Impact of Simulation-Based Training on the Safety of Medication Administration (SIM-SAM)

March 14, 2025 updated by: University Hospital, Angers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49000
        • Simulation center All'Sims; University Hospital of Angers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Person refusing the processing of their data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: simulated
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: three month
Difference between the two assessments of the number of good steps performed during the process
three month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Angers

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2022

Primary Completion (Actual)

March 3, 2023

Study Completion (Actual)

October 5, 2023

Study Registration Dates

First Submitted

September 5, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 49RC22_0241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Simulation

Clinical Trials on high fidelity simulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Trinidad & Tobago

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe