Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing

Not Applicable

Completed

• Conditions: Adverse Drug Event
• Interventions: Other: Pharmacovigilance Program

• Registration Number: NCT05402254
• Lead Sponsor: Natalia Rodriguez Galan

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2022-05-01
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-05-31
• Study First Posted: 2022-06-02
• Primary Completion: 2022-11-01
• Study Completion: 2022-12-30
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 395

Inclusion Criteria

1. Patients with pharmacological treatment.
2. Patients of both sexes aged between 0 and 100 years.
3. Patients admitted to medical or surgical hospitalization units or emergency services for at least 24 hours.
4. Patients who have received the information and agreed to participate in the study.

Exclusion Criteria

1. Patients included in other clinical trials or drug studies at the time of selection.
2. Patients with significant cognitive impairment, without adequate family support or primary caregiver.
3. Patients and/or caregivers who, once offered to participate in the study, do not give their consent
4. Impossibility of communication due to language barriers or other biopsychosocial problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmacovigilance Program	Pharmacovigilance Program	Intensive nursing intervention is carried out for the identification and notification of ADE

Primary Outcome Measures

Name	Time	Method
Adverse drug event	Seven months	Number of identified adverse drug event

Trial Locations

Locations (1)

Hospital San Carlos; 🇪🇸 Madrid, Spain