Variation Between Hospitals in Short-term Mortality After Acute Coronary Syndromes: A CALIBER Study

Sponsor
University College, London (Other)
Overall Status
Completed
CT.gov ID
NCT01111071
Collaborator
Barts & The London NHS Trust (Other), Queen Mary University of London (Other), University of Bristol (Other), Yale University (Other)
316,648
1
56
5652.8

Study Details

Study Description

Brief Summary

We seek to investigate whether hospitals in England and Wales vary in their rate of mortality following admission for heart attack or unstable angina, the extent of such variation, whether discharge diagnosis affects the extent of variation, and whether such variation has changed over time. Furthermore, we will investigate what individual- or hospital-level factors explain variation in mortality between hospitals.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Several studies have looked at between-hospital variation in mortality following myocardial infarction but have lacked patient-level data. Those with individual-level data have been limited by:

    • use of in-hospital mortality as an outcome measure, which can be affected by length of stay,

    • restriction to patients aged 65 and over, or otherwise selected patients, and

    • patient-level explanatory factors lacking clinical detail, particularly medications given in hospital.

    MINAP patient-level data allow the investigation of hospital variation in mortality (in-hospital and 30-day) in a group of unselected patients, taking into account clinical details such as medication use in hospital, as well as features of the hospitals providing care. The proposed study will establish the extent of variation between hospitals in England and Wales, whether this varies by ACS diagnosis, whether the variation has reduced over time and finally which patient-level or hospital-level factors explain any variation found.

    A statistical analytic protocol for this study, dated 15.4.2010, is available on request.

    This study is part of the CALIBER (Cardiovascular disease research using linked bespoke studies and electronic records) programme funded over 5 years from the NIHR and Wellcome Trust. The central theme of the CALIBER research is linkage of the Myocardial Ischaemia National Audit Project (MINAP) with primary care (GPRD) and other resources. The overarching aim of CALIBER is to better understand the aetiology and prognosis of specific coronary phenotypes across a range of causal domains, particularly where electronic records provide a contribution beyond traditional studies. CALIBER has received both Ethics approval (ref 09/H0810/16) and ECC approval (ref ECC 2-06(b)/2009 CALIBER dataset).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    316648 participants
    Time Perspective:
    Prospective
    Official Title:
    Variation Between Hospitals in Short-term Mortality After Acute Coronary Syndromes: A CALIBER Study
    Study Start Date :
    Apr 1, 2010
    Actual Primary Completion Date :
    Sep 1, 2014
    Actual Study Completion Date :
    Dec 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    STEMI

    patients with discharge diagnosis of ST elevation myocardial infarction

    nSTEMI

    patients with discharge diagnosis of non ST elevation myocardial infarction

    unstable angina

    patients with discharge diagnosis of unstable angina

    Outcome Measures

    Primary Outcome Measures

    1. all-cause 30-day mortality [30 day]

      all-cause 30-day mortality following hospitalisation for acute coronary syndrome

    Secondary Outcome Measures

    1. all-cause in-hospital mortality [length of hospital stay]

      all-cause in-hospital mortality following hospitalisation for acute coronary syndrome

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • admitted between January 2003 to June 2009 (or latest date data available)
    Exclusion Criteria:
    • admitted to hospital with fewer than 25 admissions in given year

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Epidemiology and Public Health, University College London London United Kingdom WC1E 6BT

    Sponsors and Collaborators

    • University College, London
    • Barts & The London NHS Trust
    • Queen Mary University of London
    • University of Bristol
    • Yale University

    Investigators

    • Principal Investigator: Julie L George, MSc, University College, London

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Julie George, NIHR Doctoral Fellow, University College, London
    ClinicalTrials.gov Identifier:
    NCT01111071
    Other Study ID Numbers:
    • CALIBER-09-03
    • RP-PG-0407-10314
    First Posted:
    Apr 27, 2010
    Last Update Posted:
    May 12, 2016
    Last Verified:
    May 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Julie George, NIHR Doctoral Fellow, University College, London
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 12, 2016