Self-learning vs Instructor-led Learning in BLS

January 7, 2020 updated by: University Hospital Inselspital, Berne

Self-learning Versus Instructor-led Learning in Basic Life Support Training - A Randomized Controlled Trial

This study investigates whether there is a difference in the BLS skills in first year medical students directly after training and three months later, when randomly assigned to self-learning versus instructor-led training courses.

Study Overview

Status

Completed

Conditions

Detailed Description

This is a randomized controlled trial investigating whether self-learning versus instructor-led learning results in the same BLS skills in first year medical students directly after training and three months later.

When participants attend the "Erweiterte Erste Hilfe für Studierende der Humanmedizin" they will receive a short introduction about the study. The investigators will invite all first year students to participate in the study. As the study is voluntarily, participants need to sign a written informed consent. After that, the investigators will randomize the students to either group A or Group B. Group A will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching) and group B will train without supervision. The participants in group B will not be allowed to communicate with each other during the training and they will be prevented from watching each other. The training will take about 30 minutes for each group. Directly after the training each group will be tested and the printed report form from the Laerdal Skill Reporter will be obtained for each participant. In the test the students will perform CPR in a simulated scenario as a first responder. The scenario is: "A male person has collapsed at the railway station." The participant should start CPR as learned in the training. During the CPR a departmental research fellow will observe the study participants and record BLS/AED actions on a scoring sheet.

The investigators will record three cycles of two minutes CPR (with five times 30:2 compression : ventilation intervals, as recommended by the current international resuscitation guidelines). During the three cycles an AED will be delivered and the study participant has to apply the AED and deliver a shock - after three cycles the study terminates.

After the BLS/AED competence testing, both groups will continue the rest of their first aid course together and the first part of the study ends. Three months later, the investigators will repeat the same scenario over the same time interval and record the same parameters. At the end of the second testing, a short feedback will be provided on the BLS/AED competence and further practice will be provided to the students to improve their CPR competence. From this point forward no further data will be collected.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bern, Switzerland, 3010
        • University Hospital Inselspital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First year medical students at the University of Bern participating in the course "Erweiterte Erste Hilfe für Studierende der Humanmedizin" with written informed consent.

Exclusion Criteria:

  • Students with professional BLS-experience, unable to perform BLS, or missing informed consent will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Instructor-led learning
This group will train their technical CPR-skills with supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
Experimental: Self-learning
This group will Train alone without supervision and without communicating with the other participants.
Training without supervision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Correct Compressions
Time Frame: after first BLS course and 3 months later
The percentage of correct compressions obtained from the printed report from the Laerdal Skill Reporter.
after first BLS course and 3 months later

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the Participants BLS Competences After Test
Time Frame: after first BLS course and 3 months later

Assessment of the participant's BLS competence by the study team after test.

Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better.

after first BLS course and 3 months later
Self-assessment of the Participants BLS Competences Before Test
Time Frame: before first BLS course and 3 months later
The participants assessment of their own BLS competences. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely incompetent, no idea what to do, and 100mm = totally competent, cannot be done better.
before first BLS course and 3 months later
Assessment of the Teaching Method
Time Frame: after first BLS course
The participants assessment of the teaching method. Rated on a Visual Analogue Scale from 0-100mm, where 0mm = completely inefficient, and 100mm = totally efficient, nothing can be done better."
after first BLS course
Average Ventilation Volume
Time Frame: after first BLS course and 3 months later
Ventilation volume from the printed report from the Laerdal Skill Reporter (LSR)
after first BLS course and 3 months later
Number of Ventilations Per Minute
Time Frame: after first BLS course and 3 months later
Number of ventilations per minute from the printed report from the Laerdal Skill Reporter (LSR)
after first BLS course and 3 months later
Percentage of Correct Ventilations
Time Frame: after first BLS course and 3 months later
Percentage of correct ventilations from the printed report from the Laerdal Skill Reporter (LSR)
after first BLS course and 3 months later
Number of Participants Using Correct Ratio of Compressions:Ventilations
Time Frame: after first BLS course and 3 months later
the relationship between ventilations and compressions from the printed report from the Laerdal Skill Reporter (LSR). Ventilations - relationship 30 compressions and 2 ventilations.
after first BLS course and 3 months later
Compression Depth
Time Frame: after first BLS course and 3 months later
Compression depth from the printed report from the Laerdal Skill Reporter (LSR)
after first BLS course and 3 months later
Number of Compressions Per Minute
Time Frame: after first BLS course and 3 months later
Number of compressions per minute from the Laerdal Skill Reporter (LSR)
after first BLS course and 3 months later
Compression Frequency
Time Frame: after first BLS course and 3 months later
Compression frequency from the Laerdal Skill Reporter (LSR). Compressions per minute ventilation break included.
after first BLS course and 3 months later
Compressions Too Shallow
Time Frame: after first BLS course and 3 months later
Total percentage of Compressions too shallow from the Laerdal Skill Reporter (LSR)
after first BLS course and 3 months later
False Hand Placement During Compressions
Time Frame: after first BLS course and 3 months later
False hand placement during compressions.
after first BLS course and 3 months later
Incomplete Decompression
Time Frame: after first BLS course and 3 months later
Incomplete decompression from the Laerdal Skill Reporter (LSR)
after first BLS course and 3 months later
Time From Start of Test Till Call for Help
Time Frame: after first BLS course and 3 months later
Time measured from the beginning of the test until the participant calls for help.
after first BLS course and 3 months later
Time From Start of Test Till First Compression
Time Frame: after first BLS course and 3 months later
Time measured from the beginning of the test until the participant makes the first compression.
after first BLS course and 3 months later
Time From Start of Test Till First Ventilation
Time Frame: after first BLS course and 3 months later
Time measured from the beginning of the test until the participant makes the first ventilation.
after first BLS course and 3 months later
Time From Start of Test Till First Shock
Time Frame: after first BLS course and 3 months later
Time measured from the beginning of the test until the participant gives the first shock.
after first BLS course and 3 months later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Robert Greif, MD, University Hospital Bern Inselspital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2017

Primary Completion (Actual)

March 2, 2017

Study Completion (Actual)

July 7, 2017

Study Registration Dates

First Submitted

February 9, 2017

First Submitted That Met QC Criteria

May 2, 2017

First Posted (Actual)

May 5, 2017

Study Record Updates

Last Update Posted (Actual)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 7, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • Req-2016-00071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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