NCT02664779

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 1, 2021

Status Verified

May 1, 2021

Enrollment Period

1 year

First QC Date

January 22, 2016

Last Update Submit

May 26, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    15 minutes after delivered the intervention

Secondary Outcomes (1)

  • change in the average scores in the groups

    15 minutes after delivered the intervention

Study Arms (3)

Arrhythmia diagnosis with the 10 steps method

EXPERIMENTAL

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.

Other: Arrhythmia diagnosis with the 10 steps method

Arrhythmia diagnosis with the 6 steps method

ACTIVE COMPARATOR

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

Other: Arrhythmia diagnosis with the 6 steps method

Arrhythmia diagnosis with the 4 steps method

ACTIVE COMPARATOR

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

Other: Arrhythmia diagnosis with the 4 steps method

Interventions

Arrhythmia diagnosis with the 10 steps method
Arrhythmia diagnosis with the 6 steps method
Arrhythmia diagnosis with the 4 steps method

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cruz Roja Colombiana

Cali, Valle del Cauca Department, Colombia

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 27, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2017

Study Completion

June 1, 2017

Last Updated

June 1, 2021

Record last verified: 2021-05

Locations