Enhanced Feedback for Effective Cardiac Treatment (EFFECT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 46,000
- Locations
- 1
- Primary Endpoint
- EFFECT AMI Composite Quality Indicator in the year after report cards published
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Hospital: Treat > 30 AMI/CHF cases/patients per year in Ontario
- •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
- •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
Arms & Interventions
Early Feedback Arm
Hospital corporations randomized to receive early feedback in the form of a report card
Intervention: Publicly released hospital cardiac report cards (Behavioral)
Delayed Feedback Arm
Hospitals randomized to receive delayed feedback in the form of a hospital report cared, 21 months after the early feedback arm.
Intervention: Publicly released hospital cardiac report cards (Behavioral)
Outcomes
Primary Outcomes
EFFECT AMI Composite Quality Indicator in the year after report cards published
Time Frame: April 1, 2004 - March 31, 2005
EFFECT CHF Composite Quality Indicator in the year after report cards published
Time Frame: April 1, 2004 - March 31, 2005
Secondary Outcomes
- CCORT/CCS Individual AMI Quality Indicators in the year after report cards published(April 1, 2004 - March 31, 2005)
- CCORT/CCS Individual CHF Quality Indicators in the year after report cards published(April 1, 2004 - March 31, 2005)