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

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Ontario
Information provided by:
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT00187460
First received: September 13, 2005
Last updated: November 30, 2009
Last verified: May 2005
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Congestive Heart Failure
Behavioral: Publicly released hospital cardiac report cards

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Enhanced Feedback for Effective Cardiac Treatment (EFFECT)

Resource links provided by NLM:


Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • EFFECT AMI Composite Quality Indicator in the year after report cards published [ Time Frame: April 1, 2004 - March 31, 2005 ] [ Designated as safety issue: No ]
  • EFFECT CHF Composite Quality Indicator in the year after report cards published [ Time Frame: April 1, 2004 - March 31, 2005 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • CCORT/CCS Individual AMI Quality Indicators in the year after report cards published [ Time Frame: April 1, 2004 - March 31, 2005 ] [ Designated as safety issue: No ]
  • CCORT/CCS Individual CHF Quality Indicators in the year after report cards published [ Time Frame: April 1, 2004 - March 31, 2005 ] [ Designated as safety issue: No ]

Enrollment: 46000
Study Start Date: November 2001
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Early Feedback Arm
Hospital corporations randomized to receive early feedback in the form of a report card
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.
Active Comparator: Delayed Feedback Arm
Hospitals randomized to receive delayed feedback in the form of a hospital report cared, 21 months after the early feedback arm.
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00187460

Locations
Canada, Ontario
Institute for Clinical Evaluative Sciences
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Canadian Institutes of Health Research (CIHR)
Heart and Stroke Foundation of Ontario
Investigators
Principal Investigator: Jack V Tu, MD PhD FRCPC Institute for Clinical Evaluative Studies, Sunnybrook & Women's College Health Sciences Centre, University of Toronto
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Jack V. Tu, PI, Institute for Clinical Evaluative Sciences
ClinicalTrials.gov Identifier: NCT00187460     History of Changes
Other Study ID Numbers: CRT43823
Study First Received: September 13, 2005
Last Updated: November 30, 2009
Health Authority: Canada: Health Canada

Keywords provided by Sunnybrook Health Sciences Centre:
Acute myocardial infarction
Congestive heart failure
Quality of care
Reperfusion
Report cards
Quality indicators

Additional relevant MeSH terms:
Heart Failure
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on September 16, 2014