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Study of the Effectiveness of Report Cards on the Quality of Care for Heart Attack and Heart Failure Patients (EFFECT)

Primary Purpose

Acute Myocardial Infarction, Congestive Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Publicly released hospital cardiac report cards
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Myocardial Infarction focused on measuring Acute myocardial infarction, Congestive heart failure, Quality of care, Reperfusion, Report cards, Quality indicators

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Hospital: Treat > 30 AMI/CHF cases/patients per year in Ontario Patient: AMI Most responsible diagnosis of acute myocardial infarction(ICD-9 code 410) CHF Most responsible diagnosis of heart failure(ICD-9 code 428) Exclusion Criteria: Patient AMI Not admitted to an acute care hospital AMI Age < 20 or > 105 years AMI Invalid health card number AMI Admitted to non-cardiac surgical service AMI Transferred from another acute care facility AMI coded as an in-hospital complication AMI admission within the past year CHF Not admitted to an acute care hospital CHF Age < 20 or > 105 years CHF Invalid health card number CHF Admitted to surgical service CHF Transferred from another acute care facility CHF coded as an in-hospital complication CHF admission within the past three years

Sites / Locations

  • Institute for Clinical Evaluative Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Early Feedback Arm

Delayed Feedback Arm

Arm Description

Hospital corporations randomized to receive early feedback in the form of a report card

Hospitals randomized to receive delayed feedback in the form of a hospital report cared, 21 months after the early feedback arm.

Outcomes

Primary Outcome Measures

EFFECT AMI Composite Quality Indicator in the year after report cards published
EFFECT CHF Composite Quality Indicator in the year after report cards published

Secondary Outcome Measures

CCORT/CCS Individual AMI Quality Indicators in the year after report cards published
CCORT/CCS Individual CHF Quality Indicators in the year after report cards published

Full Information

First Posted
September 13, 2005
Last Updated
November 30, 2009
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT00187460
Brief Title
Study of the Effectiveness of Report Cards on the Quality of Care for Heart Attack and Heart Failure Patients
Acronym
EFFECT
Official Title
Enhanced Feedback for Effective Cardiac Treatment (EFFECT)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2005
Overall Recruitment Status
Completed
Study Start Date
November 2001 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized cluster trial of cardiac report cards for AMI and CHF. 103 acute care Ontario hospitals/85 hospital corporations participating, randomized to two groups: Group A Early Feedback and Group B Delayed Feedback. Two phases of retrospective chart review of AMI and CHF separations to assess the impact of the public release of hospital specific performance on a set of Canadian quality indicators.
Detailed Description
Study Overview: The EFFECT Study is one of the largest and most comprehensive initiatives in the world to measure and improve the quality of cardiac care. A randomized trial of cardiac care report cards, the study's objective is to determine whether developing and publishing report cards based on clinical data collected from patient charts leads to greater use of evidence-based therapy at hospitals that receive them. The three-phase study focuses on acute myocardial infarction (AMI) and congestive heart failure (CHF) and involves 85 hospital corporations (consisting of 103 acute care hospitals) in Ontario. As part of the study design, the hospitals were randomized into two groups: Group A-Early feedback hospitals (44 hospital corporations/53 hospitals) and Group B-Delayed feedback hospitals (41 hospital corporations/50 hospitals). Phase I A retrospective chart review of hospitalizations from 1999/00 and 2000/01 was conducted in the participating Ontario hospital corporations. Findings from Phase I were documented in two reports: Report 1. Report Cards on Group A-Early Feedback Hospitals, released January 2004; Report 2. Report Cards on Group B-Delayed Feedback Hospitals, to be released September 2005. In addition to demographic and treatment information, study data also focus on two sets of quality indicators-one for AMI care and one for CHF care. Canadian Cardiovascular Outcomes Research Team (CCORT) investigators, in conjunction with the Canadian Cardiovascular Society (CCS), formed two expert panels to define Canadian AMI and CHF Quality Indicators. The expert panels' membership included clinical leaders in cardiology, internal medicine, family practice, nursing, pharmacy and epidemiology. The indicators are posted on the CCORT web site (www.ccort.ca) and have been published in the Canadian Journal of Cardiology. The study's Technical Advisory Committee reviewed all of the proposed AMI and CHF quality indicators and recommended a final list of indicators for inclusion in the EFFECT report cards. Phase II Report Cards for Group A-Early Feedback Hospitals and Group B-Delayed Feedback Hospitals based on a second phase of retrospective chart review of 2004/05 hospitalizations. (Release in 2006/07) Phase III Final Report-Impact Assessment: A comparison of results/improvement from Phase I to Phase II. (Release in 2006/07) Sources of Funding The EFFECT study is being funded by the Canadian Institutes of Health Research (CHIR) Interdisciplinary Health Research Team (IHRT) Program and the Heart and Stroke Foundation of Canada, with in kind support from the Institute for Clinical Evaluative Sciences. Principal Investigators The EFFECT study is being led by Dr. Jack V. Tu, MD, PhD, Senior Scientist, ICES, Canada Research Chair, Health Services Research.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Congestive Heart Failure
Keywords
Acute myocardial infarction, Congestive heart failure, Quality of care, Reperfusion, Report cards, Quality indicators

