Clinical trial NCT02134587: Educational Intervention in Pharmacovigilance for Hospital Health Professionals
Official title: Implementation of a Hospital Pharmacovigilance Service and Comparison of Algorithms for Adverse Drug Reaction Causality Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adverse Drug Reaction
Keywords: Health knowledge, attitudes, practices.
Adverse drug reaction reporting systems.
Pharmacovigilance. Product Surveillance, Postmarketing.
Drug-related side effects and adverse reactions.
Lead sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

All health professionals (physicians, pharmacists, nurses, auxiliaries of nurses and pharmacists, as well as the multidisciplinary team - social assistants, physiotherapists, audiologists, nutritionists, psychologists, occupational therapists and administrative officers), with employment link at the hospital under study who agree to participate by signing an informed consent form are going to be enrolled.

Exclusion Criteria:

The exclusion criteria meet professionals who will be on sick leave, vacation, those who will not to be registered to carry out the intervention and those who will refuse to answer the questionnaire, despite to having shown interest in participating in the lecture and practical class.

Primary outcomes:
measure: Absolute Number of ADE Reporting (Change Behavior of Health Professionals)
timeFrame: 12 months
Secondary outcomes:
measure: Knowledge (Awareness) Regarding Pharmacovigilance
timeFrame: Two days
measure: Quality of ADE Reports
timeFrame: Two days
Other outcomes:
Locations:
city: Américo Brasiliense
country: Brazil
facility: Hospital Estadual Américo Brasiliense
state: São Paulo
Study officials:
affiliation: School of Pharmaceutical Sciences of Unesp
name: Patricia C Mastroianni, PhD
role: STUDY_CHAIR
affiliation: School of Pharmaceutical Sciences of Unesp
name: Fabiana R Varallo, Master
role: PRINCIPAL_INVESTIGATOR
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