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

Sponsor

University Hospital, Angers (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05543655

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Health Knowledge, Attitudes, Practice Nurse Training Simulation	Other: high fidelity simulation	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

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.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.

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Impact of Simulation-Based Training on the Safety of Medication Administration

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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 [three month]
Difference between the two assessments of the number of good steps performed during the process

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Simulation center All'Sims; University Hospital of Angers	Angers		France	49000

Sponsors and Collaborators

University Hospital, Angers

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Angers

ClinicalTrials.gov Identifier:

NCT05543655

Other Study ID Numbers:

49RC22_0241

First Posted:

Sep 16, 2022

Last Update Posted:

Sep 16, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Sep 16, 2022