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Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing (IMPACTO)

Primary Purpose

Adverse Drug Event

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pharmacovigilance Program
Sponsored by
Hospital San Carlos, Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adverse Drug Event

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Hospital San CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pharmacovigilance Program

Control

Arm Description

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

The Usual practice of the nursing care process

Outcomes

Primary Outcome Measures

Adverse drug event
Number of identified adverse drug event

Secondary Outcome Measures

Full Information

First Posted
May 23, 2022
Last Updated
August 2, 2022
Sponsor
Hospital San Carlos, Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT05402254
Brief Title
Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing
Acronym
IMPACTO
Official Title
Evaluation of the Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing on Patients and Professionals at Hospital: Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid

4. Oversight

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
Data Monitoring Committee
No

5. 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.
Detailed Description
PRIMARY OBJETIVES 1. To assess whether an advanced nursing intervention improves the identification and reporting of suspected ADR. SECONDARY OBJECTIVES To determine if an advanced nursing intervention improves the experience related to the use of medications measured through the QExPac-21 patient experience questionnaire. Identify which factors associated with medications increase the risk of ADRs and the characteristics of the patients. Know the incidence and describe ADRs: severity, preventability, and causality using validated scales. 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. Quantify the number of interconsultation generated by patients and professionals related to the use of drugs. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adverse Drug Event

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
394 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pharmacovigilance Program
Arm Type
Experimental
Arm Description
Intensive nursing intervention is carried out for the identification and notification of ADE
Arm Title
Control
Arm Type
No Intervention
Arm Description
The Usual practice of the nursing care process
Intervention Type
Other
Intervention Name(s)
Pharmacovigilance Program
Intervention Description
Knowledge of the risks in the use of the drug, identification and notification of ADE
Primary Outcome Measure Information:
Title
Adverse drug event
Description
Number of identified adverse drug event
Time Frame
Seven months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with pharmacological treatment. Patients of both sexes aged between 0 and 100 years. Patients admitted to medical or surgical hospitalization units or emergency services for at least 24 hours. Patients who have received the information and agreed to participate in the study. Exclusion Criteria: Patients included in other clinical trials or drug studies at the time of selection. Patients with significant cognitive impairment, without adequate family support or primary caregiver. Patients and/or caregivers who, once offered to participate in the study, do not give their consent Impossibility of communication due to language barriers or other biopsychosocial problems.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia Rodriguez
Phone
627551464
Email
nrgalan@salud.madrid.org
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Belen Rivas
Phone
627551464
Email
anabelen.rivas@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalia Rodriguez Galán
Organizational Affiliation
Hospital San Carlos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia Rodriguez
Phone
913303000
Ext
3413
Email
nrgalan@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Ana Rivas
Phone
913303000
Ext
3413
Email
anabelen.rivas@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Natalia Rodríguez Galán

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing

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