Neonatal Intensive CareOREANENCT03036449
Efficacy of a Multifaceted Intervention to Reduce Medication Administration Errors in Neonatal Intensive Care Units
An observational study of Neonatal Intensive Care, run by University Hospital, Bordeaux at 3 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Neonatal Intensive Care
- What is being tested?
- Education program for NICU caregivers.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 5,143 participants
- Where
- 3 sitesFrance
- Study dates
- 13 Nov 2017to 17 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients less than 2 years old, hospitalized in the intensive care during the observation periods and receiving drugs.
Who may be able to join
- All nurses working in the intensive care units in the day time.
Who cannot join
- Nurses working as a float or pool nurses.
- Nurses working at night.
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service de pédiatrie - Hôpital Pellegrin
Bordeaux, 33000
CHU Côte de Nacre
Caen, 14033
CHU de Rouen
Rouen, 76031
About this study
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
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).
Read the 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.
- Conditions
- Neonatal Intensive Care
- Being tested
- Education program for NICU caregivers.
- Keywords
- Medication errors, Patient safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education program for NICU caregivers.Behavioural
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…
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Education program for NICU caregivers. | |
| 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. Receives: Behavioral: Education program for NICU caregivers. | |
| 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. Receives: Behavioral: Education program for NICU caregivers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and up to 49 weeks
Secondary outcomes (3)
Levels of safety culture among the caregivers (Nurses)
Assessment of the effectiveness of the educational intervention on increasing safety culture measured using Hospital Survey on patient safety.
Measured: Baseline and up to 49 weeks
Levels of medication errors reported by caregivers.
Assessment of the efficacy of the educational intervention to increase voluntary reporting of medication errors by caregivers.
Measured: Baseline and up to 49 weeks
Acceptance of the educational program
Assessment of acceptance by satisfaction questionnaire
Measured: Baseline and up to 49 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start13 Nov 2017
- Primary completion17 Mar 2019
- Study completion17 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Intensive CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03036449
- Sponsor's protocol ID
- CHUBX 2014/38
- Acronym
- OREANE
- Status last verified
- May 2020
- First submitted
- 23 Dec 2016
- Last updated
- 13 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03036449
- Acronym / sponsor ID
- OREANE / CHUBX 2014/38
- Conditions
- Neonatal Intensive Care
- Keywords
- Medication errors, Patient safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,143 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 17 Mar 2019 (actual)
- Study completion
- 17 Mar 2019 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | – | Behavioral: Education program for NICU caregivers.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 | – | Behavioral: Education program for NICU caregivers.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 | – | Behavioral: Education program for NICU caregivers.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. |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients less than 2 years old, hospitalized in the intensive care during the observation periods and receiving drugs.
Key inclusion criteria (1 listed)
- All nurses working in the intensive care units in the day time.
Key exclusion criteria (2 listed)
- Nurses working as a float or pool nurses.
- Nurses working at night.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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… | Behavioural | A, B, C |
Primary outcome
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.
3 secondary outcomes
Levels of safety culture among the caregivers (Nurses)
Time frame: Baseline and up to 49 weeks
Levels of medication errors reported by caregivers.
Time frame: Baseline and up to 49 weeks
Acceptance of the educational program
Time frame: Baseline and up to 49 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Intensive Care, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medication administration error rates in the patients (time frame: Baseline and up to 49 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2020.