NCT05402254

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
395

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

6 months

First QC Date

May 23, 2022

Last Update Submit

October 16, 2024

Conditions

Adverse Drug Event

Outcome Measures

Primary Outcomes (1)

  • Adverse drug event

    Number of identified adverse drug event

    Seven months

Study Arms (2)

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

Pharmacovigilance ProgramOTHER

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

Pharmacovigilance Program

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San Carlos

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Officials

  • Natalia Rodriguez Galán

    Hospital San Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 23, 2022

First Posted

June 2, 2022

Study Start

May 1, 2022

Primary Completion

November 1, 2022

Study Completion

December 30, 2022

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)