The Australian Grace Risk score Intervention study (AGRIS): a hospital level cluster randomised clinical trial with blinded endpoint evaluation which aims to enhance evidence based decision making and outcome delivery of Australian Acute Coronary Syndrome (ACS) care by evaluating a GRACE Risk score based decision support tool versus standard care

The Australian GRACE Risk Intervention Study is assessing risk stratification in acute coronary syndrome patients using the Grace Risk Score and treatment recommendation tool (GRS) versus standard patient care. The Grace Risk tool includes calculation of ischaemic and bleeding risk scores, a nomogram to assess patient risk / benefit, a treatment recommendation plan (based on guideline recommended investigations and therapies) and documentation of physician intended therapies. Based on the risk scores, patients are categorized into low, intermediate or high risk of ACS and bleeding and physicians are directed to recommended investigations and treatments according to the level of risk. This paper based tool is completed and placed into the patient's medical records early in the patient assessment process. It is then reviewed by the treating physician to acknowledge that the recommendations have been considered. Following a 3 month implementation period where hospital staff are trained on use of the tool, patients will commence entry into the study. Post implementation, sites will be followed up to confirm continued use of the tool. A clinical champion will be identified at each site to assist in implementation of the tool. A copy of the completed patient GRS will be submitted to the coordinating group. Each site will enrol 80 patients (approximately 10 patients per month). The duration of the intervention period will therefore be 12-18 months according to patient recruitment. This study will also employ a Data Safety Monitoring Committee to evaluate blinded study endpoints in each of the 2 groups.