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
46000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early Feedback Arm
Arm Type
Active Comparator
Arm Description
Hospital corporations randomized to receive early feedback in the form of a report card
Arm Title
Delayed Feedback Arm
Arm Type
Active Comparator
Arm Description
Hospitals randomized to receive delayed feedback in the form of a hospital report cared, 21 months after the early feedback arm.
Intervention Type
Behavioral
Intervention Name(s)
Publicly released hospital cardiac report cards
Intervention Description
Participating hospital corporations were randomized to either early feedback or delayed feedback (21 months later) in the form of publicly released hospital report cards of performance on a set of cardiac process-of-care quality indicators.
Primary Outcome Measure Information:
Title
EFFECT AMI Composite Quality Indicator in the year after report cards published
Time Frame
April 1, 2004 - March 31, 2005
Title
EFFECT CHF Composite Quality Indicator in the year after report cards published
Time Frame
April 1, 2004 - March 31, 2005
Secondary Outcome Measure Information:
Title
CCORT/CCS Individual AMI Quality Indicators in the year after report cards published
Time Frame
April 1, 2004 - March 31, 2005
Title
CCORT/CCS Individual CHF Quality Indicators in the year after report cards published
Time Frame
April 1, 2004 - March 31, 2005

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Hospital: Treat > 30 AMI/CHF cases/patients per year in Ontario Patient: AMI Most responsible diagnosis of acute myocardial infarction(ICD-9 code 410) CHF Most responsible diagnosis of heart failure(ICD-9 code 428) Exclusion Criteria: Patient AMI Not admitted to an acute care hospital AMI Age < 20 or > 105 years AMI Invalid health card number AMI Admitted to non-cardiac surgical service AMI Transferred from another acute care facility AMI coded as an in-hospital complication AMI admission within the past year CHF Not admitted to an acute care hospital CHF Age < 20 or > 105 years CHF Invalid health card number CHF Admitted to surgical service CHF Transferred from another acute care facility CHF coded as an in-hospital complication CHF admission within the past three years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack V Tu, MD PhD FRCPC
Organizational Affiliation
Institute for Clinical Evaluative Studies, Sunnybrook & Women's College Health Sciences Centre, University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Clinical Evaluative Sciences
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada

12. IPD Sharing Statement

Citations:
Citation
Tu JV, Donovan LR, Lee DS, Austin PC, Ko DT, Wang JT, Newman AM. Quality of Cardiac Care in Ontario. ICES, Toronto, Ontario, 2004
Results Reference
result
PubMed Identifier
15729413
Citation
Jackevicius CA, Alter D, Cox J, Daly P, Goodman S, Filate W, Newman A, Tu JV; Canadian Cardiovascular Outcomes Research Team. Acute treatment of myocardial infarction in Canada 1999-2002. Can J Cardiol. 2005 Feb;21(2):145-52.
Results Reference
result
PubMed Identifier
14625335
Citation
Lee DS, Austin PC, Rouleau JL, Liu PP, Naimark D, Tu JV. Predicting mortality among patients hospitalized for heart failure: derivation and validation of a clinical model. JAMA. 2003 Nov 19;290(19):2581-7. doi: 10.1001/jama.290.19.2581.
Results Reference
result
PubMed Identifier
19923205
Citation
Tu JV, Donovan LR, Lee DS, Wang JT, Austin PC, Alter DA, Ko DT. Effectiveness of public report cards for improving the quality of cardiac care: the EFFECT study: a randomized trial. JAMA. 2009 Dec 2;302(21):2330-7. doi: 10.1001/jama.2009.1731. Epub 2009 Nov 18.
Results Reference
result
Links:
URL
http://www.ccort.ca/EFFECTStudy/tabid/64/Default.aspx
Description
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Study of the Effectiveness of Report Cards on the Quality of Care for Heart Attack and Heart Failure Patients

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