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

Sponsor

University of Aarhus (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06064045

Collaborator

Central Denmark Region (Other)

1,200

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medical Education Pediatrics Patient Outcomes	Behavioral: Simulation-based team training intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Apr 1, 2024

Anticipated Study Completion Date :

Apr 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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).
No Intervention: Control arm Performing simulation as usual

Arm

Intervention/Treatment

Experimental: 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.

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).

No Intervention: Control arm

Performing simulation as usual

Outcome Measures

Primary Outcome Measures

Sick leave [Up to 30 months]
Change from before intervention to after intervention assessed by administrative human resources database
Patient safety culture [Up to three months]
Change from baseline to after intervention assessed by SAQ-DK Questionnaire
Apgar score [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Corporate HR, MidtSim, Central Denmark Region	Aarhus		Denmark

Sponsors and Collaborators

University of Aarhus
Central Denmark Region

Investigators

Principal Investigator: Anders Schram, Central Denmark Region

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT06064045

Other Study ID Numbers:

PAEDSIM

First Posted:

Oct 3, 2023

Last Update Posted:

Oct 3, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Aarhus

Simulation-based team training

Culture

Sickness absence

Study Results

No Results Posted as of Oct 3, 2023