Reducing Errors In The Neonatal Intensive Care Unit

Adverse Drug Event Clinical Trial

— SAPHET-i  

Official title:

Reducing Errors In The Neonatal Intensive Care Unit. The SAPHET-i Study: Secure, Automated, Functional, High-Tech Therapeutic Approach for iNFANTS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04193839
• Other study ID #: NP 3751
• Status: Not yet recruiting
• Start date: January 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2019
• Source: Fondazione Poliambulanza Istituto Ospedaliero
• Contact: Maria Pierro, MD, PhD
• Phone: +39030351
• Email: maria.pierro[@]poliambulanza.it
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a monocentric prospective pre and post-intervention study, aiming at analyzing the efficacy of the Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) as compared to paper order entry in reducing medication erros (MEs) in the Neonatal Intensive Care Unit (NICU)

Description:

Medication errors are a burden to the health care system. The neonatal population, in particular the infants admitted to the NICU, are at higher risk of MEs as compared to the adult and pediatric population. Moreover adverse events (ADEs) occur more frequently and may be particularly severe in neonates.

Several strategies have been tried in order to decrease the incidence of MEs in the NICU. Among these, some studies investigated the effectiveness of CPOE in reducing MEs in hospitalised patients. However, results have been inconsistent. So far, no study investigated the association of CPOE + BCMA in neonates.

The investigators designed a monocentric prospective pre and post-intervention observational study to investigate the efficacy of the CPOE plus BCMA as compared to paper order entry in reducing MEs in the NICU population.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion criteria:

• Admission to the NICU

• Need of pharmacological intervention

• Informed parental consent

Exclusion criteria:

• Lack of parental consent

Related Conditions & MeSH terms

• Adverse Drug Event
• Drug-Related Side Effects and Adverse Reactions
• Medication Errors and Other Product Use Errors and Issues

Intervention

Other:
• Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA)
Computerized provider order entry (CPOE) refers to the process of providers entering and sending treatment instructions - including medication, laboratory, and radiology orders - via a computer application rather than paper, fax, or telephone. The bar Code Medication Administration (BCMA) is a system that consists of a bar code reader, a portable or desktop computer with wireless connection, a computer server, and some software. Before the administration of medications to the patients the patient unique barcode identification is scanned in order to verify the patient's identity.

Locations

Country	Name	City	State
Italy	Fondazione Poliambulanza Istituto Ospedaliero	Brescia

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Poliambulanza Istituto Ospedaliero

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of medication errors	The investigators will record all types of errors (prescription, transcription, preparation, administration errors) through spontaneous reporting, structured daily audit and chart revision	From date of NICU admission up to discharge, up to 18 months
Secondary	Number of preventable adverse drug events	The investigators will record the number of preventable and non preventable adverse drug events	From date of NICU admission up to discharge, up to 18 months