NCT06542861

Brief 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. 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simulation-based team training with no changes - "as usual" and at a two to three times lower frequency (based on unpublished data).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:

  1. 1.Teamwork competencies measured by the team emergency assessment measure (TEAM),
  2. 2.Time (seconds) to recognition of cardiac arrest.
  3. 3.Time (seconds) to initiation of cardiopulmonary resuscitation.
  4. 4.Longest chest compression pause duration.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2024

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 7, 2024

Completed
Last Updated

August 7, 2024

Status Verified

April 1, 2024

Enrollment Period

1.2 years

First QC Date

June 19, 2024

Last Update Submit

August 5, 2024

Conditions

Keywords

In-hospital cardiac arrestMedical EducationSimulation-based trainingPediatrics

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Up to 36 months

Secondary Outcomes (2)

  • Team effectiveness

    Up to 36 months.

  • Cardiopulmonary resuscitation quality

    Up to 36 months.

Study Arms (2)

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.

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.

Interventions

The 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.

Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Missing consent to be recorded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corporate HR, MidtSim

Aarhus N, Denmark

Location

Study Officials

  • Morten S Lindhard, MD, PhD

    Randers Regional Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2024

First Posted

August 7, 2024

Study Start

April 1, 2023

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

August 7, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations