Acute Myocardial InfarctionEFFECTNCT00187460
Study of the Effectiveness of Report Cards on the Quality of Care for Heart Attack and Heart Failure Patients
A study testing Publicly released hospital cardiac report cards in people with Acute Myocardial Infarction and Congestive Heart Failure, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Acute Myocardial Infarction, Congestive Heart Failure
- What is being tested?
- Publicly released hospital cardiac report cards
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46,000 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2001to Mar 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institute for Clinical Evaluative Sciences
Toronto, Ontario, M4N 3M5
About this study
Official title: Enhanced Feedback for Effective Cardiac Treatment (EFFECT)
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.
Read the 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.
- Being tested
- Publicly released hospital cardiac report cards
- Keywords
- Acute myocardial infarction, Congestive heart failure, Quality of care, Reperfusion, Report cards, Quality indicators
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Publicly released hospital cardiac report cardsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Early Feedback Arm | Active comparator | Hospital corporations randomized to receive early feedback in the form of a report card Receives: Behavioral: Publicly released hospital cardiac report cards |
| Delayed Feedback Arm | Active comparator | Hospitals randomized to receive delayed feedback in the form of a hospital report cared, 21 months after the early feedback arm. Receives: Behavioral: Publicly released hospital cardiac report cards |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFECT AMI Composite Quality Indicator in the year after report cards published
Measured: April 1, 2004 - March 31, 2005
EFFECT CHF Composite Quality Indicator in the year after report cards published
Measured: April 1, 2004 - March 31, 2005
Secondary outcomes (2)
CCORT/CCS Individual AMI Quality Indicators in the year after report cards published
Measured: April 1, 2004 - March 31, 2005
CCORT/CCS Individual CHF Quality Indicators in the year after report cards published
Measured: April 1, 2004 - March 31, 2005
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2001
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario
- Investigators
- Jack V Tu, MD PhD FRCPC, Principal investigator, Institute for Clinical Evaluative Studies, Sunnybrook & Women's College Health Sciences Centre, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00187460
- Sponsor's protocol ID
- CRT43823
- Acronym
- EFFECT
- Status last verified
- May 2005
- First submitted
- 13 Sep 2005
- Last updated
- 1 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Tu JV, Donovan LR, Lee DS, Austin PC, Ko DT, Wang JT, Newman AM. Quality of Cardiac Care in Ontario. ICES, Toronto, Ontario, 2004
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.
PubMed 15729413Lee 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.
PubMed 14625335Tu 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.
PubMed 19923205
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Feedback for Effective Cardiac Treatment (EFFECT)
- ClinicalTrials.gov ID
- NCT00187460
- Acronym / sponsor ID
- EFFECT / CRT43823
- Keywords
- Acute myocardial infarction, Congestive heart failure, Quality of care, Reperfusion, Report cards, Quality indicators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46,000 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Heart and Stroke Foundation of Ontario
- Study start
- Nov 2001
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Feedback Arm | Active comparator | Behavioral: Publicly released hospital cardiac report cardsHospital corporations randomized to receive early feedback in the form of a report card |
| Delayed Feedback Arm | Active comparator | Behavioral: Publicly released hospital cardiac report cardsHospitals randomized to receive delayed feedback in the form of a hospital report cared, 21 months after the early feedback arm. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Publicly released hospital cardiac report cardsParticipating 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. | Behavioural | Delayed Feedback Arm, Early Feedback Arm |
Primary outcome
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
2 secondary outcomes
CCORT/CCS Individual AMI Quality Indicators in the year after report cards published
Time frame: April 1, 2004 - March 31, 2005
CCORT/CCS Individual CHF Quality Indicators in the year after report cards published
Time frame: April 1, 2004 - March 31, 2005
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2009.
- Results publicationTu JV, Donovan LR, Lee DS, Austin PC, Ko DT, Wang JT, Newman AM. Quality of Cardiac Care in Ontario. ICES, Toronto, Ontario, 2004
- Results publication: PubMed 15729413Jackevicius 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 publication: PubMed 14625335Lee 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 publication: PubMed 19923205Tu 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack V Tu, MD PhD FRCPC principal investigator
Institute for Clinical Evaluative Studies, Sunnybrook & Women's College Health Sciences Centre, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Publicly released hospital cardiac report cards in people with Acute Myocardial Infarction and Congestive Heart Failure, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EFFECT AMI Composite Quality Indicator in the year after report cards published (time frame: April 1, 2004 - March 31, 2005). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00187460, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2009.