, Tato F, Fontainas J, Gestal-Otero JJ. Influence of physicians' attitudes on reporting adverse drug events: a case-control study. Med Care. 1999 Aug;37(8):809-14. doi: 10.1097/00005650-199908000-00010.
Herdeiro MT, Figueiras A, Polonia J, Gestal-Otero JJ. Physicians' attitudes and adverse drug reaction reporting : a case-control study in Portugal. Drug Saf. 2005;28(9):825-33. doi: 10.2165/00002018-200528090-00007.
Herdeiro MT, Figueiras A, Polonia J, Gestal-Otero JJ. Influence of pharmacists' attitudes on adverse drug reaction reporting : a case-control study in Portugal. Drug Saf. 2006;29(4):331-40. doi: 10.2165/00002018-200629040-00004.
Gerritsen R, Faddegon H, Dijkers F, van Grootheest K, van Puijenbroek E. Effectiveness of pharmacovigilance training of general practitioners: a retrospective cohort study in the Netherlands comparing two methods. Drug Saf. 2011 Sep 1;34(9):755-62. doi: 10.2165/11592800-000000000-00000.
Pedros C, Vallano A, Cereza G, Mendoza-Aran G, Agusti A, Aguilera C, Danes I, Vidal X, Arnau JM. An intervention to improve spontaneous adverse drug reaction reporting by hospital physicians: a time series analysis in Spain. Drug Saf. 2009;32(1):77-83. doi: 10.2165/00002018-200932010-00007.
Figueiras A, Herdeiro MT, Polonia J, Gestal-Otero JJ. An educational intervention to improve physician reporting of adverse drug reactions: a cluster-randomized controlled trial. JAMA. 2006 Sep 6;296(9):1086-93. doi: 10.1001/jama.296.9.1086.
Herdeiro MT, Ribeiro-Vaz I, Ferreira M, Polonia J, Falcao A, Figueiras A. Workshop- and telephone-based interventions to improve adverse drug reaction reporting: a cluster-randomized trial in Portugal. Drug Saf. 2012 Aug 1;35(8):655-65. doi: 10.1007/BF03261962.
Herdeiro MT, Polonia J, Gestal-Otero JJ, Figueiras A. Improving the reporting of adverse drug reactions: a cluster-randomized trial among pharmacists in Portugal. Drug Saf. 2008;31(4):335-44. doi: 10.2165/00002018-200831040-00007.
Ribeiro-Vaz I, Herdeiro MT, Polonia J, Figueiras A. Strategies to increase the sensitivity of pharmacovigilance in Portugal. Rev Saude Publica. 2011 Feb;45(1):129-35. doi: 10.1590/s0034-89102010005000050. Epub 2010 Nov 12. English, Portuguese.
Biagi C, Montanaro N, Buccellato E, Roberto G, Vaccheri A, Motola D. Underreporting in pharmacovigilance: an intervention for Italian GPs (Emilia-Romagna region). Eur J Clin Pharmacol. 2013 Feb;69(2):237-44. doi: 10.1007/s00228-012-1321-7. Epub 2012 Jun 17.
Other Identifiers
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E015/10
Identifier Type: -
Identifier Source: org_study_id
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