Reducing Errors In The Neonatal Intensive Care Unit

NCT ID: NCT04193839

Last Updated: 2019-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-06-01

Brief Summary

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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

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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.

Conditions

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

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

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)

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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Lack of parental consent
Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Poliambulanza Istituto Ospedaliero

OTHER

Sponsor Role lead

Responsible Party

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Maria Pierro

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Pierro, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Poliambulanza Istituto Ospedaliero

Locations

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Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Site Status

Countries

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Italy

Central Contacts

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Maria Pierro, MD, PhD

Role: CONTACT

Phone: +39030351

Email: [email protected]

Elena Vailati

Role: CONTACT

Phone: +39030351

Email: [email protected]

Facility Contacts

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Maria Pierro, MD, PhD

Role: primary

Maria Elena Vailati

Role: backup

Other Identifiers

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NP 3751

Identifier Type: -

Identifier Source: org_study_id