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

Pediatrics Clinical Trial

— PAEDSIM  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06064045
• Other study ID #: PAEDSIM
• Status: Active, not recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Medical Education
• Patient Outcomes
• Pediatrics

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