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Completed

NCT Number: NCT00187460

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institute for Clinical Evaluative Sciences

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Publicly released hospital cardiac report cards

Behavioral

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 outcomes

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

    Time frame: April 1, 2004 - March 31, 2005

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

    Time frame: April 1, 2004 - March 31, 2005

Secondary outcomes

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

    Time frame: April 1, 2004 - March 31, 2005

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

    Time frame: April 1, 2004 - March 31, 2005

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Heart and Stroke Foundation of Ontario

Registry information

Official study title

Enhanced Feedback for Effective Cardiac Treatment (EFFECT)

Acronym: EFFECT

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Sep 16, 2005
Registry last updated
Dec 1, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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