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
1 other identifier
observational
5,143
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2017
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2016
CompletedFirst Posted
Study publicly available on registry
January 30, 2017
CompletedStudy Start
First participant enrolled
November 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2019
CompletedMay 13, 2020
May 1, 2020
1.3 years
December 23, 2016
May 12, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Levels of safety culture among the caregivers (Nurses)
Baseline and up to 49 weeks
Levels of medication errors reported by caregivers.
Baseline and up to 49 weeks
Acceptance of the educational program
Baseline and up to 49 weeks
Study Arms (3)
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.
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.
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.
Interventions
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…
Eligibility Criteria
Patients less than 2 years old, hospitalized in the intensive care during the observation periods and receiving drugs.
You may qualify if:
- All nurses working in the intensive care units in the day time.
You may not qualify if:
- Nurses working as a float or pool nurses.
- Nurses working at night.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Service de pédiatrie - Hôpital Pellegrin
Bordeaux, 33000, France
CHU Côte de Nacre
Caen, 14033, France
CHU de Rouen
Rouen, 76031, France
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2016
First Posted
January 30, 2017
Study Start
November 13, 2017
Primary Completion
March 17, 2019
Study Completion
March 17, 2019
Last Updated
May 13, 2020
Record last verified: 2020-05