Medical EducationNCT06542861
Effects of High-Frequency In Situ Simulation-based Team Training on Clinical Performance During Pediatric Cardiac Arrest
A study testing High-frequency simulation-based team training in people with Medical Education and Simulation-based Training, run by University of Aarhus at 1 site in Denmark.
Trial summary
Cardiac arrest in hospitalized children is a rare occurrence in general and for each healthcare professional in particular, making lack of routine in performing cardiopulmonary resuscitation a challenge. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medical Education, Simulation-based Training, In-hospital Cardiac Arrest
- What is being tested?
- High-frequency simulation-based team training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2023to 30 Jun 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Healthcare professionals (doctor or nurse) employed in one of the eight pediatric departments in Central Denmark Region og Southern Denmark Region during the project period April 1st 2023 to April 1st 2024.
Who cannot join
- Missing consent to be recorded
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of in Situ Simulation-based Team Training on Clinical Performance During Pediatric Cardiac Arrest: An Intervention Study Comparing Two Danish Regions
Cardiac arrest in hospitalized children is a rare occurrence in general and for each healthcare professional in particular, making lack of routine in performing cardiopulmonary resuscitation a challenge. Mortality and morbidity following cardiac arrest depend on the technical (medical knowledge, procedures, etc.) and non-technical (team leadership, communication, etc.) skills performed by the medical team. Simulation-based team training is a well-known and effective method to improve team performance in high-stake and time-sensitive situations, without putting actual patients at risk. Unfortunately, studies show that skills obtained during simulation-based team training decline within a few months. However, recent observational studies have demonstrated improved technical pediatric basic life support skills after short simulation sessions with a high frequency of repeat. The healthcare professionals in these studies are limited to selected groups and tests are performed exclusively on skill stations.
In this study, the effects of a novel high-frequency training program will be investigated. A controlled intervention study in two comparable Danish regions will be conducted. Healthcare professionals in four pediatric departments in the intervention region will participate in the high-frequency training program. Healthcare professionals in four pediatric departments in the control region will continue simulation-based team training with no changes - "as usual" and at a two to three times lower frequency (based on unpublished data). Both groups consist of approximately 600 healthcare professionals, contributing to a total of 1,200 participants included in this project.
Read more
Hypotheses: high-frequency training will improve primary outcomes during in-situ simulated pediatric in-hospital cardiac arrest as specified:
- Teamwork competencies measured by the team emergency assessment measure (TEAM),
- Time (seconds) to recognition of cardiac arrest.
- Time (seconds) to initiation of cardiopulmonary resuscitation.
- Longest chest compression pause duration.
Data collection. To assess clinical performance in both regions unannounced in-situ (in own department with usage of own equipment) simulations of pediatric cardiac arrest will be performed and recorded on video.
- Conditions
- Medical Education, Simulation-based Training, In-hospital Cardiac Arrest, Pediatrics, in Situ Simulation
- Being tested
- High-frequency simulation-based team training
- Keywords
- In-hospital cardiac arrest, Medical Education, Simulation-based training, Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency simulation-based team trainingOther
The intervention is a standardized high-frequency training program as described in intervention arm. It is supported by four preliminary initiatives:
- 15 extra pediatric simulation facilitators were educated, bringing the total number up to 40.
- A two-day pre-intervention workshop for all pediatric simulation facilitators.
- A "scenario bank" containing standardized scenarios on common pediatric and neonatal emergencies was created and made accessible for simulation facilitators to support consistency in the intervention.
- Purchase of equipment. Eight Leardal manikins. Four SimPads. Four monitors. During the intervention year, these will rotate between the pediatric departments.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Healthcare professionals (doctors and nurses) employed in one of four pediatric departments in the Central Denmark Region. N = approximately 600.
From April 1st 2023 to April 1st 2024 healthcare professionals in the intervention arm will be exposed to a high-frequency training program, in which each healthcare professional will attend four SBTT sessions in one year, approx. three months apart. Three-month intervals were chosen based on knowledge of retention of technical skills. Receives: Other: High-frequency simulation-based team training |
| Control | No intervention | Healthcare professionals (doctors and nurses) employed in one of four pediatric departments in the Region of Southern Denmark. N = approximately 600. No special training program. Participants in the control region will continue simulation-based team training "as usual" with no changes in training frequency. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Teamwork competences
Global team score. Assessed in both regions pre- and post-intervention. Assessed according to Team Emergency Assessment Measure (TEAM). Score range from 1-54. 1 being the lowest score and 54 the highest.
Measured: Up to 36 months
Time to diagnosis of cardiac arrest
Time (seconds) until cardiac arrest is recognized, assessed in both regions by pre- and post-intervention video recordings of unannounced in-situ simulations of pediatric cardiac arrest.
Measured: Up to 36 months
Time to initiation of cardiopulmonary resuscitation
Time (seconds) until cardiopulmonary resuscitation within standard guidelines for neonates/children is initiated, assessed in both regions by pre- and post-intervention video recordings of unannounced in-situ simulations of pediatric cardiac arrest.
Measured: Up to 36 months
Longest chest compression pause duration
Chest compression pause durations will be assessed in both regions by pre- and post-intervention video recordings of unannounced in-situ simulations of pediatric cardiac arrest.
Measured: Up to 36 months
Secondary outcomes (2)
Team effectiveness
Time (seconds) to: call for help, arrival of defibrillator, first rhythm check. Will be assessed in both regions by pre- and post-intervention video recordings of unannounced in-situ simulations of pediatric cardiac arrest.
Measured: Up to 36 months.
Cardiopulmonary resuscitation quality
Proportion of compressions, and ventilations within guideline recommendations for depth/rate and tidal volumes, respectively.
