Evaluation of the impact of the GRACE risk score on the management and outcome of patients hospitalised with non-ST elevation acute coronary syndrome in the UK: protocol of the UKGRIS cluster-randomised registry-based trial

Abstract

Introduction: For non-ST-segment elevation acute coronary syndrome (NSTEACS) there is a gap between the use of class I guideline recommended therapies and clinical practice. The Global Registry of Acute Coronary Events (GRACE) risk score is recommended in international guidelines for the risk stratification of NSTEACS, but its impact on adherence to guideline-indicated treatments and reducing adverse clinical outcomes is unknown. The objective of the UK GRACE Risk Score Intervention Study (UKGRIS) trial is to assess the effectiveness of the GRACE risk score tool and associated treatment recommendations on the use of guideline-indicated care and clinical outcomes.

Methods and analysis: The UKGRIS, a parallel-group cluster randomised registry-based controlled trial, will allocate hospitals in a 1:1 ratio to manage NSTEACS by standard care or according to the GRACE risk score and associated international guidelines. UKGRIS will recruit a minimum of 3000 patients from at least 30 English National Health Service hospitals and collect healthcare data from national electronic health records. The co-primary endpoints are the use of guideline-indicated therapies, and the composite of cardiovascular death, non-fatal myocardial infarction, new onset heart failure hospitalisation or cardiovascular readmission at 12 months. Secondary endpoints include duration of inpatient hospital stay over 12 months, EQ-5D-5L responses and utilities, unscheduled revascularisation and the components of the composite endpoint over 12 months follow-up.

Ethics and dissemination: The study has ethical approval (North East - Tyne & Wear South Research Ethics Committee reference: 14/NE/1180). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the funder's open access policy.

Trial registration number: ISRCTN29731761; Pre-results.

Keywords: acute coronary syndrome; cluster randomised trial; grace; guideline-indicated treatment; nsteacs; risk stratification.

Figure 1

GRACE site recruitment and study run-in. CTRU, Leeds Clinical Trials Research Unit; GRACE, Global Registry of Acute Coronary Events.

Figure 2

GRACE and CRUSADE risk scoring paper chart (completed by intervention sites only, and not distributed to control arm sites). CRUSADE, Can Rapid risk stratification of Unstable angina patients Suppress ADverse outcomes with Early implementation of the ACC/AHA Guidelines; CTRU, Leeds Clinical Trials Research Unit; eGFR, estimated glomerular filtration rate; GRACE, Global Registry of Acute Coronary Events; Hct, haematocrit; SBP, systolic blood pressure; UKGRIS, UK GRACE Risk Score Intervention Study.

Figure 3

Associated guideline recommended therapies for GRACE risk score categories (completed by intervention sites only, not distributed to control arm sites). ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; CTRU, Leeds Clinical Trials Research Unit; GRACE, Global Registry of Acute Coronary Events; LV, left ventricular; MI, myocardial infarction; NICE, National Institute for Health and Care Excellence; NSTEACS, non-ST-segment elevation acute coronary syndrome; PCI, percutaneous coronary intervention; STEMI, ST-elevation myocardial infarction; UA, urinalysis; UF, unfractionated; UKGRIS, UK GRACE Risk Score Intervention Study.