Clinical trial NCT06064045: Using Simulation to Support Staff and Improve Quality of Treatment: An Intervention Project Within Pediatrics
Official title: Enhancing Patient Safety and Quality of Care: Study Protocol for a Simulation-based Team Training Intervention Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Medical Education
Pediatrics
Patient Outcomes
Keywords: Simulation-based team training
Culture
Sickness absence
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Central Denmark Region
First posted: 2023-10-03
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A controlled intervention study comparing two groups each consisting of four pediatric departments.

Each group consists of approximately 600 participants
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Sick leave
timeFrame: Up to 30 months
measure: Patient safety culture
timeFrame: Up to three months
measure: Apgar score
timeFrame: Up to 30 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Corporate HR, MidtSim, Central Denmark Region
Study officials:
affiliation: Central Denmark Region
name: Anders Schram
role: PRINCIPAL_INVESTIGATOR
References: