Pedagogical Aspects on Training in Basic Life Support

NCT ID: NCT03618888

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2623 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-01
• Study Completion Date: 2019-12-31

Brief Summary

Cardio vascular disease (CVD) including out-of-hospital cardiac arrest (OHCA) is still the leading cause of death in a global perspective. Start of cardiopulmonary resuscitation (CPR) with automated external defibrillator (AED) may double or quadruple survival. Scientific research on education in Basic Life Support (BLS) in the society is active in different part of Europe but low in Sweden. The aim of this study is to investigate the effectiveness and retention after different training interventions in BLS and willingness to act in a real-life cardiac arrest situation in the society of Sweden, based on European Resuscitation Council (ERC) guidelines. This is an experimental cluster randomized trial, including participants from a BLS education project in Sweden.

Detailed Description

Introduction: The single most important factor for survival from sudden cardiac arrest (SCA) is to minimize the time from cardiac arrest to cardiopulmonary resuscitation (CPR) and to provide an electric chock through the heart with an automated external defibrillator (AED). Early start with CPR-AED increases the chance of survival two to four times. It is therefore important that as many people as possible have knowledge to quickly identify SCA and to start CPR-AED.

In this research, education efforts are directed for the adult public at workplaces in Sweden. The Investigator have designed an intervention in accordance to guidelines from European Resuscitation Council (ERC) and the Swedish national education for Basic Life Support (BLS).

This is a cluster randomized trial primarily comparing in the first study, instructor-led training as the control group and self-learning training as the experimental group. In the second study the Investigator plan to compare a preparatory web-education on CVD before the BLS training versus no web-education before the BLS. The Investigator have conducted quality tests on practical skills on BLS, administered questionnaires to the participants about theoretical knowledge, self-assessed confidence and willingness to act in a real-life SCA situation. It is crucial to be able to identify factors that affect knowledge and retention after BLS training and the willingness to intervene in an acute situation.

Background: With modern IT technology, several different options and learning strategies are available. At the same time pedagogical thoughts have emerged on learning. Education can be instructor-led or self-directed and with preparatory courses for theoretical knowledge. The quality of BLS skills and theoretical knowledge can be measured through validated instruments. Against this background, the research goal is to identify how the study can improve retention and which training methods for BLS that should be recommended for the public in the future.

Objectives: The overall objective is to increase survival from OHCA. The aim is to identify factors that affect retention and contributes to intended practical skills, theoretical knowledge and willingness to act after BLS training and whether these goals are affected by the type of training intervention.

Hypothesis: The main hypothesis is that retention of practical skills after BLS training is affected by the type of educational intervention. The hypothesis in the first study is that an instructor present at the time of training have a positive impact on retention six months after the intervention compared to self-directed training. In the second study the hypothesis is that a preparatory web-education on CVD before the BLS has a positive impact on retention six months after intervention compared to no web-education.

Questions: The Primary question is which intervention is most effective for the total score and contributes to intended practical skills and adherence to protocol, the BLS algorithm, six months after the intervention. Secondary questions deal with if other variables such as practical skills, theoretical knowledge, self-assessed confidence and willingness to intervene in a SCA situation are affected when comparing each intervention both direct after and six months after training.

Method: Voluntary, participants from a BLS project at workplaces in Sweden have been included. The participants have been randomized from a randomization list and organized for the study, from an independent coordinator. After training and at six months, a quantitative approach and data collection measured the quality of practical skills in a simulated SCA scenario, on a Laerdal Resusci Anne manikin, connected to the PCSkillReporting system. The assessor was blinded for the type of training intervention. At data collection, the variables were structured according to a modified international quality test, Cardiff Test of basic life support and automated external defibrillation (Cardiff Test) that scored adherence to the treatment algorithm and practical skills. The modified Cardiff Test included 19 variables with a total score of 70 points. A questionnaire scored theoretical knowledge, self-assessed confidence and willingness to act in a real-life situation. At the practical quality tests, the total score was the primary endpoint with other individual variables as the secondary endpoint.

Study population: Strategic sampling was used to include participants from different workplaces in a number of counties in Sweden.

Planned Studies: 1) Self-learning training versus Instructor-led training. 2) A preparatory web-education on CVD before the BLS training versus no web-education before the BLS training. 3) A register study on bystander activity 4) Instructor-led training versus subgroups of training from the BLS intervention project.

Statistics: All statistical analyses will be analysed in SASforwindows and calculated on a cluster level with an alpha level of five percent.

Ethical considerations: Ethical principles for research are carefully considered in the research process. Ethical vetting from Ethical Review of Research, involving Humans is approved (Regional Ethical Review Board in Gothenburg, diaries number 134-14) and Guidelines from the Swedish Research Council, Good Research Practice is actively used. Information has been given both individually to all participants and to the working places. All participant had to read and sign a personal consent form before participating. The result will be published according to the Declaration of Helsinki.

Conditions

Basic Life Support

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Instructor-led training

Instructor-led training contents a supervised practical training for BLS, facilitated by a certified instructor.

Group Type: ACTIVE_COMPARATOR

Instructor-led training

Intervention Type: OTHER

The Instructor-led training contents a supervised practical training with a standard kit for training in BLS

Self-learning training

Self-learning training is self-directed and contents practical training for BLS

Group Type: EXPERIMENTAL

Self-learning training

Intervention Type: OTHER

The self-learning training contents a standard kit for self-directed training in BLS

Interventions

Instructor-led training

The Instructor-led training contents a supervised practical training with a standard kit for training in BLS

Intervention Type: OTHER

Self-learning training

The self-learning training contents a standard kit for self-directed training in BLS

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adults in society over eighteen years old
• Working at workplaces outside hospital
• Without training in BLS or within the past five years
• A completed and signed consent form.

Exclusion Criteria

• Participants younger than 18 years old
• Undergone training on BLS within the past five years
• Working at hospital as health care personnel
• Do not want to participate

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swedish Heart Lung Foundation

OTHER

Sponsor Role: collaborator

University of Boras

OTHER

Sponsor Role: lead

Responsible Party

Helene Bylow

RNAN, Master of Pedagogy, PhD Student, University of Gothenburg, University of Boras

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johan D Herlitz, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Borås Sweden

Locations

University of Borås Sweden

Borås, , Sweden

Countries

Sweden

References

Bylow H, Karlsson T, Lepp M, Claesson A, Lindqvist J, Svensson L, Herlitz J. Learning Outcome After Different Combinations of Seven Learning Activities in Basic Life Support on Laypersons in Workplaces: a Cluster Randomised, Controlled Trial. Med Sci Educ. 2020 Nov 18;31(1):161-173. doi: 10.1007/s40670-020-01160-3. eCollection 2021 Feb.

Reference Type: DERIVED

PMID: 34457876 (View on PubMed)

Bylow H, Karlsson T, Claesson A, Lepp M, Lindqvist J, Herlitz J. Self-learning training versus instructor-led training for basic life support: A cluster randomised trial. Resuscitation. 2019 Jun;139:122-132. doi: 10.1016/j.resuscitation.2019.03.026. Epub 2019 Mar 26.

Reference Type: DERIVED

PMID: 30926451 (View on PubMed)

Other Identifiers

Johan Herlitz

Identifier Type: -

Identifier Source: org_study_id