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NCT Number: NCT07381270

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Infectious Diseases, Aarhus University Hospital

Aarhus, 8200, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Simulation-based team training

Behavioral

Staff participates in a simulation-based training initiative

Primary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Simulation-Based Team Training to Improve Psychological Safety and Relational Coordination in Clinical Teams

Acronym: InfecSIM

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Feb 2, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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