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

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ClinicalTrials.gov Identifier: NCT03036449
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : July 31, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Neonatal Intensive Care Behavioral: Education program for NICU caregivers.

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.


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Study Type : Observational
Actual Enrollment : 5143 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : November 13, 2017
Actual Primary Completion Date : March 17, 2019
Actual Study Completion Date : March 17, 2019

Resource links provided by the National Library of Medicine


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.
Behavioral: Education 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…

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.
Behavioral: Education 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…

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.
Behavioral: Education 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…




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. Acceptance of the educational program [ Time Frame: Baseline and up to 49 weeks ]
    Assessment of acceptance by satisfaction questionnaire



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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients less than 2 years old, hospitalized in the intensive care during the observation periods and receiving drugs.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036449


Locations
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France
Service de pédiatrie - Hôpital Pellegrin
Bordeaux, France, 33000
CHU Côte de Nacre
Caen, France, 14033
CHU de Rouen
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Bordeaux

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03036449     History of Changes
Other Study ID Numbers: CHUBX 2014/38
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019

Keywords provided by University Hospital, Bordeaux:
Medication errors
Patient safety