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

NCT06064045 | Completed

• 1 other identifier: PAEDSIM
• Study Type: interventional
• Target: 1,238
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medical Education; Pediatrics; Patient Outcomes

Keywords

Simulation-based team training; Culture; Sickness absence

Outcome Measures

Primary Outcomes (3)

• Sick leave

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

  Up to 30 months

• Patient safety culture

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

  Up to three months

• 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

Study Arms (2)

Intervention arm

EXPERIMENTAL

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

Control arm

NO INTERVENTION

Performing simulation as usual

Interventions

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: 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).

Intervention arm

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Central Denmark Region: collaborator

Study Sites (1)

Corporate HR, MidtSim, Central Denmark Region

Aarhus, Denmark

Location

Related Publications (2)

• Schram AL, Bonne NL, Henriksen TB, Hertel NT, Lindhard MS. Factors associated with participation in simulation-based training. Dan Med J. 2025 Jun 12;72(7):A12240914. doi: 10.61409/A12240914.

  PMID: 40600675 DERIVED

• Schram A, Bonne NL, Henriksen TB, Paltved C, Hertel NT, Lindhard MS. Simulation-based team training for healthcare professionals in pediatric departments: study protocol for a nonrandomized controlled trial. BMC Med Educ. 2024 Jun 1;24(1):607. doi: 10.1186/s12909-024-05602-z.

  PMID: 38824537 DERIVED

Study Officials

• Anders Schram

  Central Denmark Region

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A controlled intervention study comparing two groups each consisting of four pediatric departments. Each group consists of approximately 600 participants

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: October 3, 2023
• Study Start: April 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 22, 2026

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)