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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06064045
Acronym
PAEDSIM
Enrollment
1238
Registered
2023-10-03
Start date
2023-04-01
Completion date
2024-10-01
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medical Education, Patient Outcomes, Pediatrics

Keywords

Simulation-based team training, Culture, Sickness absence

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.

Interventions

BEHAVIORALSimulation-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).

Sponsors

University of Aarhus
Lead SponsorOTHER
Central Denmark Region
CollaboratorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Sick leaveUp to 30 monthsChange from before intervention to after intervention assessed by administrative human resources database
Patient safety cultureUp to three monthsChange from baseline to after intervention assessed by SAQ-DK Questionnaire
Apgar scoreUp to 30 monthsChange 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

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORAnders Schram

Central Denmark Region

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026