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Determination and Comparison of Short-term Effectiveness of Three Methods Used for Recognition of Arrhythmias in People With Different Degrees of Medical Training (Advanced Life Support Workshop Participants-ALS): Randomized Controlled Educational Experiment.

Primary Purpose

Arrhythmias

Status
Completed
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Arrhythmia diagnosis with the 10 steps method
Arrhythmia diagnosis with the 6 steps method
Arrhythmia diagnosis with the 4 steps method
Sponsored by
Universidad Nacional de Colombia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arrhythmias

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • • Health professionals

    • Attend a course in Advanced Life Support in Cali (Colombia), during the study period.
    • Voluntarily accept to participate in the study

Exclusion Criteria:

  • No

Sites / Locations

  • Cruz Roja Colombiana

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Arrhythmia diagnosis with the 10 steps method

Arrhythmia diagnosis with the 6 steps method

Arrhythmia diagnosis with the 4 steps method

Arm Description

Of participants whom attending the workshop, we will take 84 whom agree to participate and sign the informed consent. They will be divided into subgroups according to their degree of medical training (nursing technicians, university nursing students, university medical students, nurse practitioners graduates, Professional medical graduates, residents of medical specialties and specialists) and randomly assigned one by one from each educational subgroup to 3 intervention groups A, B or C (A = 10 STEPS method, B = 6 STEPS method, C = 4 STEPS method ) so that each group has the third participants of each level of education ensuring matched groups on the level of training of participants in each group. Following this, an equal theoretical test will be performed for all groups to determine the knowledge base in arrhythmias.

Of participants whom attending the workshop, we will take 84 whom agree to participate and sign the informed consent. They will be divided into subgroups according to their degree of medical training (nursing technicians, university nursing students, university medical students, nurse practitioners graduates, Professional medical graduates, residents of medical specialties and specialists) and randomly assigned one by one from each educational subgroup to 3 intervention groups A, B or C (A = 10 STEPS method, B = 6 STEPS method, C = 4 STEPS method ) so that each group has the third participants of each level of education ensuring matched groups on the level of training of participants in each group. Following this, an equal theoretical test will be performed for all groups to determine the knowledge base in arrhythmias

Of participants whom attending the workshop, we will take 84 whom agree to participate and sign the informed consent. They will be divided into subgroups according to their degree of medical training (nursing technicians, university nursing students, university medical students, nurse practitioners graduates, Professional medical graduates, residents of medical specialties and specialists) and randomly assigned one by one from each educational subgroup to 3 intervention groups A, B or C (A = 10 STEPS method, B = 6 STEPS method, C = 4 STEPS method ) so that each group has the third participants of each level of education ensuring matched groups on the level of training of participants in each group. Following this, an equal theoretical test will be performed for all groups to determine the knowledge base in arrhythmias

Outcomes

Primary Outcome Measures

percentage of subjects who achieve scores greater than or equal to 30
For comparison of the percentage of subjects who achieve scores greater than or equal to 30 (approving minimum score) in the practical test of arrhythmia's diagnosis, the test will be the Chi-square (X2), which allows to compare proportions in more than two groups; or Fisher's exact test, submitted that one of the expected values is less than 5.

Secondary Outcome Measures

change in the average scores in the groups
In order to compare the magnitude of the change in the average scores in the groups trained with each of the 3 methods, both in the the theoretical and practical test of diagnosis of arrhythmias; ANOVA or Mann-Whitney's U, according to the distribution of variables was performed. These comparisons are made to the post intervention measurements and Bonferroni correction for alpha according to the number of comparisons will perform. The analysis of the collected data will be using STATA 10.0 software.

Full Information

First Posted
January 22, 2016
Last Updated
May 26, 2021
Sponsor
Universidad Nacional de Colombia
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1. Study Identification

