Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing

Adverse Drug Event Clinical Trial

— IMPACTO  

Official title:

Evaluation of the Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing on Patients and Professionals at Hospital: Intervention Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05402254
• Other study ID #: EI-FC-2022-03
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2022
• Source: Hospital San Carlos, Madrid
• Contact: Natalia Rodriguez
• Phone: 627551464
• Email: nrgalan[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 394
• Est. completion date: December 30, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug-Related Side Effects and Adverse Reactions

Intervention

Other:
• Pharmacovigilance Program
Knowledge of the risks in the use of the drug, identification and notification of ADE

Locations

Country	Name	City	State
Spain	Hospital San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Hospital San Carlos, Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse drug event	Number of identified adverse drug event	Seven months