NCT07381270

Brief 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 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
21mo left

Started Mar 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress42%
Mar 2025Jan 2028

Study Start

First participant enrolled

March 1, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

February 2, 2026

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

January 15, 2026

Last Update Submit

January 23, 2026

Conditions

Keywords

Simulation-based team trainingrelational coordinationpsychologically safety

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and immediately after the intervention period.

Other Outcomes (2)

  • Process evaluation

    From intervention start until immediately after the intervention period.

  • Qualitative explanatory evaluation of intervention mechanisms

    Immediately after the intervention period.

Study Arms (2)

Simulation intervention

EXPERIMENTAL
Behavioral: Simulation-based team training

Control

NO INTERVENTION

Interventions

Staff participates in a simulation-based training initiative

Simulation intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Employed in the included departments
  • Profession as a doctor or nurse

You may not qualify if:

  • If participants are employed in both intervention and control group during the project period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Diseases, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A controlled intervention study comparing two groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 15, 2026

First Posted

February 2, 2026

Study Start

March 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

January 1, 2028

Last Updated

February 2, 2026

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations