- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07381270
Using Simulation-based Team Training to Improve Psychological Safety and Relational Coordination as Well as Conducting a Process Evaluation (InfecSIM)
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Aarhus, Denmark, 8200
- Department of Infectious Diseases, Aarhus University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Employed in the included departments
- Profession as a doctor or nurse
Exclusion Criteria:
- If participants are employed in both intervention and control group during the project period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control
|
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Experimental: Simulation intervention
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Staff participates in a simulation-based training initiative
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and immediately after the intervention period.
|
|
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.
|
Baseline and immediately after the intervention period.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Process evaluation
Time Frame: From intervention start until immediately after the intervention period.
|
The process evaluation examines how the simulation-based team training was implemented, including organisation, adaptation, and contextual conditions shaping delivery and participation.
Data are collected through qualitative interviews and systematic registration of simulation activities.
|
From intervention start until immediately after the intervention period.
|
|
Qualitative explanatory evaluation of intervention mechanisms
Time Frame: Immediately after the intervention period.
|
Qualitative interviews will explore how staff and managers describe changes in everyday work practices following the simulation-based team training and how these changes are understood within the local clinical context.
Outcomes will be reported as qualitative themes.
|
Immediately after the intervention period.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- InfecSIM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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