Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes

NCT ID: NCT00958958

Last Updated: 2012-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-02-29

Brief Summary

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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.

Detailed Description

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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

1. Distribution of educational materials
2. Case manager: Use of a trained person who works in the hospital and will be responsible to assure that all interventions were used
3. Reminders: specific information that is designed or intended to prompt a health professional to recall information (patient bracelets, labels, posters, pocket cards, checklists).
4. 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

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Quality improvement program

There are multifaceted Interventions for the clinic hospital team Including

1. Distribution of educational materials
2. Case manager
3. Reminders
4. Practical training

Group Type OTHER

multifaceted strategy

Intervention Type OTHER

There are multifaceted Interventions Including

1. Distribution of educational materials: distribution of published or printed recommendations for clinical care.
2. Case manager: Use of a trained person who works in the hospital and will be responsible to assure that all interventions were used
3. Reminders
4. Practical training

Hospital standard treatment

Hospital standard treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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multifaceted strategy

There are multifaceted Interventions Including

1. Distribution of educational materials: distribution of published or printed recommendations for clinical care.
2. Case manager: Use of a trained person who works in the hospital and will be responsible to assure that all interventions were used
3. Reminders
4. Practical training

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health, Brazil

OTHER_GOV

Sponsor Role collaborator

Hospital do Coracao

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Otávio Berwanger, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Coracao

Locations

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Hospital do Coração

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 22665103 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22424001 (View on PubMed)

Other Identifiers

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IEP012009

Identifier Type: -

Identifier Source: org_study_id

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