NCT00958958

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

February 28, 2012

Status Verified

February 1, 2012

Enrollment Period

2.1 years

First QC Date

August 13, 2009

Last Update Submit

February 25, 2012

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndromerandomized cluster trialquality improvement

Outcome Measures

Primary Outcomes (2)

  • Phase 1: patient who've received interventions based on evidence proportion informed by the indicators

    9 months

  • Phase 2: increase of prescription of evidence based treatment in clinical practice

    6 months

Secondary Outcomes (1)

  • Total mortality and major cardiovascular events

    6 months

Study Arms (2)

Quality improvement program

OTHER

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

Hospital standard treatment

NO INTERVENTION

Hospital standard treatment

Interventions

multifaceted strategyOTHER

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

Quality improvement program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with thoracic pain who the emergency department physician suspects of ACS and plans start a treatment for this issue

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital do Coração

São Paulo, São Paulo, 04005-000, Brazil

Location

Related Publications (2)

  • 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.

    PMID: 22665103DERIVED

  • 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.

    PMID: 22424001DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Otávio Berwanger, PhD

    Hospital do Coracao

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

January 1, 2010

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

February 28, 2012

Record last verified: 2012-02

Locations

BR(1)