Implementation of a Hospital Pharmacovigilance Service and Comparison of Algorithms for Adverse Drug Reaction Causality Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- Absolute Number of ADE Reporting (Change Behavior of Health Professionals)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Subjects post educational intervention
Multifaceted educational intervention in pharmacovigilance
干预措施: Multifaceted educational intervention (Other)
结局指标
主要结局
Absolute Number of ADE Reporting (Change Behavior of Health Professionals)
时间窗: 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.
次要结局
- Quality of ADE Reports(Two days)
- Knowledge (Awareness) Regarding Pharmacovigilance(Two days)
研究者
Fabiana Rossi Varallo
Clinical pharmacist and PhD student
Universidade Estadual Paulista Júlio de Mesquita Filho