Reducing Errors In The Neonatal Intensive Care Unit

• Conditions: Medication Errors and Other Product Use Errors and Issues; Adverse Drug Event

• Registration Number: NCT04193839
• Lead Sponsor: Fondazione Poliambulanza Istituto Ospedaliero

Brief 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)

Detailed 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.

Study Timeline

• Study First Submitted: 2019-11-28
• Status Verified: 2019-12
• Study First Submitted QC: 2019-12-09
• Last Update Submitted: 2019-12-09
• Study First Posted: 2019-12-10
• Last Update Posted: 2019-12-10
• Study Start: 2020-01-01
• Primary Completion: 2021-05-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of medication errors	From date of NICU admission up to discharge, up to 18 months	The investigators will record all types of errors (prescription, transcription, preparation, administration errors) through spontaneous reporting, structured daily audit and chart revision

Secondary Outcome Measures

Name	Time	Method
Number of preventable adverse drug events	From date of NICU admission up to discharge, up to 18 months	The investigators will record the number of preventable and non preventable adverse drug events

Trial Locations

Locations (1)

Fondazione Poliambulanza Istituto Ospedaliero; 🇮🇹 Brescia, Italy