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

NCT ID: NCT06064045

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1238 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2024-10-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Simulation-based team training intervention

Intervention Type: 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).

Control arm

Performing simulation as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Central Denmark Region

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anders Schram

Role: PRINCIPAL_INVESTIGATOR

Central Denmark Region

Locations

Corporate HR, MidtSim, Central Denmark Region

Aarhus, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 40600675 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38824537 (View on PubMed)

Other Identifiers

PAEDSIM

Identifier Type: -

Identifier Source: org_study_id