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Clinical Trials/NCT03036449
NCT03036449
Completed
Not Applicable

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

University Hospital, Bordeaux3 sites in 1 country5,143 target enrollmentNovember 13, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neonatal Intensive Care
Sponsor
University Hospital, Bordeaux
Enrollment
5143
Locations
3
Primary Endpoint
Medication administration error rates in the patients
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 13, 2017
End Date
March 17, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Acceptance of the educational program(Baseline and up to 49 weeks)
  • Levels of medication errors reported by caregivers.(Baseline and up to 49 weeks)
  • Levels of safety culture among the caregivers (Nurses)(Baseline and up to 49 weeks)

Study Sites (3)

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