Reducing Errors In The Neonatal Intensive Care Unit

NCT04193839 | Unknown

• 1 other identifier: NP 3751
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Medication Errors and Other Product Use Errors and Issues; Adverse Drug Event

Keywords

Computerized Provider Order entry; Patient safety; Quality improvement; Medication errors; Adverse events; Bar code medication administration; Neonates

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of preventable adverse drug events

  From date of NICU admission up to discharge, up to 18 months

Study Arms (2)

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)

Other: Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA)

Interventions

Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA) OTHER

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.

CPOE + BCMA cohort

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Any patient admitted to the NICU who needs pharmacological intervention is eligible.

You may qualify if:

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

You may not qualify if:

• Lack of parental consent

Sponsors & Collaborators

• Fondazione Poliambulanza Istituto Ospedaliero: lead

Study Sites (1)

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Location

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Medical Order Entry Systems

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Hospital Information Systems; Hospital Administration; Health Facility Administration; Organization and Administration; Health Services Administration; Management Information Systems; Medical Records Systems, Computerized; Medical Records; Records

Study Officials

• Maria Pierro, MD, PhD

  Fondazione Poliambulanza Istituto Ospedaliero

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Pierro, MD, PhD

CONTACT

+39030351; maria.pierro@poliambulanza.it

Elena Vailati

CONTACT

+39030351; elena.vailati@poliambulanza.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 28, 2019
• First Posted: December 10, 2019
• Study Start: January 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: June 1, 2021
• Last Updated: December 10, 2019

Record last verified: 2019-12

Locations

IT (1)