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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Brazil
Information provided by (Responsible Party):
Hospital do Coracao
ClinicalTrials.gov Identifier:
NCT00958958
First received: August 13, 2009
Last updated: February 25, 2012
Last verified: February 2012
  Purpose

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 Intervention
Acute Coronary Syndrome
Other: multifaceted strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Official Title: Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes

Further study details as provided by Hospital do Coracao:

Primary Outcome Measures:
  • Phase 1: patient who've received interventions based on evidence proportion informed by the indicators [ Time Frame: 9 months ] [ Designated as safety issue: No ]
  • Phase 2: increase of prescription of evidence based treatment in clinical practice [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Total mortality and major cardiovascular events [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment: 1150
Study Start Date: January 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Hospital do Coracao

Additional 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
Study First Received: August 13, 2009
Last Updated: February 25, 2012
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014