NCT03469154

Brief Summary

In a randomised non-inferiority trial the investigators examine two training interventions to train paediatric basic life support to laypersons: Dyad training vs Instructor led training. For dyad training two participants are guided by video instructions and perform exercises on children resuscitation manikins. The participants take turn to complete the exercises and provide feedback to their peer. The duration is up to 50 minutes Instructor led training of paediatric basic life support in instructor led courses with up to 6 participants per course with hands-on training on children resuscitation manikin. The duration of the courses is up to two hours. Instructor led training represents the common gold standard for training Paediatric Basic Life Support, however it is inflexible and uses a lot of resources. Dyad training provides a low cost solution with improved flexibility. Consequently a non-inferiority design is chosen as the benefits of dyad training with the same learning outcomes favours the dyad training method. Prior to the training both groups are informed about and have access to a website with videos, quizzes, pictures and text information on paediatric basic life support and foreign body airway obstruction management.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
569

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2015

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

December 7, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
Last Updated

March 22, 2018

Status Verified

March 1, 2018

Enrollment Period

1.3 years

First QC Date

February 22, 2018

Last Update Submit

March 21, 2018

Conditions

Keywords

LaypersonPaediatric Basic life Supporteducation

Outcome Measures

Primary Outcomes (2)

  • Paediatric basic life support skill level immediately after training

    All participants participate in video recorded standardised scenario tests on resuscitation manikins just after the training course for paediatric basic life support. The videos are rated by blinded assessors using a developed assessment tool for laypersons paediatric basic life support (validity evidence study currently under preparation for publication) - The assessment tool is based on internationally identified assessment items from a delphi consensus study (see references).

    Participant performs the tests of approximately 3-5 minutes, up to one hour after the course finalization.

  • Foreign body airway obstruction management skill level immediately after training

    All participants participate in video recorded standardised scenario tests on resuscitation manikins just after the training course for foreign body airway obstruction management. The videos are rated by blinded assessors using a developed assessment tool for laypersons paediatric basic life support (validity evidence study currently under preparation for publication) - The assessment tool is based on internationally identified assessment items from a delphi consensus study (see references).

    Participant performs the tests of approximately 3-5 minutes up to one hour after the course finalization.

Secondary Outcomes (10)

  • Retention test of paediatric basic life support skills assessed by standardised scenario tests

    14 days after training

  • Retention test of paediatric basic life support skills assessed by standardised scenario tests

    1 month after training

  • Retention test of paediatric basic life support skills assessed by standardised scenario tests

    3 months after training

  • Retention test of foreign body airway obstruction management skills assessed by standardised scenario tests

    14 days after training

  • Retention test of foreign body airway obstruction management skills assessed by standardised scenario tests

    1 month after training

  • +5 more secondary outcomes

Study Arms (2)

Dyad training

EXPERIMENTAL

The participants in this arm will train in teams of two. Participants will be instructed in paediatric basic life support by instructional videos in a computer programme and train on children resuscitation manikins. Training involves recognition of cardiac arrest, cardio-pulmonary resuscitation and foreign body airway obstruction management. The training involves series of short video clips and following exercises. Each participant performs the exercise and the other gives feedback. Afterwards roles are changed. The procedure is done for all exercises after a video clip. The duration of the training is maximum 50 minutes

Other: Dyad training method

Instructor led training

ACTIVE COMPARATOR

Participants train in courses of up to 6 participants with an instructor. Training content is identical to dyad training content involving: recognition of cardiac arrest, cardio-pulmonary resuscitation and foreign body airway obstruction management. Skills are instructed by an instructor using af 4 step approach (1. show skills, 2. show with explanation, 3. participants instruct instructor, 4. participants performs the skills on resuscitation manikins). Training is maximum two hours but course duration is adjusted to number of participants two allow for similar hands-on time per participant as in the experimental arm.

Other: Instructor led training method

Interventions

The training model for paediatric basic life support for laypersons involves a course based on pairs training together guided by instructional videos and with hands-on practice on resuscitation manikins.

Dyad training

The training model for paediatric basic life support for laypersons involves a course led by an instructor including hands-on practice on resuscitation manikins.

Instructor led training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Working with children under seven years of age for \>20 hours/week
  • Physically able to participate in tests

You may not qualify if:

  • Any basic life support training within 1 year from training day
  • Trained health professional

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hasselager AB, Lauritsen T, Kristensen T, Bohnstedt C, Sonderskov C, Ostergaard D, Tolsgaard MG. What should be included in the assessment of laypersons' paediatric basic life support skills? Results from a Delphi consensus study. Scand J Trauma Resusc Emerg Med. 2018 Jan 18;26(1):9. doi: 10.1186/s13049-018-0474-5.

    PMID: 29347956BACKGROUND

Study Officials

  • Asbjørn Hasselager, MD

    Copenhagen Academy for Medical Education and Simulation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
After training participants demonstrate skills in a standardised scenario test with children resuscitation manikins. All tests are video recorded. Participants in videos identified by a unique id number. Training method is not mentioned in videos. Assessors have no knowledge on the relation between group and unique id (are blinded for the interventions). Assessors assess videos of all participants in a randomised order .
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two parallel groups. Participants randomised to either dyad training or instructor led training. Dyad training in pairs guided by instructional videos Instructor led training with maximum 6 participants per instructor.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 22, 2018

First Posted

March 19, 2018

Study Start

December 7, 2015

Primary Completion

April 5, 2017

Study Completion

July 5, 2017

Last Updated

March 22, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share