- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03036449
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Bordeaux, France, 33000
- Service de pédiatrie - Hôpital Pellegrin
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Caen, France, 14033
- CHU côte de Nacre
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Rouen, France, 76031
- CHU de Rouen
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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.
|
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…..
|
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.
|
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…..
|
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.
|
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…..
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Baseline and up to 49 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Levels of safety culture among the caregivers (Nurses)
Time Frame: 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.
|
Baseline and up to 49 weeks
|
Levels of medication errors reported by caregivers.
Time Frame: Baseline and up to 49 weeks
|
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
Time Frame: Baseline and up to 49 weeks
|
Assessment of acceptance by satisfaction questionnaire
|
Baseline and up to 49 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHUBX 2014/38
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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