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)

• Published in: The American heart journal Vol. 170; no. 5; pp. 995 - 1004.e1
• Main Authors: Chew, Derek P., MBBS, MPH, Astley, Carolyn M., RN, DrPH, Luker, Heather, MPH, Alprandi-Costa, Bernadette, RN, Hillis, Graham, MBBS, PhD, Chow, Clara K., MBBS, PhD, Quinn, Steve, PhD, Yan, Andrew T., MD, Gale, Chris P., PhD, Goodman, Shaun, MD, Fox, Keith A.A., MBBS, Brieger, David, MBBS, PhD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.11.2015; Elsevier Limited
• Subjects: Acute Coronary Syndrome - therapy; Acute coronary syndromes; Aged; Angina pectoris; Australia; Cardiovascular; Decision making; Disease Management; Female; Heart attacks; Humans; Male; Prospective Studies; Registries - statistics & numerical data; Risk Assessment - methods; Risk Factors; Australia
• ISSN: 0002-8703; 1097-6744
• DOI: 10.1016/j.ahj.2015.07.032

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. Design 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. Summary The AGRIS trial will establish the effect of routine objective risk stratification using the GRACE risk score on ACS care and clinical outcomes.