- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02664779
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.
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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Valle Del Cauca
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Cali, Valle Del Cauca, Colombie
- Cruz Roja Colombiana
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: Arrhythmia diagnosis with the 10 steps method
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.
|
|
Comparateur actif: Arrhythmia diagnosis with the 6 steps method
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
|
|
Comparateur actif: Arrhythmia diagnosis with the 4 steps method
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
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
percentage of subjects who achieve scores greater than or equal to 30
Délai: 15 minutes after delivered the intervention
|
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.
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15 minutes after delivered the intervention
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
change in the average scores in the groups
Délai: 15 minutes after delivered the intervention
|
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.
|
15 minutes after delivered the intervention
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- ALS1
Informations sur les médicaments et les dispositifs, documents d'étude
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