Health Knowledge, Attitudes, PracticeSIM-SAMNCT05543655
Impact of Simulation-Based Training on the Safety of Medication Administration
A study testing high fidelity simulation in people with Health Knowledge, Attitudes, Practice and Nurse Training, run by University Hospital, Angers at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Health Knowledge, Attitudes, Practice, Nurse Training, Simulation
- What is being tested?
- high fidelity simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 28 Sep 2022to 5 Oct 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nurses from conventional medical and surgical departments participating in the training
- people agreeing to participate in the study
Who cannot join
- Person refusing the processing of their data
Trial locations and contacts
1 site in 1 country.
France1 site
Simulation center All'Sims; University Hospital of Angers
Angers, 49000
About this study
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.
- Being tested
- high fidelity simulation
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high fidelity simulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: high fidelity simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: three month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start28 Sep 2022
- Primary completion3 Mar 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health Knowledge, Attitudes, PracticeStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05543655
- Sponsor's protocol ID
- 49RC22_0241
- Acronym
- SIM-SAM
- Status last verified
- Mar 2025
- First submitted
- 5 Sep 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Simulation-Based Training on the Safety of Medication Administration
- ClinicalTrials.gov ID
- NCT05543655
- Acronym / sponsor ID
- SIM-SAM / 49RC22_0241
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 16 Sep 2022 (actual)
- 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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| simulated | Experimental | Other: high fidelity simulationThe '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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nurses from conventional medical and surgical departments participating in the training
- people agreeing to participate in the study
Key exclusion criteria (1 listed)
- Person refusing the processing of their data
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 |
|---|---|---|
| high fidelity simulationEach 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. | Other | simulated |
Primary outcome
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
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 17 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high fidelity simulation in people with Health Knowledge, Attitudes, Practice and Nurse Training, run by University Hospital, Angers at 1 site 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 2 inclusion and 1 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 17 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
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). 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 17 Mar 2025.