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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01111071

First Posted: April 27, 2010

Last Update Posted: May 12, 2016

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Barts & The London NHS Trust

Queen Mary University of London

University of Bristol

Yale University

Information provided by (Responsible Party):

Julie George, University College, London

Purpose

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
Acute Coronary Syndrome


Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Variation Between Hospitals in Short-term Mortality After Acute Coronary Syndromes: A CALIBER Study

Resource links provided by NLM:

MedlinePlus related topics: Health Facilities

U.S. FDA Resources

Further study details as provided by Julie George, University College, London:

Primary Outcome Measures:

all-cause 30-day mortality [ Time Frame: 30 day ]
all-cause 30-day mortality following hospitalisation for acute coronary syndrome

Secondary Outcome Measures:

all-cause in-hospital mortality [ Time Frame: length of hospital stay ]
all-cause in-hospital mortality following hospitalisation for acute coronary syndrome


Enrollment:	316648
Study Start Date:	April 2010
Study Completion Date:	December 2014
Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

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).

Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	30 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients admitted with acute coronary syndrome to acute hospitals in England and Wales participating in the Myocardial Ischaemia National Audit Project (MINAP)

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111071

Locations


United Kingdom
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

More Information

Additional Information:

CArdiovascular disease research Linking Bespoke studies and Electronic Records This link exits the ClinicalTrials.gov site

Publications:

Bradley EH, Herrin J, Elbel B, McNamara RL, Magid DJ, Nallamothu BK, Wang Y, Normand SL, Spertus JA, Krumholz HM. Hospital quality for acute myocardial infarction: correlation among process measures and relationship with short-term mortality. JAMA. 2006 Jul 5;296(1):72-8.

Heidenreich PA, Lewis WR, LaBresh KA, Schwamm LH, Fonarow GC. Hospital performance recognition with the Get With The Guidelines Program and mortality for acute myocardial infarction and heart failure. Am Heart J. 2009 Oct;158(4):546-53. doi: 10.1016/j.ahj.2009.07.031.

Peterson ED, Roe MT, Mulgund J, DeLong ER, Lytle BL, Brindis RG, Smith SC Jr, Pollack CV Jr, Newby LK, Harrington RA, Gibler WB, Ohman EM. Association between hospital process performance and outcomes among patients with acute coronary syndromes. JAMA. 2006 Apr 26;295(16):1912-20.

Alter DA, Austin PC, Tu JV; Canadian Cardiovascular Outcomes Research Team. Community factors, hospital characteristics and inter-regional outcome variations following acute myocardial infarction in Canada. Can J Cardiol. 2005 Mar;21(3):247-55.

Krumholz HM, Chen J, Wang Y, Radford MJ, Chen YT, Marciniak TA. Comparing AMI mortality among hospitals in patients 65 years of age and older: evaluating methods of risk adjustment. Circulation. 1999 Jun 15;99(23):2986-92.

Krumholz HM, Wang Y, Mattera JA, Wang Y, Han LF, Ingber MJ, Roman S, Normand SL. An administrative claims model suitable for profiling hospital performance based on 30-day mortality rates among patients with an acute myocardial infarction. Circulation. 2006 Apr 4;113(13):1683-92. Epub 2006 Mar 20.

Krumholz HM, Wang Y, Chen J, Drye EE, Spertus JA, Ross JS, Curtis JP, Nallamothu BK, Lichtman JH, Havranek EP, Masoudi FA, Radford MJ, Han LF, Rapp MT, Straube BM, Normand SL. Reduction in acute myocardial infarction mortality in the United States: risk-standardized mortality rates from 1995-2006. JAMA. 2009 Aug 19;302(7):767-73. doi: 10.1001/jama.2009.1178.

Granger CB, Steg PG, Peterson E, López-Sendón J, Van de Werf F, Kline-Rogers E, Allegrone J, Dabbous OH, Klein W, Fox KA, Eagle KA; GRACE Investigators. Medication performance measures and mortality following acute coronary syndromes. Am J Med. 2005 Aug;118(8):858-65.

Rasmussen S, Zwisler AD, Abildstrom SZ, Madsen JK, Madsen M. Hospital variation in mortality after first acute myocardial infarction in Denmark from 1995 to 2002: lower short-term and 1-year mortality in high-volume and specialized hospitals. Med Care. 2005 Oct;43(10):970-8.

Rasmussen S, Abildstrom SZ, Rasmussen JN, Gislason GH, Schramm TK, Folke F, Køber L, Torp-Pedersen C, Madsen M. Hospital variation in use of secondary preventive medicine after discharge for first acute myocardial infarction during 1995-2004. Med Care. 2008 Jan;46(1):70-7.

Rosato S, Seccareccia F, D'Errigo P, Fusco D, Maraschini A, Badoni G, Perucci CA. Thirty-day mortality after AMI: effect modification by gender in outcome studies. Eur J Public Health. 2010 Aug;20(4):397-402. doi: 10.1093/eurpub/ckp194. Epub 2009 Nov 27.

Popescu I, Werner RM, Vaughan-Sarrazin MS, Cram P. Characteristics and outcomes of America's lowest-performing hospitals: an analysis of acute myocardial infarction hospital care in the United States. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):221-7. doi: 10.1161/CIRCOUTCOMES.108.813790. Epub 2009 May 5. Erratum in: Circ Cardiovasc Qual Outcomes. 2011 May 1;4(3):e2.

Kosseim M, Mayo NE, Scott S, Hanley JA, Brophy J, Gagnon B, Pilote L. Ranking hospitals according to acute myocardial infarction mortality: should transfers be included? Med Care. 2006 Jul;44(7):664-70.

Murphy NF, MacIntyre K, Stewart S, Capewell S, McMurray JJ. Reduced between-hospital variation in short term survival after acute myocardial infarction: the result of improved cardiac care? Heart. 2005 Jun;91(6):726-30.

Leyland AH, Boddy FA. League tables and acute myocardial infarction. Lancet. 1998 Feb 21;351(9102):555-8.


Responsible Party:	Julie George, NIHR Doctoral Fellow, University College, London
ClinicalTrials.gov Identifier:	NCT01111071 History of Changes
Other Study ID Numbers:	CALIBER-09-03 RP-PG-0407-10314 ( Other Grant/Funding Number: National Institute of Health Research (UK) )
First Submitted:	April 16, 2010
First Posted:	April 27, 2010
Last Update Posted:	May 12, 2016
Last Verified:	May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	permissions to use anonymised data from data owners do not allow further sharing.

Keywords provided by Julie George, University College, London:


hospital variation 30 day mortality in hospital mortality acute coronary syndrome	myocardial infarction unstable angina hospital performance trends

Additional relevant MeSH terms:


Syndrome Acute Coronary Syndrome Disease Pathologic Processes	Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases

To Top