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

February 25, 2012 updated by: Hospital do Coracao

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

1150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 04005-000
        • Hospital do Coração

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Other: 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
No Intervention: Hospital standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Phase 1: patient who've received interventions based on evidence proportion informed by the indicators
Time Frame: 9 months
9 months
Phase 2: increase of prescription of evidence based treatment in clinical practice
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Total mortality and major cardiovascular events
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital do Coracao

Collaborators

Ministry of Health, Brazil

Investigators

  • Principal Investigator: Otávio Berwanger, PhD, Hospital do Coração

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

August 13, 2009

First Submitted That Met QC Criteria

August 13, 2009

First Posted (Estimate)

August 14, 2009

Study Record Updates

Last Update Posted (Estimate)

February 28, 2012

Last Update Submitted That Met QC Criteria

February 25, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEP012009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Coronary Syndrome

Clinical Trials on multifaceted strategy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe