Impact of a Pharmacovigilance Program Led by Advanced Pra... | NCT05402254

Studies
Impact of a Pharmacovigilance Program Led by Advanced Practice Nursing

NCT05402254

Sponsor

Natalia Rodriguez Galan

Status

Completed

Last Update Posted

Oct 18, 2024Actual

Enrollment

395Actual

Phase

Not Applicable

Conditions

Adverse Drug Event

Interventions

Pharmacovigilance Program

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2022Actual

Primary Completion Date

Nov 1, 2022Actual

Completion Date

Dec 30, 2022Actual

First Submitted Date

May 23, 2022

First Submission Date that Met QC Criteria

May 31, 2022

First Posted Date

Jun 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 16, 2024

Last Update Posted Date

Oct 18, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Natalia Rodriguez Galan, principal investigator, Hospital San Carlos, MadridSponsor-Investigator

Lead Sponsor

Natalia Rodriguez GalanOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

395Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pharmacovigilance Program	Experimental	Intensive nursing intervention is carried out for the identification and notification of ADE	Other: Pharmacovigilance Program
Control	No Intervention	The Usual practice of the nursing care process

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pharmacovigilance Program	Other	Knowledge of the risks in the use of the drug, identification and notification of ADE	Pharmacovigilance Program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse drug event	Number of identified adverse drug event	Seven months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Natalia Rodriguez Galán	Hospital San Carlos	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital San Carlos		Madrid		28040	Spain

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders

Browse Leaves

Not provided

Browse Branches

Not provided