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

University Hospital of Bordeaux

Status: Completed

Conditions: Neonatal Intensive Care

Treatments: Behavioral: Education program for NICU caregivers.

Study type: Observational

Funder types: Other

Identifiers

NCT03036449

CHUBX 2014/38

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5,143 patients

Sex: All

Ages: Under 2 years old

Volunteers: No Healthy Volunteers

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.

Trial design

5,143 participants in 3 patient groups

A

Description:

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.

Treatment:

Behavioral: Education program for NICU caregivers.

B

Description:

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.

Treatment:

Behavioral: Education program for NICU caregivers.

C

Description:

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.

Treatment:

Behavioral: Education program for NICU caregivers.