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

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

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).

Study Overview

• Status: Completed
• Conditions: Neonatal Intensive Care
• Intervention / Treatment: Behavioral: Education program for NICU caregivers.

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 5143

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Service de pédiatrie - Hôpital Pellegrin
  • Caen, France, 14033
    • CHU Côte de Nacre
  • Rouen, France, 76031
    • CHU de ROUEN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients less than 2 years old, hospitalized in the intensive care during the observation periods and receiving drugs.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
A; Group A: Phase 1: Observations (Baseline rate of errors); Phase 2: Main Educational program; Phase 3: Observations; Phase 4: Maintenance Educational program; Phase 5: Observations; Phase 6: Maintenance Educational program; Phase 7: Observations; Phase 8: Maintenance Educational program; Phase 9: Observations.	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…
B; Group B: Phase 1: Observations (Baseline rate of errors); Phase 2: No intervention; Phase 3: Observations (Baseline rate of errors); Phase 4: Main Educational program; Phase 5: Observations; Phase 6: Maintenance Educational program; Phase 7: Observations; Phase 8: Maintenance Educational program; Phase 9: Observations.	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…
C; Group C: Phase 1: Observations (Baseline rate of errors); Phase 2: No intervention; Phase 3: Observations (Baseline rate of errors); Phase 4: No intervention; Phase 5: Observations (Baseline rate of errors); Phase 6: Main educational program; Phase 7: Observations; Phase 8: Maintenance educational program; Phase 9: Observations.	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…

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Acceptance of the educational program	Assessment of acceptance by satisfaction questionnaire	Baseline and up to 49 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Actual): March 17, 2019
• Study Completion (Actual): March 17, 2019

Study Registration Dates

• First Submitted: December 23, 2016
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 12, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Patient safety; Medication errors
• Other Study ID Numbers: CHUBX 2014/38