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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03036449
Acronym
OREANE
Enrollment
5143
Registered
2017-01-30
Start date
2017-11-13
Completion date
2019-03-17
Last updated
2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Intensive Care

Keywords

Medication errors, Patient safety

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.

Interventions

BEHAVIORALEducation 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…

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Medication administration error rates in the patientsBaseline and up to 49 weeksAssessment 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

MeasureTime frameDescription
Levels of safety culture among the caregivers (Nurses)Baseline and up to 49 weeksAssessment of the effectiveness of the educational intervention on increasing safety culture measured using Hospital Survey on patient safety.
Levels of medication errors reported by caregivers.Baseline and up to 49 weeksAssessment of the efficacy of the educational intervention to increase voluntary reporting of medication errors by caregivers.
Acceptance of the educational programBaseline and up to 49 weeksAssessment of acceptance by satisfaction questionnaire

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026