- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00958958
Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes (BRIDGE)
Phase 1: An observational study (registry) will be conducted which will objectively document the ACS clinical practice in Brazilian public hospitals, and identify the important barriers for the evidence usage incorporation in the clinical practice.
Phase 2: A Cluster randomized clinical trial in which public hospital will be randomized to receive or not a multifaceted strategy in order to increase evidence based therapy in clinical practice.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
STUDY POPULATION:
Patients with thoracic pain who the emergency department physician suspects of ACS and plans start a treatment for this issue; It will be excluded patients transferred of others institutions with 12 hours of symptoms.
PROGRAM:
There are multifaceted Interventions Including
- Distribution of educational materials
- Case manager: Use of a trained person who works in the hospital and will be responsible to assure that all interventions were used
- Reminders: specific information that is designed or intended to prompt a health professional to recall information (patient bracelets, labels, posters, pocket cards, checklists).
- Practical training
ENDPOINTS:
Phase 1 Primary outcome; patient who've received interventions based on evidence proportion informed by the indicators; Phase 2
Primary outcome:
Increase of prescription of evidence based treatment in clinical practice Secondary outcome Total mortality and major cardiovascular events
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
SP
-
São Paulo, SP, Brésil, 04005-000
- Hospital do Coracao
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Patient Eligibility criteria
Inclusion Criteria:
- Patients with thoracic pain who the emergency department physician suspects of ACS and plans start a treatment for this issue
Exclusion Criteria:
- Patients transferred from others institutions within 12 hours of the symptoms
Cluster Eligibility Criteria
- National Public Hospitals with emergency department. A cluster can be one hospital with emergency department, or 2 or more hospitals (for example: 1 emergency hospital and 1 general hospital which receive the patients to perform PCI).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Quality improvement program
There are multifaceted Interventions for the clinic hospital team Including
|
There are multifaceted Interventions Including
|
|
Aucune intervention: Hospital standard treatment
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Phase 1: patient who've received interventions based on evidence proportion informed by the indicators
Délai: 9 months
|
9 months
|
|
Phase 2: increase of prescription of evidence based treatment in clinical practice
Délai: 6 months
|
6 months
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Total mortality and major cardiovascular events
Délai: 6 months
|
6 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Otávio Berwanger, PhD, Hospital do Coracao
Publications et liens utiles
Publications générales
- Berwanger O, Guimaraes HP, Laranjeira LN, Cavalcanti AB, Kodama AA, Zazula AD, Santucci EV, Victor E, Tenuta M, Carvalho V, Mira VL, Pieper KS, Weber B, Mota LH, Peterson ED, Lopes RD; Bridge-Acs Investigators. Effect of a multifaceted intervention on use of evidence-based therapies in patients with acute coronary syndromes in Brazil: the BRIDGE-ACS randomized trial. JAMA. 2012 May 16;307(19):2041-9. doi: 10.1001/jama.2012.413.
- Berwanger O, Guimaraes HP, Laranjeira LN, Cavalcanti AB, Kodama A, Zazula AD, Santucci E, Victor E, Flato UA, Tenuta M, Carvalho V, Mira VL, Pieper KS, Mota LH, Peterson ED, Lopes RD; BRIDGE-ACS. A multifaceted intervention to narrow the evidence-based gap in the treatment of acute coronary syndromes: rationale and design of the Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes (BRIDGE-ACS) cluster-randomized trial. Am Heart J. 2012 Mar;163(3):323-29, 329.e1. doi: 10.1016/j.ahj.2012.02.004.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
- IEP012009
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