Reducing Errors In The Neonatal Intensive Care Unit

Overview

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)

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

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 1, 2021

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.

Interventions

  • 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.

Arms, Groups and Cohorts

  • Paper Order Entry cohort
    • Patients admitted to the NICU during the pre-intervention phase, enrolled in the study after parental consent. The medications prescribed to the patients enrolled during the pre-intervention period will be handled with the paper order entry
  • CPOE + BCMA cohort
    • Patients admitted to the NICU during the post-intervention phase, enrolled in the study after parental consent. The medications prescribed to the patients enrolled during the post-intervention period will be handled with the Computerized Provider Order Entry + Bar Code Medication Administration (BCMA)

Clinical Trial Outcome Measures

Primary Measures

  • Number of medication errors
    • Time Frame: 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 Measures

  • Number of preventable adverse drug events
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

  • Admission to the NICU
  • Need of pharmacological intervention
  • Informed parental consent

Exclusion Criteria

  • Lack of parental consent

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 6 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione Poliambulanza Istituto Ospedaliero
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maria Pierro, Principal investigator – Fondazione Poliambulanza Istituto Ospedaliero
  • Overall Official(s)
    • Maria Pierro, MD, PhD, Principal Investigator, Fondazione Poliambulanza Istituto Ospedaliero
  • Overall Contact(s)
    • Maria Pierro, MD, PhD, +39030351, maria.pierro@poliambulanza.it

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