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

Acute Myocardial Infarction Clinical Trial

— EFFECT  

Official title:

Enhanced Feedback for Effective Cardiac Treatment (EFFECT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00187460
• Other study ID #: CRT43823
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 30, 2009
• Start date: November 2001
• Est. completion date: March 2009

Study information

• Verified date: May 2005
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46000
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Congestive Heart Failure
• Heart Failure
• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• Publicly released hospital cardiac report cards
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.

Locations

Country	Name	City	State
Canada	Institute for Clinical Evaluative Sciences	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View 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. — View 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 N — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EFFECT AMI Composite Quality Indicator in the year after report cards published		April 1, 2004 - March 31, 2005	No
Primary	EFFECT CHF Composite Quality Indicator in the year after report cards published		April 1, 2004 - March 31, 2005	No
Secondary	CCORT/CCS Individual AMI Quality Indicators in the year after report cards published		April 1, 2004 - March 31, 2005	No
Secondary	CCORT/CCS Individual CHF Quality Indicators in the year after report cards published		April 1, 2004 - March 31, 2005	No

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