Educational Intervention in Pharmacovigilance for Hospital Health Professionals (EIPhv)
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|ClinicalTrials.gov Identifier: NCT02134587|
Recruitment Status : Completed
First Posted : May 9, 2014
Results First Posted : August 20, 2015
Last Update Posted : August 20, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Adverse Drug Reaction||Other: Multifaceted educational intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implementation of a Hospital Pharmacovigilance Service and Comparison of Algorithms for Adverse Drug Reaction Causality Assessment|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||May 2014|
Subjects post educational intervention
Multifaceted educational intervention in pharmacovigilance
Other: Multifaceted educational intervention
- Absolute Number of ADE Reporting (Change Behavior of Health Professionals) [ Time Frame: 12 months ]Investigators are going to verify the numbers of adverse drug events reported by health professionals which was made 12 months before educational intervention. A follow up across 12 months post-educational intervention also will be performed, in order to identify the number of adverse drug events reported by health professionals. Prevalence of ADE in both periods will be estimated and compared, in order to asses the impact of the intervention on change behavior of health professionals.
- Knowledge (Awareness) Regarding Pharmacovigilance [ Time Frame: Two days ]Knowledge assessment will be performed by content analysis of answers obtained from questionnaire, being assigned scores from zero to ten. Definitions related to pharmacovigilance of World Health Organization will be considered gold-standard answers. Scores below five will be classified as unsatisfactory, among five and 7.5 were considered regular and above 7.6 satisfactory on the knowledge acquisition.The questionnaire will be applied in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings. Data will be compared, in order to assess the impact of educational intervention on knowledge of health professionals.
- Quality of ADE Reports [ Time Frame: Two days ]Skills evaluation will be carried out according to the perception of the voluntary regarding the relevance´s degree of the information to be filled in ADE form. Therefore, in the first (prior to educational intervention) and fourth (post-educational intervention period) meetings, subjects will be asked to highlight the fields of ADE form, according to unnecessary, necessary or essential information to be reported. Minimal and desirable criteria to be filled in ADE form preconized by Pan-American Health Organization will be considered gold-standard answers. Scores from zero to ten will be assigned, according to gold-standard answers. Data will be compared, in order to estimate the impact of educational intervention on skills to fill ADE form.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134587
|Hospital Estadual Américo Brasiliense|
|Américo Brasiliense, São Paulo, Brazil, 14820-000|
|Study Chair:||Patricia C Mastroianni, PhD||School of Pharmaceutical Sciences of Unesp|
|Principal Investigator:||Fabiana R Varallo, Master||School of Pharmaceutical Sciences of Unesp|