Evaluation of the Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing on Patients and Professionals at Hospital: Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 395
- 试验地点
- 1
- 主要终点
- Adverse drug event
研究概览
简要总结
HYPOTHESIS An advanced practice nursing intervention in the area of pharmacovigilance performed on patients and professionals improves the identification and reporting of suspected adverse drug reactions (ADR) and improves the overall experience of hospitalized patients.
详细描述
PRIMARY OBJETIVES
- To assess whether an advanced nursing intervention improves the identification and reporting of suspected ADR.
SECONDARY OBJECTIVES
- To determine if an advanced nursing intervention improves the experience related to the use of medications measured through the QExPac-21 patient experience questionnaire.
- Identify which factors associated with medications increase the risk of ADRs and the characteristics of the patients.
- Know the incidence and describe ADRs: severity, preventability, and causality using validated scales.
- Describe the degree of nursing intervention according to the North American Nursing Diagnosis Association (NANDA) Taxonomy, and the classification of nursing interventions (NIC) Related to drug use.
- Quantify the number of interconsultation generated by patients and professionals related to the use of drugs.
- Determine the degree of adherence and compliance with the regimens prescribed to the patients.
STUDY DESIGN Prospective, randomized and controlled study of an intervention that compares a group of patients according to the usual practice of the nursing care process, against another on which a more intensive nursing intervention is carried out for the identification and notification of ADRs. It is carried out on a representative sample of patients admitted to a tertiary level hospital with 860 beds of the Madrid Health Service during the year 2022.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with pharmacological treatment.
- •Patients of both sexes aged between 0 and 100 years.
- •Patients admitted to medical or surgical hospitalization units or emergency services for at least 24 hours.
- •Patients who have received the information and agreed to participate in the study.
排除标准
- •Patients included in other clinical trials or drug studies at the time of selection.
- •Patients with significant cognitive impairment, without adequate family support or primary caregiver.
- •Patients and/or caregivers who, once offered to participate in the study, do not give their consent
- •Impossibility of communication due to language barriers or other biopsychosocial problems.
研究组 & 干预措施
Pharmacovigilance Program
Intensive nursing intervention is carried out for the identification and notification of ADE
干预措施: Pharmacovigilance Program (Other)
Control
The Usual practice of the nursing care process
结局指标
主要结局
Adverse drug event
时间窗: Seven months
Number of identified adverse drug event
次要结局
未报告次要终点
研究者
Natalia Rodriguez Galan
principal investigator
Hospital San Carlos, Madrid