Medical Education, Simulation, Crisis Resource ManagementInfecSIMNCT07381270
Using Simulation-based Team Training to Improve Psychological Safety and Relational Coordination as Well as Conducting a Process Evaluation
A study testing Simulation-based team training in people with Medical Education, Simulation, Crisis Resource Management and Simulation Training, run by University of Aarhus at 1 site in Denmark.
Trial summary
Simulation-based team training is increasingly used in hospitals to support teamwork and communication, particularly in situations that are complex or time-critical. While such training is known to improve observable team behaviours, less is known about how it is implemented in everyday clinical work and how it… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Education, Simulation, Crisis Resource Management, Simulation Training, Simulation Based Medical Education
- What is being tested?
- Simulation-based team training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2025to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Employed in the included departments
- Profession as a doctor or nurse
Who cannot join
- If participants are employed in both intervention and control group during the project period
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Infectious Diseases, Aarhus University Hospital
Aarhus, 8200
About this study
Official title: Simulation-Based Team Training to Improve Psychological Safety and Relational Coordination in Clinical Teams
Simulation-based team training is increasingly used in hospitals to support teamwork and communication, particularly in situations that are complex or time-critical. While such training is known to improve observable team behaviours, less is known about how it is implemented in everyday clinical work and how it influences relational aspects of teamwork, such as psychological safety and relational coordination.
This study explores the implementation and perceived impact of a simulation-based training programme focused on infectious disease management in a hospital department. Psychological safety refers to whether staff feel safe to speak up, ask questions, and express concerns, while relational coordination concerns how well different professional groups communicate, share goals, and align their work.
Read more
Using a qualitative process and outcome evaluation, the study examines how the simulation activities were introduced, adapted, and experienced by different staff groups, and how participants perceived their influence on collaboration and professional behaviour. Data are collected through interviews with clinical staff and managers, questionnaires measuring psychological safety and relational coordination before and after the intervention, and systematic registration of simulation activities (including who participated, what was trained, and when and where simulations took place).
By combining process evaluation with an exploration of perceived outcomes, the study aims to provide insight into how simulation-based team training functions as a behavioural intervention in complex clinical settings, and how it may support psychologically safe and well-coordinated teamwork in everyday practice.
- Conditions
- Medical Education, Simulation, Crisis Resource Management, Simulation Training, Simulation Based Medical Education, Culture
- Being tested
- Simulation-based team training
- Keywords
- Simulation-based team training, relational coordination, psychologically safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based team trainingBehavioural
Staff participates in a simulation-based training initiative
| Study group | Role | What they receive |
|---|---|---|
| Simulation intervention | Experimental | Not described Receives: Behavioral: Simulation-based team training |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological safety
Psychological safety will be assessed using the Team Psychological Safety scale (Edmondson). The scale consists of 7 items rated on a 1-7 Likert scale, with higher scores indicating greater psychological safety. The outcome will be reported as the mean questionnaire score. Qualitative interviews are not included in this outcome measure.
Measured: Baseline and immediately after the intervention period.
Relational coordination
Relational coordination will be assessed using the Relational Coordination Survey (Gittell). Items are rated on a 1-5 scale, with higher scores indicating stronger relational coordination. The outcome will be reported as the mean questionnaire score. Qualitative interviews are not included in this outcome measure.
Measured: Baseline and immediately after the intervention period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Mar 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Education, Simulation, Crisis Resource ManagementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A controlled intervention study comparing two groups.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07381270
- Sponsor's protocol ID
- InfecSIM
- Acronym
- InfecSIM
- Status last verified
- Mar 2026
- First submitted
- 15 Jan 2026
- Last updated
- 5 Jun 2026
- 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 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simulation-Based Team Training to Improve Psychological Safety and Relational Coordination in Clinical Teams
- ClinicalTrials.gov ID
- NCT07381270
- Acronym / sponsor ID
- InfecSIM / InfecSIM
- Conditions
- Medical Education, Simulation, Crisis Resource Management, Simulation Training, Simulation Based Medical Education, Culture
- Keywords
- Simulation-based team training, relational coordination, psychologically safety
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 2 Feb 2026 (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.
Simulation-based team training is increasingly used in hospitals to support teamwork and communication, particularly in situations that are complex or time-critical. While such training is known to improve observable team behaviours, less is known about how it is implemented in everyday clinical work and how it influences relational aspects of teamwork, such as psychological safety and relational coordination.
This study explores the implementation and perceived impact of a simulation-based training programme focused on infectious disease management in a hospital department. Psychological safety refers to whether staff feel safe to speak up, ask questions, and express concerns, while relational coordination concerns how well different professional groups communicate, share goals, and align their work.
Using a qualitative process and outcome evaluation, the study examines how the simulation activities were introduced, adapted, and experienced by different staff groups, and how participants perceived their influence on collaboration and professional behaviour. Data are collected through interviews with clinical staff and managers, questionnaires measuring psychological safety and relational coordination before and after the intervention, and systematic registration of simulation activities (including who participated, what was trained, and when and where simulations took place).
By combining process evaluation with an exploration of perceived outcomes, the study aims to provide insight into how simulation-based team training functions as a behavioural intervention in complex clinical settings, and how it may support psychologically safe and well-coordinated teamwork in everyday practice.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A controlled intervention study comparing two groups.
| Arm | Type | Receives |
|---|---|---|
| Simulation intervention | Experimental | Behavioral: Simulation-based team training |
| Control | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Employed in the included departments
- Profession as a doctor or nurse
Key exclusion criteria (1 listed)
- If participants are employed in both intervention and control group during the project period
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 |
|---|---|---|
| Simulation-based team trainingStaff participates in a simulation-based training initiative | Behavioural | Simulation intervention |
Primary outcome
Psychological safety
Time frame: Baseline and immediately after the intervention period.
Psychological safety will be assessed using the Team Psychological Safety scale (Edmondson). The scale consists of 7 items rated on a 1-7 Likert scale, with higher scores indicating greater psychological safety. The outcome will be reported as the mean questionnaire score. Qualitative interviews are not included in this outcome measure.
Relational coordination
Time frame: Baseline and immediately after the intervention period.
Relational coordination will be assessed using the Relational Coordination Survey (Gittell). Items are rated on a 1-5 scale, with higher scores indicating stronger relational coordination. The outcome will be reported as the mean questionnaire score. Qualitative interviews are not included in this outcome measure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Medical Education, Simulation, Crisis Resource Management
Recruiting
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Postpartum Hemorrhage, Simulation Based Medical Education
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 Simulation-based team training in people with Medical Education, Simulation, Crisis Resource Management and Simulation Training, run by University of Aarhus at 1 site in Denmark.
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: under way, not looking for participants, as of the sponsor's last update on 5 Jun 2026. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
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?
Psychological safety (time frame: Baseline and immediately after the intervention period.). The study lists 2 primary outcomes in all. 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 5 Jun 2026.