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

Completed

• Conditions: Neonatal Intensive Care
• Interventions: Behavioral: Education program for NICU caregivers.

• Registration Number: NCT03036449
• Lead Sponsor: University Hospital, Bordeaux

Brief 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).

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 Timeline

• Study First Submitted: 2016-12-23
• Study First Submitted QC: 2017-01-26
• Study First Posted: 2017-01-30
• Study Start: 2017-11-13
• Primary Completion: 2019-03-17
• Study Completion: 2019-03-17
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-12
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5143

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
A	Education program for NICU caregivers.	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.
B	Education program for NICU caregivers.	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.
C	Education program for NICU caregivers.	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.

Primary Outcome Measures

Name	Time	Method
Medication administration error rates in the patients	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 Outcome Measures

Name	Time	Method
Acceptance of the educational program	Baseline and up to 49 weeks	Assessment of acceptance by satisfaction questionnaire
Levels of medication errors reported by caregivers.	Baseline and up to 49 weeks	Assessment of the efficacy of the educational intervention to increase voluntary reporting of medication errors by caregivers.
Levels of safety culture among the caregivers (Nurses)	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.

Trial Locations

Locations (3)

CHU de Rouen; 🇫🇷 Rouen, France

Service de pédiatrie - Hôpital Pellegrin; 🇫🇷 Bordeaux, France

CHU Côte de Nacre; 🇫🇷 Caen, France