AzTrials
AzTrials

Cardiopulmonary ResuscitationNCT03469154

Sustainable Solutions for Paediatric Basic Life Support Training in Day Care Centres

A study testing Dyad training method and Instructor led training method in people with Cardiopulmonary Resuscitation and Education, run by Copenhagen Academy for Medical Education and Simulation.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Dyad training method and Instructor led training method
Could I receive a placebo?
No, everyone receives an active treatment
How many people
569 participants
Where
No sites listed yet
Study dates
7 Dec 2015to 5 Jul 2017
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

About this study

Official title: Sustainable Solutions for Paediatric Basic Life Support Training in Day Care Centres: A Comparative Effectiveness Trial

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.

Read more

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.

Read the detailed description

Introduction Paediatric Basic Life support (PBLS) training is essential for acquisition of resuscitation skills. Trained laypersons are more likely to provide bystander cardiopulmonary resuscitation. The skills are important if life-threatening incidents occur as immediate bystander response is needed to improve survival and neurological outcomes for critically ill children. Previously most training has been conducted by instructor-led training courses of small groups. The courses are fairly good at learning the skills, but the skills acquired still deteriorate in a period as quickly as six months. To increase survival of children there is a need for teaching PBLS skills to large communities. Instructor-led training is not suitable for this task due to the need of very large numbers of instructors, the short retention spans, the inflexibility of the course planning and the economic costs of having small groups training with an expensive instructor thus emphasising needs for alternative training strategies.

Alternative approaches to community based learning of PBLS have not been examined in larger scales and especially not in the lights of feasibility, retention and costs. Improving retention of skills or developing feasible quick retraining methods with relevant intervals for the purpose of maintaining PBLS skills remains a challenge.

This study examines these problems by conducting a study of an alternative approach to PBLS training for the community of employees in day care centres using dyad training. If successful, the training method could provide flexible training, improve retention, reduce costs and be suitable for training large communities.

Dyad training In the Dyad training method learners work together in pairs to acquire skills. The participants take turns in performing the practical skills and the other observes and gives feedback. In other medical settings dyad training has been found effective in skills training especially for novices and in short courses. The dyad training studies have been limited to small numbers of health care professional participants in simulated settings. Possible explanations of these effects include observational processing, psychomotor, cognitive and social factors and the mirror neuron system. The use of dyad partners allows learners to observe, support and feedback each other during practice and thereby reduce cognitive load and support cognitive co-construction. The active role as dyad observer has been suggested to let participants set higher goals for own performance, increase motivation by inducing a competitive component and increase responsibility for training which in all cases may enhance the cognitive processing and increase learning. The learning strategy has not been studied for workplace-based skills learning, in PBLS nor for larger groups of lay persons. Dyad training in this study is assisted and facilitated by computer based video instruction as other studies have found it to be effective for novice training. Consequently the presented learning method does not involve an instructor and presents an alternative to traditional skills training which could prove efficient, feasible, flexible and reduce costs. Secondly the training method has a potential for easy up scaling to larger groups/communities. Some studies have found positive correlations between simulation assessment and patient-related outcomes, linking the PBLS training to real life incidents.

The aim of this study is in a randomised control trial to examine if dyad training and E-learning (dyads guided by computer programme videos) as a learning model is non-inferior to instructor led training regarding acquisition of PBLS practical skills and self-efficacy in lay persons. The investigators want to examine if the dyad training positive effects described in literature can be applied to short training courses in a broader population. Second the investigators want to examine if the learning and retention of PBLS skills is affected by the training methods.

Prior to the training both groups have access to a website with videos, quizzes, pictures and text information on paediatric basic life support and foreign body airway obstruction management.

The investigators hypothesise that dyad training and E learning is non-inferior or equivalent compared to instructor led practical skills training. The hypothesis emerges from data obtained in focus group interviews stating that employees are used to work in teams, find PBLS training very important, want to engage in this form of training and lack PBLS competencies. Incidents in day care centres are handled in teams hence dyad training is similar to real life situations in day care centres and this may increase motivation and learning. If incidents requiring PBLS are to be performed in day care centres it will be in a stressful environment with reduced individual cognitive capacities thus supporting teamwork and sharing resources. This may be strengthened by the dyad training method.

