Using Simulation to Support Staff and Improve Quality of Treatment: An Intervention Project Within Pediatrics (PAEDSIM)

January 19, 2026 updated by: University of Aarhus

Enhancing Patient Safety and Quality of Care: Study Protocol for a Simulation-based Team Training Intervention Trial

Background:

Effective teamwork and quality care are crucial for patient safety overall. Simulation-based team training offers a valuable approach to improving communication, coordination, and decision-making among healthcare professionals, leading to better outcomes and a safer healthcare environment. By evaluating the effectiveness of this training method, the project aims to contribute to the continuous improvement of healthcare delivery.

Hypothesis: Implementation of simulation-based team training in pediatric departments will lead to improved teamwork, communication, and coordination among healthcare professionals, resulting in enhanced patient outcomes and a safer healthcare environment.

Setup: From April 2023 to April 2024 a simulation-based training program will be implemented. The intervention group consists of healthcare professionals working as physicians or nurses in four pediatric departments. The intervention entails increasing the quantity of simulation-based team training within the intervention group. Additionally, measures to enhance and support simulation will be introduced within the intervention group.

Concurrently, another four pediatric departments will serve as a control group, in which no intervention will be implemented.

Both groups consist of approximately 600 healthcare professionals, contributing to a total of 1,200 participants included in this project.

Data collection:

Registration of simulation: The simulation facilitator responsible for each session completes a brief web-based questionnaire made readily accessible from all platforms by QR-code. Data includes Regional ID (unique personal identifier), gender, age, profession, simulation duration, and content, as well as learning goals.

Outcome measures include 1) patient safety culture, 2) rate of sick leave among healthcare professionals, 3) Apgar score, and 4) an intervention cost-benefit analysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1238

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

  • Denmark
      • Aarhus, Denmark
        • Corporate HR, MidtSim, Central Denmark Region

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:

  1. Employed in one of the eight included pediatric departments during the project period (April 2022 to April 2023)
  2. Profession as doctor or nurse

Exclusion Criteria:

1) 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: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention arm
The intervention entails boosting the quantity and frequency of simulation-based team training within the intervention group. Additionally, measures to enhance and support simulation will be introduced within the intervention group.
Behavioral: Simulation-based team training intervention

Participants in the intervention group will aim to participate in simulation at a higher quantity and frequency.

Moreover, the intervention group:

  1. Enrolled 15 healthcare professionals in a 3-day training program to become simulator facilitators, enabling an increase in the utilization of simulation within the group (October 2022).
  2. Organized a 2-day workshop for all pediatric simulation facilitators with the objective of establishing a more robust and standardized foundation for implementing simulation within their respective departments (March 2023).
  3. Procured essential equipment, including mannequins, SimPads, and monitors (before the intervention period).
  4. Provide simulator facilitators with access to an online repository where they can access scenarios for conducting simulations (during the intervention period).
No Intervention: Control arm
Performing simulation as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sick leave
Time Frame: Up to 30 months
Change from before intervention to after intervention assessed by administrative human resources database
Up to 30 months
Patient safety culture
Time Frame: Up to three months
Change from baseline to after intervention assessed by SAQ-DK Questionnaire
Up to three months
Apgar score
Time Frame: Up to 30 months

Change from before intervention to after intervention assessed by administrative human resources database

The Apgar score is based on a score of 1 to 10, determining how well the baby tolerated the birthing process. The higher the Apgar score, the better the baby is doing after birth
Up to 30 months

Collaborators and Investigators

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

Sponsor

University of Aarhus

Collaborators

Central Denmark Region

Investigators

  • Principal Investigator: Anders Schram, Central Denmark Region

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2023

Primary Completion (Actual)

October 1, 2024

Study Completion (Actual)

October 1, 2024

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 28, 2023

First Posted (Actual)

October 3, 2023

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PAEDSIM

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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