Measured: Up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Apr 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical EducationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Corporate HR, MidtSim, Central Denmark Region
- Responsible party
- Sponsor
- Investigators
- Morten S Lindhard, MD, PhD, Study director, Randers Regional Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542861
- Sponsor's protocol ID
- 1-16-02-77-23
- Status last verified
- Apr 2024
- First submitted
- 19 Jun 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of in Situ Simulation-based Team Training on Clinical Performance During Pediatric Cardiac Arrest: An Intervention Study Comparing Two Danish Regions
- ClinicalTrials.gov ID
- NCT06542861
- Acronym / sponsor ID
- 1-16-02-77-23
- Conditions
- Medical Education, Simulation-based Training, In-hospital Cardiac Arrest, Pediatrics, in Situ Simulation
- Keywords
- In-hospital cardiac arrest, Medical Education, Simulation-based training, Pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,200 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Corporate HR, MidtSim, Central Denmark Region
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 7 Aug 2024 (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.
Cardiac arrest in hospitalized children is a rare occurrence in general and for each healthcare professional in particular, making lack of routine in performing cardiopulmonary resuscitation a challenge. Mortality and morbidity following cardiac arrest depend on the technical (medical knowledge, procedures, etc.) and non-technical (team leadership, communication, etc.) skills performed by the medical team. Simulation-based team training is a well-known and effective method to improve team performance in high-stake and time-sensitive situations, without putting actual patients at risk. Unfortunately, studies show that skills obtained during simulation-based team training decline within a few months. However, recent observational studies have demonstrated improved technical pediatric basic life support skills after short simulation sessions with a high frequency of repeat. The healthcare professionals in these studies are limited to selected groups and tests are performed exclusively on skill stations.
In this study, the effects of a novel high-frequency training program will be investigated. A controlled intervention study in two comparable Danish regions will be conducted. Healthcare professionals in four pediatric departments in the intervention region will participate in the high-frequency training program. Healthcare professionals in four pediatric departments in the control region will continue simulation-based team training with no changes - "as usual" and at a two to three times lower frequency (based on unpublished data). Both groups consist of approximately 600 healthcare professionals, contributing to a total of 1,200 participants included in this project.
Hypotheses: high-frequency training will improve primary outcomes during in-situ simulated pediatric in-hospital cardiac arrest as specified:
- Teamwork competencies measured by the team emergency assessment measure (TEAM),
- Time (seconds) to recognition of cardiac arrest.
- Time (seconds) to initiation of cardiopulmonary resuscitation.
- Longest chest compression pause duration.
Data collection. To assess clinical performance in both regions unannounced in-situ (in own department with usage of own equipment) simulations of pediatric cardiac arrest will be performed and recorded on video.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: High-frequency simulation-based team trainingHealthcare professionals (doctors and nurses) employed in one of four pediatric departments in the Central Denmark Region. N = approximately 600. From April 1st 2023 to April 1st 2024 healthcare professionals in the intervention arm will be exposed to a high-frequency training program, in which each healthcare professional will attend four SBTT sessions in one year, approx. three months apart. Three-month intervals were chosen based on knowledge of retention of technical skills. |
| Control | No intervention | –Healthcare professionals (doctors and nurses) employed in one of four pediatric departments in the Region of Southern Denmark. N = approximately 600. No special training program. Participants in the control region will continue simulation-based team training "as usual" with no changes in training frequency. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthcare professionals (doctor or nurse) employed in one of the eight pediatric departments in Central Denmark Region og Southern Denmark Region during the project period April 1st 2023 to April 1st 2024.
Key exclusion criteria (1 listed)
- Missing consent to be recorded
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 |
|---|---|---|
| High-frequency simulation-based team trainingThe intervention is a standardized high-frequency training program as described in intervention arm. It is supported by four preliminary initiatives: 1. 15 extra pediatric simulation facilitators were educated, bringing the total number up to 40. 2. A two-day pre-intervention workshop for all pediatric simulation facilitators. 3. A "scenario bank" containing standardized scenarios on common pediatric and neonatal emergencies was created and made accessible for simulation facilitators to support consistency in the intervention. 4. Purchase of equipment. Eight Leardal manikins. Four SimPads. Four monitors. During the intervention year, these will rotate between the pediatric departments. | Other | Intervention |
Primary outcome
Teamwork competences
Time frame: Up to 36 months
Global team score. Assessed in both regions pre- and post-intervention. Assessed according to Team Emergency Assessment Measure (TEAM). Score range from 1-54. 1 being the lowest score and 54 the highest.
Time to diagnosis of cardiac arrest
Time frame: Up to 36 months
Time (seconds) until cardiac arrest is recognized, assessed in both regions by pre- and post-intervention video recordings of unannounced in-situ simulations of pediatric cardiac arrest.
Time to initiation of cardiopulmonary resuscitation
Time frame: Up to 36 months
Time (seconds) until cardiopulmonary resuscitation within standard guidelines for neonates/children is initiated, assessed in both regions by pre- and post-intervention video recordings of unannounced in-situ simulations of pediatric cardiac arrest.
Longest chest compression pause duration
Time frame: Up to 36 months
Chest compression pause durations will be assessed in both regions by pre- and post-intervention video recordings of unannounced in-situ simulations of pediatric cardiac arrest.
2 secondary outcomes
Team effectiveness
Time frame: Up to 36 months.
Cardiopulmonary resuscitation quality
Time frame: Up to 36 months.
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 7 Aug 2024.
- 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.
Morten S Lindhard, MD, PhD study director
Randers Regional Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency simulation-based team training in people with Medical Education and Simulation-based Training, 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 1 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 7 Aug 2024. 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?
Teamwork competences (time frame: Up to 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2024.