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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06064045
Other study ID # PAEDSIM
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date April 1, 2023
Est. completion date April 1, 2025

Study information

Verified date September 2023
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1200
Est. completion date April 1, 2025
Est. primary completion date April 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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: 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).

Locations

Country Name City State
Denmark Corporate HR, MidtSim, Central Denmark Region Aarhus

Sponsors (2)

Lead Sponsor Collaborator
University of Aarhus Central Denmark Region

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sick leave Change from before intervention to after intervention assessed by administrative human resources database Up to 30 months
Primary Patient safety culture Change from baseline to after intervention assessed by SAQ-DK Questionnaire Up to three months
Primary Apgar score 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
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