Real transfer studies cannot be performed regarding PBLS but training close to realities (i.e. in groups of well-known colleagues) may facilitate easier transfer to real incidents.

Interviews have indicated that instructor-led training might boost immediate self-confidence and potentially the performance right after a course but may deteriorate fast when course and instructor support stops. It is hypothesized that the possible enhanced cognitive processing after the course suggested in dyad training may improve performance and retention of skills after the course compared to individual instructor-led training.

In addition to the analysis mentioned above elf-efficacy on acquired skills in PBLS will be examined in questionnaires as it is important for bystanders' willingness to act.

The assessment tool to assess video recorded scenario tests has been examined for validity evidence winter 2017/2018. Consequently blinded assessors are rating the videos in January through March 2018 and no analysis of the results has taken place before the clinicaltrials.gov registration.

Being tested
Dyad training method, Instructor led training method
Keywords
Layperson, Paediatric Basic life Support, education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dyad training methodOther

    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.

  • Instructor led training methodOther

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

Study groups in NCT03469154
Study groupRoleWhat they receive
Dyad trainingExperimentalThe 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
Receives: Other: Dyad training method
Instructor led trainingActive comparatorParticipants 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.
Receives: Other: Instructor led training method

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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).

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

Secondary outcomes (10)
  1. Retention test of paediatric basic life support skills assessed by standardised scenario tests

    By randomisation one third of the participants in the primary outcome 1 measure participate in a test similar to the primary outcome measure 1.

    Measured: 14 days after training

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

    By randomisation one third of the participants in the primary outcome measure 1 participate in a test similar to the primary outcome measure 1.

    Measured: 1 month after training

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

    By randomisation one third of the participants in the primary outcome measure 1 participate in a test similar to the primary outcome measure 1.

    Measured: 3 months after training

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

    The secondary outcome 1 participants participate in a test similar to the primary outcome measure (outcome 2).

    Measured: 14 days after training

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

    The secondary outcome 2 participants participate in a test similar to the primary outcome measure (outcome 2).

    Measured: 1 month after training

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

    The secondary outcome 3 participants participate in a test similar to the primary outcome measure (outcome 2).

    Measured: 3 months after training

  7. Self-efficacy by questionaires

    All participants examined for self-efficacy on foreign body airway obstruction and paediatric basic life support skills. Immediately after the training course.

    Measured: Up to 10 minutes after training

  8. Self-efficacy by questionaires

    Secondary outcome 1 participants examined by questionaires on self-efficacy on foreign body airway obstruction and paediatric basic life support skills. Immediately before the retention tests.

    Measured: 14 days after training

  9. Self-efficacy by questionaires

    Secondary outcome 2 participants examined by questionaires on self-efficacy on foreign body airway obstruction and paediatric basic life support skills. Immediately before the retention tests.

    Measured: 1 month after training

  10. Self-efficacy by questionaires

    Secondary outcome 3 participants examined by questionaires on self-efficacy on foreign body airway obstruction and paediatric basic life support skills. Immediately before the retention tests.

    Measured: 3 months after training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2018
  2. Study start7 Dec 2015
  3. Primary completion5 Apr 2017
  4. Study completion5 Jul 2017

Resources

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
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
569 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03469154
Sponsor's protocol ID
1
Status last verified
Mar 2018
First submitted
22 Feb 2018
Last updated
22 Mar 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29347956

Questions about this trial

What is this clinical trial studying?

A study testing Dyad training method and Instructor led training method in people with Cardiopulmonary Resuscitation and Education, run by Copenhagen Academy for Medical Education and Simulation.

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 2 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

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?

Paediatric basic life support skill level immediately after training (time frame: Participant performs the tests of approximately 3-5 minutes, up to one hour after the course finalization.). The study lists 2 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 NCT03469154, which also lists 1 linked publication.

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 Mar 2018.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in