Clinical trial NCT00958958: Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes
Official title: Brazilian Intervention to Increase Evidence Usage in Practice - Acute Coronary Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
randomized cluster trial
quality improvement
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2009-08-14
Enrollment: 1150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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).

Primary outcomes:
measure: Phase 1: patient who've received interventions based on evidence proportion informed by the indicators
timeFrame: 9 months
measure: Phase 2: increase of prescription of evidence based treatment in clinical practice
timeFrame: 6 months
Secondary outcomes:
measure: Total mortality and major cardiovascular events
timeFrame: 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital do Coração
state: SP
Study officials:
affiliation: Hospital do Coracao
name: Otávio Berwanger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.