Skip to main content
OpenTrials
Completed

NCT Number: NCT03036449

Efficacy of a Multifaceted Intervention to Reduce Medication Administration Errors in Neonatal Intensive Care Units

The purpose of this study is to determine whether an educational program for caregivers associated with convenient tools is effective to reduce medication preparation and administration errors in the Neonatal Intensive Care Units (NICU).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neonatal Intensive Care

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de pédiatrie - Hôpital Pellegrin, Bordeaux, France

Loading trial locations.

About this study

Medication errors are frequent in neonatal intensive care units and consequences are more severe than in adults. Although errors happen in each step of medication management process, a large proportion of errors occur during medication preparation and administration.

This study will test the hypothesis that rates of medication errors during preparation and administration will be reduced by implementing an education program for NICU caregivers (Nurses) and providing convenient tools.

The trial has a stepped wedge design, in which the NICU's from three hospitals in France will be randomized (Group A, B and C) to the timing of implementation of the educational intervention.

According to the allocation (Group A, B or C), the education intervention will include a complete main program of nine weeks and one to three maintenance educational periods.

Medication administration errors rates will be measured before (baseline measurements) and after each educational interventions (main or maintenance interventions).

Errors will be identified by direct observations of nurse's acts by external observers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All nurses working in the intensive care units in the day time.

Exclusion criteria

  • Nurses working as a float or pool nurses.
  • Nurses working at night.

Treatment and study plan

Education program for NICU caregivers.

Behavioral

Intervention includes a main initial educational program, maintenance education programs and tools supply

  • Main educational program will include 9 hours of courses into NICU (1 hour each week) and @ learning modules validation.

Topics: Main causes of medication errors, How to analyse retrospectively medication errors, Strategies to reduce medication errors, How to improve communication between health professional; Task interruption; Standardisation of preparation…..

  • Maintenance education program will return on specific topics of main program and will be fitted to each NICU needs.
  • Examples of Tools: check lists, medication neonatal formulary, "Sound alike" and "Look alike" drug lists…

Primary outcomes

  1. Medication administration error rates in the patients

    Time frame: Baseline and up to 49 weeks

    Assessment of the efficacy of the intervention on reducing the rates of medication administration errors.

    Error rate: Number of identified errors/Number of observed acts of administration*100, measured by direct observation of nurse's acts by specifically trained external observers.

Secondary outcomes

  1. Levels of safety culture among the caregivers (Nurses)

    Time frame: Baseline and up to 49 weeks

    Assessment of the effectiveness of the educational intervention on increasing safety culture measured using Hospital Survey on patient safety.

  2. Levels of medication errors reported by caregivers.

    Time frame: Baseline and up to 49 weeks

    Assessment of the efficacy of the educational intervention to increase voluntary reporting of medication errors by caregivers.

  3. Acceptance of the educational program

    Time frame: Baseline and up to 49 weeks

    Assessment of acceptance by satisfaction questionnaire

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

Efficacy of Tools Associated With a Multifaceted Education Intervention Directed to Health Professionals to Reduce Medication Preparation and Administration Error Rates in Neonatal Intensive Care Units

Acronym: OREANE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 30, 2017
Registry last updated
May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.