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

Acute Coronary Syndrome Clinical Trial

— BRIDGE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958958
• Other study ID #: IEP012009
• Status: Completed
• Phase: N/A
• First received: August 13, 2009
• Last updated: February 25, 2012
• Start date: January 2010
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1150
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Intervention

Other:
• multifaceted strategy
There are multifaceted Interventions Including Distribution of educational materials: distribution of published or printed recommendations for clinical care. Case manager: Use of a trained person who works in the hospital and will be responsible to assure that all interventions were used Reminders Practical training

Locations

Country	Name	City	State
Brazil	Hospital do Coração	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital do Coracao	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1: patient who've received interventions based on evidence proportion informed by the indicators		9 months	No
Primary	Phase 2: increase of prescription of evidence based treatment in clinical practice		6 months	No
Secondary	Total mortality and major cardiovascular events		6 months	No