IMPACTO: Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing

• Sponsor: Hospital San Carlos, Madrid (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05402254
• Collaborator: (none)
• Enrollment: 394
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 20
• Patients Per Site Per Month: 19.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adverse Drug Event	Other: Pharmacovigilance Program	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 394 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of the Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing on Patients and Professionals at Hospital: Intervention Study
• Actual Study Start Date: May 1, 2022
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pharmacovigilance Program Intensive nursing intervention is carried out for the identification and notification of ADE	Other: Pharmacovigilance Program; Knowledge of the risks in the use of the drug, identification and notification of ADE
No Intervention: Control The Usual practice of the nursing care process

Outcome Measures

Primary Outcome Measures

1. Adverse drug event [Seven months]

   Number of identified adverse drug event

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital San Carlos	Madrid		Spain	28040

Sponsors and Collaborators

• Hospital San Carlos, Madrid

Investigators

• Principal Investigator: Natalia Rodriguez Galán, Hospital San Carlos

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Natalia Rodriguez Galan, Principal Investigator, Hospital San Carlos, Madrid
• ClinicalTrials.gov Identifier: NCT05402254
• Other Study ID Numbers: EI-FC-2022-03
• First Posted: Jun 2, 2022
• Last Update Posted: Aug 3, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Drug-Related Side Effects and Adverse Reactions

Study Results

No Results Posted as of Aug 3, 2022