Using Simulation-based Team Training to Improve Psychological Safety and Relational Coordination as Well as Conducting a Process Evaluation (InfecSIM)

January 23, 2026 updated by: University of Aarhus

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

Study Type

Interventional

Enrollment (Estimated)

120

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

      • Aarhus, Denmark, 8200
        • Department of Infectious Diseases, Aarhus University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

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: 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
Experimental: Simulation intervention
Staff participates in a simulation-based training initiative

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

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

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)

March 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

January 15, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

February 2, 2026

Study Record Updates

Last Update Posted (Actual)

February 2, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

March 1, 2025

More Information

Terms related to this study

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.

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