title: A cluster randomized trial of objective risk assessment versus standard care for acute coronary syndromes: Rationale and design of the Australian GRACE Risk score Intervention Study (AGRIS).
abstract: BACKGROUND
  Assessing risk and weighing the potential benefits from evidence-based therapies are essential in the clinical decision making process of optimizing care and outcomes for patients presenting with acute coronary syndromes (ACS). Such practices are advocated in international clinical guidelines of ACS care. While the GRACE risk score (GRS) is a guideline advocated, well-validated risk stratification tool, its utility in improving care and outcomes remains unproven, and its application has been limited in routine clinical practice.
  
  
  OBJECTIVE
  This study will assess the effectiveness using the GRS tool and treatment recommendations during patient assessment on improving the application of guideline-recommended therapies in ACS care.
  
  
  METHODS
  This study employs a PROBE (prospective cluster [hospital-level] randomized open-label, blinded endpoint) design to evaluate objective measures of hospital performance, with clinical events adjudicated by a blinded event committee. This randomized study is nested within the established CONCORDANCE registry of ACS patients, with existing methods for data collection and monitoring of care and clinical outcomes. The hospital-level intervention is the integration of the GRS into routine ACS patient assessment process. The study will assess the use of early invasive management, prescription of guideline recommended pharmacology and referral to cardiac rehabilitation by hospital discharge; with the key composite clinical endpoint of cardiovascular death, new or recurrent myocardial infarction, in-hospital heart failure or cardiovascular readmission at 12 months. Health economic impacts of risk stratification implementation will also be evaluated. The study will recruit 3000 patients from 30 hospitals.
  
  
  CONCLUSIONS
  The AGRIS trial will establish the effect of routine objective risk stratification using the GRACE risk score on ACS care and clinical outcomes.
authors.affiliation: School of Medicine, Flinders University of South Australia, Adelaide, Australia.
authors.forename: Derek P
authors.initials: DP
authors.lastname: Chew
authors.affiliation: School of Medicine, Flinders University of South Australia, Adelaide, Australia; South Australian Department of Health/Flinders University, Adelaide, Australia.
authors.forename: Carolyn M
authors.initials: CM
authors.lastname: Astley
authors.affiliation: Concord Hospital, University of Sydney, Sydney, Australia.
authors.forename: Heather
authors.initials: H
authors.lastname: Luker
authors.affiliation: Concord Hospital, University of Sydney, Sydney, Australia.
authors.forename: Bernadette
authors.initials: B
authors.lastname: Alprandi-Costa
authors.affiliation: School of Medicine, University of Western Australia, Perth, Australia.
authors.forename: Graham
authors.initials: G
authors.lastname: Hillis
authors.affiliation: The George Institute for Global Health, University of Sydney and Westmead Hospital, Sydney, Australia; Division of Cardiology, Department of Medicine, St. Michael's Hospital, Toronto, Ontario, Canada.
authors.forename: Clara K
authors.initials: CK
authors.lastname: Chow
authors.affiliation: School of Medicine, Flinders University of South Australia, Adelaide, Australia.
authors.forename: Steve
authors.initials: S
authors.lastname: Quinn
authors.affiliation: Heart & Stroke Foundation of Ontario, Department of Medicine, University of Toronto, Toronto, Canada.
authors.forename: Andrew T
authors.initials: AT
authors.lastname: Yan
authors.affiliation: Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK.
authors.forename: Chris P
authors.initials: CP
authors.lastname: Gale
authors.affiliation: Heart & Stroke Foundation of Ontario, Department of Medicine, University of Toronto, Toronto, Canada.
authors.forename: Shaun
authors.initials: S
authors.lastname: Goodman
authors.affiliation: University of Edinburgh, Edinburgh, UK.
authors.forename: Keith A A
authors.initials: KA
authors.lastname: Fox
authors.affiliation: Concord Hospital, University of Sydney, Sydney, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Brieger
mesh_terms: D054058:Acute Coronary Syndrome / Q000628:therapy*; D000368:Aged; D001315:Australia; D019468:Disease Management; D005260:Female; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012042:Registries / Q000706:statistics & numerical data*; D018570:Risk Assessment / Q000379:methods*; D012307:Risk Factors