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Completed

NCT Number: NCT06064045

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

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.

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Key information

Conditions

Medical Education Patient Outcomes Pediatrics

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corporate HR, MidtSim, Central Denmark Region

Aarhus, Denmark

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Employed in one of the eight included pediatric departments during the project period (April 2022 to April 2023)
  • Profession as 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 intervention

Behavioral

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

Moreover, the intervention group:

  • 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).
  • 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).
  • Procured essential equipment, including mannequins, SimPads, and monitors (before the intervention period).
  • Provide simulator facilitators with access to an online repository where they can access scenarios for conducting simulations (during the intervention period).

Primary outcomes

  1. Sick leave

    Time frame: Up to 30 months

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

  2. Patient safety culture

    Time frame: Up to three months

    Change from baseline to after intervention assessed by SAQ-DK Questionnaire

  3. 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

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Collaborators

  • Central Denmark Region

Registry information

Official study title

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

Acronym: PAEDSIM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2023
Registry last updated
Jan 22, 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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