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

Neonatal Intensive Care Clinical Trial

— OREANE  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03036449
• Other study ID #: CHUBX 2014/38
• Status: Completed
• Start date: November 13, 2017
• Est. completion date: March 17, 2019

Study information

• Verified date: May 2020
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5143
• Est. completion date: March 17, 2019
• Est. primary completion date: March 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neonatal Intensive Care

Intervention

Behavioral:
• Education program for NICU caregivers.
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…

Locations

Country	Name	City	State
France	Service de pédiatrie - Hôpital Pellegrin	Bordeaux
France	CHU Côte de Nacre	Caen
France	CHU de Rouen	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication administration error rates in the patients	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.	Baseline and up to 49 weeks
Secondary	Levels of safety culture among the caregivers (Nurses)	Assessment of the effectiveness of the educational intervention on increasing safety culture measured using Hospital Survey on patient safety.	Baseline and up to 49 weeks
Secondary	Levels of medication errors reported by caregivers.	Assessment of the efficacy of the educational intervention to increase voluntary reporting of medication errors by caregivers.	Baseline and up to 49 weeks
Secondary	Acceptance of the educational program	Assessment of acceptance by satisfaction questionnaire	Baseline and up to 49 weeks