Unique Protocol Identification Number
NCT02664779
Brief Title
Determination and Comparison of Short-term Effectiveness of Three Methods Used for Recognition of Arrhythmias in People With Different Degrees of Medical Training (Advanced Life Support Workshop Participants-ALS): Randomized Controlled Educational Experiment.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad Nacional de Colombia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Background: Arrhythmia recognition is a fundamental skill for the provider of advanced life support (ALS). Acquire it is difficult, leading to the birth of systematic methods in an attempt to simplify and optimize, however, it has not compared the effectiveness among the three methods with more evidence among professionals with varying degrees of medical training (ALS Workshop participants). Objective: To determine and compare the effectiveness of the three most widespread and with more evidence systematic methods (10, 6 and 4 steps) for the recognition of arrhythmias in a short-term and its perceived easiness among ALS workshop participants. Methods / design: Educational Cuasi experimental trial with pre and post intervention measurement, blind, with randomized allocation, in 84 ALS workshop participants. Three systematic methods to recognize arrhythmias will be taught and their effectiveness to diagnose in a short-term and its perceived easiness will be measured and compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arrhythmia diagnosis with the 10 steps method
Arm Type
Experimental
Arm Description
Of participants whom attending the workshop, we will take 84 whom agree to participate and sign the informed consent. They will be divided into subgroups according to their degree of medical training (nursing technicians, university nursing students, university medical students, nurse practitioners graduates, Professional medical graduates, residents of medical specialties and specialists) and randomly assigned one by one from each educational subgroup to 3 intervention groups A, B or C (A = 10 STEPS method, B = 6 STEPS method, C = 4 STEPS method ) so that each group has the third participants of each level of education ensuring matched groups on the level of training of participants in each group. Following this, an equal theoretical test will be performed for all groups to determine the knowledge base in arrhythmias.
Arm Title
Arrhythmia diagnosis with the 6 steps method
Arm Type
Active Comparator
Arm Description
Of participants whom attending the workshop, we will take 84 whom agree to participate and sign the informed consent. They will be divided into subgroups according to their degree of medical training (nursing technicians, university nursing students, university medical students, nurse practitioners graduates, Professional medical graduates, residents of medical specialties and specialists) and randomly assigned one by one from each educational subgroup to 3 intervention groups A, B or C (A = 10 STEPS method, B = 6 STEPS method, C = 4 STEPS method ) so that each group has the third participants of each level of education ensuring matched groups on the level of training of participants in each group. Following this, an equal theoretical test will be performed for all groups to determine the knowledge base in arrhythmias
Arm Title
Arrhythmia diagnosis with the 4 steps method
Arm Type
Active Comparator
Arm Description
Of participants whom attending the workshop, we will take 84 whom agree to participate and sign the informed consent. They will be divided into subgroups according to their degree of medical training (nursing technicians, university nursing students, university medical students, nurse practitioners graduates, Professional medical graduates, residents of medical specialties and specialists) and randomly assigned one by one from each educational subgroup to 3 intervention groups A, B or C (A = 10 STEPS method, B = 6 STEPS method, C = 4 STEPS method ) so that each group has the third participants of each level of education ensuring matched groups on the level of training of participants in each group. Following this, an equal theoretical test will be performed for all groups to determine the knowledge base in arrhythmias
Intervention Type
Other
Intervention Name(s)
Arrhythmia diagnosis with the 10 steps method
Intervention Type
Other
Intervention Name(s)
Arrhythmia diagnosis with the 6 steps method
Intervention Type
Other
Intervention Name(s)
Arrhythmia diagnosis with the 4 steps method
Primary Outcome Measure Information:
Title
percentage of subjects who achieve scores greater than or equal to 30
Description
For comparison of the percentage of subjects who achieve scores greater than or equal to 30 (approving minimum score) in the practical test of arrhythmia's diagnosis, the test will be the Chi-square (X2), which allows to compare proportions in more than two groups; or Fisher's exact test, submitted that one of the expected values is less than 5.
Time Frame
15 minutes after delivered the intervention
Secondary Outcome Measure Information:
Title
change in the average scores in the groups
Description
In order to compare the magnitude of the change in the average scores in the groups trained with each of the 3 methods, both in the the theoretical and practical test of diagnosis of arrhythmias; ANOVA or Mann-Whitney's U, according to the distribution of variables was performed. These comparisons are made to the post intervention measurements and Bonferroni correction for alpha according to the number of comparisons will perform. The analysis of the collected data will be using STATA 10.0 software.
Time Frame
15 minutes after delivered the intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: • Health professionals Attend a course in Advanced Life Support in Cali (Colombia), during the study period. Voluntarily accept to participate in the study Exclusion Criteria: No
Facility Information:
Facility Name
Cruz Roja Colombiana
City
Cali
State/Province
Valle Del Cauca
Country
Colombia

12. IPD Sharing Statement

Learn more about this trial

Determination and Comparison of Short-term Effectiveness of Three Methods Used for Recognition of Arrhythmias in People With Different Degrees of Medical Training (Advanced Life Support Workshop Participants-ALS): Randomized Controlled Educational Experiment.

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