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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
Sponsor:
Information provided by (Responsible Party):
Fabiana Rossi Varallo, Universidade Estadual Paulista Júlio de Mesquita Filho

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.


Condition or disease Intervention/treatment Phase
Adverse Drug Reaction Other: Multifaceted educational intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Subjects post educational intervention
Multifaceted educational intervention in pharmacovigilance
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

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


Locations
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Brazil
Hospital Estadual Américo Brasiliense
Américo Brasiliense, São Paulo, Brazil, 14820-000
Sponsors and Collaborators
Universidade Estadual Paulista Júlio de Mesquita Filho
Investigators
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Study Chair: Patricia C Mastroianni, PhD School of Pharmaceutical Sciences of Unesp
Principal Investigator: Fabiana R Varallo, Master School of Pharmaceutical Sciences of Unesp
Publications:

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Responsible Party: Fabiana Rossi Varallo, Clinical pharmacist and PhD student, Universidade Estadual Paulista Júlio de Mesquita Filho
ClinicalTrials.gov Identifier: NCT02134587    
Other Study ID Numbers: E015/10
First Posted: May 9, 2014    Key Record Dates
Results First Posted: August 20, 2015
Last Update Posted: August 20, 2015
Last Verified: July 2015
Keywords provided by Fabiana Rossi Varallo, Universidade Estadual Paulista Júlio de Mesquita Filho:
Health knowledge, attitudes, practices.
Adverse drug reaction reporting systems.
Pharmacovigilance. Product Surveillance, Postmarketing.
Drug-related side effects and adverse reactions.
Additional relevant MeSH terms:
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Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders