Medical EducationPAEDSIMNCT06064045
Using Simulation to Support Staff and Improve Quality of Treatment: An Intervention Project Within Pediatrics
A study testing Simulation-based team training intervention in people with Medical Education and Pediatrics, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Medical Education, Pediatrics, Patient Outcomes
- What is being tested?
- Simulation-based team training intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,238 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2023to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Employed in one of the eight included pediatric departments during the project period (April 2022 to April 2023)
- Profession as doctor or nurse
Who cannot join
- 1) If participants are employed in both intervention and control group during the project period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Patient Safety and Quality of Care: Study Protocol for a Simulation-based Team Training Intervention Trial
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.
Read more
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
- Being tested
- Simulation-based team training intervention
- Keywords
- Simulation-based team training, Culture, Sickness absence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-based team training interventionBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Simulation-based team training intervention |
| Control arm | No intervention | Performing simulation as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sick leave
Change from before intervention to after intervention assessed by administrative human resources database
Measured: Up to 30 months
Patient safety culture
Change from baseline to after intervention assessed by SAQ-DK Questionnaire
Measured: 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
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start1 Apr 2023
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A controlled intervention study comparing two groups each consisting of four pediatric departments. Each group consists of approximately 600 participants
- Masking
- None (open label)
- Enrolment
- 1,238 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Anders Schram, Principal investigator, Central Denmark Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06064045
- Sponsor's protocol ID
- PAEDSIM
- Acronym
- PAEDSIM
- Status last verified
- Sep 2023
- First submitted
- 21 Sep 2023
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40600675Schram 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.
PubMed 38824537
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Patient Safety and Quality of Care: Study Protocol for a Simulation-based Team Training Intervention Trial
- ClinicalTrials.gov ID
- NCT06064045
- Acronym / sponsor ID
- PAEDSIM / PAEDSIM
- Conditions
- Medical Education, Pediatrics, Patient Outcomes
- Keywords
- Simulation-based team training, Culture, Sickness absence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,238 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Central Denmark Region
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A controlled intervention study comparing two groups each consisting of four pediatric departments. Each group consists of approximately 600 participants
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Behavioral: Simulation-based team training interventionThe 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. |
| Control arm | No intervention | –Performing simulation as usual |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Employed in one of the eight included pediatric departments during the project period (April 2022 to April 2023)
- Profession as doctor or nurse
Key exclusion criteria (1 listed)
- 1) If participants are employed in both intervention and control group during the project period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation-based team training interventionParticipants 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). | Behavioural | Intervention arm |
Primary outcome
Sick leave
Time frame: Up to 30 months
Change from before intervention to after intervention assessed by administrative human resources database
Patient safety culture
Time frame: Up to three months
Change from baseline to after intervention assessed by SAQ-DK Questionnaire
Apgar score
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Derived from this study: PubMed 40600675Schram 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.
- Derived from this study: PubMed 38824537Schram 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Schram principal investigator
Central Denmark Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-based team training intervention in people with Medical Education and Pediatrics, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sick leave (time frame: Up to 30 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06064045, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2026.