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  • 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

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Cardiovascular medicine
Protocol
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
  1. Colin C Everett1,
  2. Keith AA Fox2,
  3. Catherine Reynolds1,
  4. Catherine Fernandez1,
  5. Linda Sharples3,
  6. Deborah D Stocken1,
  7. Kathryn Carruthers4,
  8. Harry Hemingway5,6,7,
  9. Andrew T Yan8,
  10. Shaun G Goodman8,
  11. David Brieger9,
  12. Derek P Chew10,
  13. Chris P Gale11
  1. 1 Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK
  2. 2 Royal Infirmary of Edinburgh, Edinburgh, UK
  3. 3 Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK
  4. 4 Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, UK
  5. 5 Health Data Research UK London, UCL, London, UK
  6. 6 Institute of Health Informatics, UCL, London, UK
  7. 7 The National Institute for Health Research UCL Hospitals Biomedical Research Centre, UCL, London, UK
  8. 8 St. Michael’s Hospital, Toronto, Canada
  9. 9 The University of Sydney, Sydney, Australia
  10. 10 Department of Cardiovascular Medicine, Flinders Medical Centre, Bedford Park, South Australia, Australia
  11. 11 Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds, UK
  1. Correspondence to Prof. Chris P Gale; c.p.gale{at}leeds.ac.uk

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.

  • acute coronary syndrome
  • nsteacs
  • cluster randomised trial
  • guideline-indicated treatment
  • risk stratification
  • grace

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2019-032165

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    Footnotes

    • Twitter @cpgale3

    • Contributors UKGRIS study design and conception: CPG, KAAF, HH, LS, DDS, DB, KC, ATY, DPC. Writing of the manuscript: CCE, KAAF, LS, CR, CF, DDS, KC, HH, DB, ATY SGG, DPC, CPG. All authors have read and approve of the final manuscript.

    • Funding UKGRIS is funded by the British Heart Foundation (BHF Grant reference: CS/16/2/32145). Neither the funder nor the study sponsor (the University of Leeds) have any role any of the following activities: collection, analysis or interpretation of data; writing of the study report and decisions as to whether and when to publish the findings of this trial. In all cases, decisions rest with the authors. The funder reviewed the study design as a condition of awarding funds, but had no further role in the study design. All publications for UKGRIS must comply with the BHF’s policy on Open Access Publication, as a condition of the study grant. HH is a National Institute for Health Research (NIHR) Senior Investigator (grant NF-SI0616-10066) and is funded by awards from the Medical Research Council, Arthritis Research UK, British Heart Foundation, Cancer Research UK, Chief Scientist Office, Economic and Social Research Council, Engineering and Physical Sciences Research Council, NIHR, National Institute for Social Care and Health Research, and Wellcome Trust (grant MR/K006584/1).

    • Competing interests None declared.

    • Ethics approval North East - Tyne & Wear South Research Ethics Committee. 31st October, 2016 (reference 14/NE/1180).

    • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

    • Presented at This protocol has been presented in abstract form at the 2018 Methods for Evaluation of medical prediction Models, Tests And Biomarkers meeting in Utrecht, Netherlands, 1st-3rd July 2018.

    • Patient consent for publication Not required.