NCT05543655

Brief Summary

Task interruption is part of professional life. The healthcare world is not exempt from this phenomenon. Task interruptions lead to errors and increase the risks in managing patients. Medication administration is the critical step, in that it is the final step to stop medication errors produced upstream. It therefore requires the full attention of any healthcare professional. In the field of health, simulation has become an innovative educational tool allowing experiential learning and reflective practice. The general aim of this study is to objectivize the value of simulation-based training as regards medication administration when task interruptions occur.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

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

September 5, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 16, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

September 28, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2023

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

September 5, 2022

Last Update Submit

March 14, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The effectiveness of simulation-based training on safe drug administration for nurses in conventional services in terms of the number of good steps achieved among the 10 proposed by the HAS

    Difference between the two assessments of the number of good steps performed during the process

    three month

Study Arms (1)

simulated

EXPERIMENTAL

The 'Simulation training', using high fidelity simulation with a simulated patient, is composed of 2 training sessions of 3 hours each. The training will include a high-fidelity scenario whose events will be adapted to medication administration in conventional care services. This scenario is developed by a multidisciplinary team of healthcare professionals, experts in simulation and risk management

Other: high fidelity simulation

Interventions

Each half-day training session will begin with a reminder of the context and general objectives of the training. Nurses will complete the self-assessment and knowledge tests. The nurses, each in turn, will start the scenario and will immediately assess the workload felt, by the Nasa-TLX grid. During these high-fidelity simulation sessions, an "error cart" workshop will allow all the other nurses to summon up their knowledge on safety tools upstream of the administration procedure. The session begins with a briefing and ends with a debriefing.

simulated

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Nurses from conventional medical and surgical departments participating in the training
  • people agreeing to participate in the study

You may not qualify if:

  • Person refusing the processing of their data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simulation center All'Sims; University Hospital of Angers

Angers, 49000, France

Location

MeSH Terms

Conditions

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 10 training courses including 4 nurses each are scheduled, i.e. 40 inclusions. The nurses will benefit from two half-days of simulation training three-months apart, dealing with the safety of medication administration. The training will include a high-fidelity scenario whose events will be adapted to medication administration in conventional care services.
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2022

First Posted

September 16, 2022

Study Start

September 28, 2022

Primary Completion

March 3, 2023

Study Completion

October 5, 2023

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations