Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

395 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2022-12-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Adverse Drug Event

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Pharmacovigilance Program

Intensive nursing intervention is carried out for the identification and notification of ADE

Group Type EXPERIMENTAL

Pharmacovigilance Program

Intervention Type OTHER

Knowledge of the risks in the use of the drug, identification and notification of ADE

Control

The Usual practice of the nursing care process

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Pharmacovigilance Program

Knowledge of the risks in the use of the drug, identification and notification of ADE

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes