Adverse Drug Event Clinical Trial
Official title:
Evaluation of the Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing on Patients and Professionals at Hospital: Intervention Study
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.
PRIMARY OBJETIVES 1. To assess whether an advanced nursing intervention improves the identification and reporting of suspected ADR. SECONDARY OBJECTIVES 1. To determine if an advanced nursing intervention improves the experience related to the use of medications measured through the QExPac-21 patient experience questionnaire. 2. Identify which factors associated with medications increase the risk of ADRs and the characteristics of the patients. 3. Know the incidence and describe ADRs: severity, preventability, and causality using validated scales. 4. 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. 5. Quantify the number of interconsultation generated by patients and professionals related to the use of drugs. 6. 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. ;
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