Safer Use of Medication in Pediatric Patients at Home

Safer Use of Medication in Pediatric Patients at Home: Error Reporting Website

This study aims:

• to develop a web-based notification system for caregivers of pediatric patients that allows to report medication errors and, based on this notification, and to share experiences and alerts about common errors of patients.
• to assess de user satisfaction and perceived usefulness of the system.

Participants:

Parents with children who have required drug treatment in the last two months, who have an Internet connection and who agree to participate in the study.

Sample size: 62 participants

Main outcome variable: overall satisfaction

Study Overview

• Status: Enrolling by invitation
• Conditions: Medication Errors and Other Product Use Errors and Issues
• Intervention / Treatment: Other: Study group

• Study Type: Observational
• Enrollment (Anticipated): 62

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Elche, Alicante, Spain, 03202
      • Mercedes Gilabert

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Parents or caregivers of children aged from 0 to 14 years.

Description

Inclusion Criteria:

• To care children aged under 14 years who have required drug treatment in the last two months
• To have an Internet connection
• To agree to participate in the study.
• To be registered in the study web-based notification system
• Age > 17 years

Exclusion Criteria:

• To be health provider
• To care children in residence for minors.
• To care children with a life expectancy of less than 2 years.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group	Other: Study group; The study group uses a web-based medication error notification system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with the web-based medication error notification system	Overall satisfaction with the web-based medication error notification system by an ad hoc questionnaire	At one month after use of the website

Collaborators and Investigators

• Sponsor: Universidad Miguel Hernandez de Elche

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 15, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PI18/00739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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