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

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ClinicalTrials.gov Identifier: NCT00958958
Recruitment Status : Completed
First Posted : August 14, 2009
Last Update Posted : February 28, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Acute Coronary Syndrome Other: multifaceted strategy

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Official Title: Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes
Study Start Date : January 2010
Primary Completion Date : February 2012
Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Hospital standard treatment


Outcome Measures

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

Secondary Outcome Measures :
  1. Total mortality and major cardiovascular events [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00958958


Locations
Brazil
Hospital do Coração
São Paulo, SP, Brazil, 04005-000
Sponsors and Collaborators
Hospital do Coracao
Ministry of Health, Brazil
Investigators
Principal Investigator: Otávio Berwanger, PhD Hospital do Coracao
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT00958958     History of Changes
Other Study ID Numbers: IEP012009
First Posted: August 14, 2009    Key Record Dates
Last Update Posted: February 28, 2012
Last Verified: February 2012

Keywords provided by Hospital do Coracao:
Acute Coronary Syndrome
randomized cluster trial
quality improvement

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases