- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00187460
Study of the Effectiveness of Report Cards on the Quality of Care for Heart Attack and Heart Failure Patients (EFFECT)
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.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Ontario
-
Toronto, Ontario, Canadá, M4N 3M5
- Institute for Clinical Evaluative Sciences
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Early Feedback Arm
Hospital corporations randomized to receive early feedback in the form of a report card
|
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.
|
Comparador activo: Delayed Feedback Arm
Hospitals randomized to receive delayed feedback in the form of a hospital report cared, 21 months after the early feedback arm.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
EFFECT AMI Composite Quality Indicator in the year after report cards published
Periodo de tiempo: April 1, 2004 - March 31, 2005
|
April 1, 2004 - March 31, 2005
|
EFFECT CHF Composite Quality Indicator in the year after report cards published
Periodo de tiempo: April 1, 2004 - March 31, 2005
|
April 1, 2004 - March 31, 2005
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
CCORT/CCS Individual AMI Quality Indicators in the year after report cards published
Periodo de tiempo: April 1, 2004 - March 31, 2005
|
April 1, 2004 - March 31, 2005
|
CCORT/CCS Individual CHF Quality Indicators in the year after report cards published
Periodo de tiempo: April 1, 2004 - March 31, 2005
|
April 1, 2004 - March 31, 2005
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jack V Tu, MD PhD FRCPC, Institute for Clinical Evaluative Studies, Sunnybrook & Women's College Health Sciences Centre, University of Toronto
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- 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. doi: 10.1001/jama.290.19.2581.
- 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 Nov 18.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRT43823
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Insuficiencia cardíaca congestiva
-
Region SkaneInscripción por invitaciónInsuficiencia cardíaca New York Heart Association (NYHA) Clase II | Insuficiencia cardíaca New York Heart Association (NYHA) Clase IIISuecia
-
Medical University of BialystokInstitute of Cardiology, Warsaw, Poland; Medical University of Lodz; Poznan University... y otros colaboradoresAún no reclutandoInsuficiencia Cardíaca Sistólica | Insuficiencia cardíaca con fracción de eyección reducida | Insuficiencia cardíaca Clase IV de la New York Heart Association | Insuficiencia cardíaca Clase III de la New York Heart AssociationPolonia
-
Novartis PharmaceuticalsTerminadoPacientes que completaron con éxito el período de tratamiento de 12 meses del estudio principal (receptores de Novo Heart) que estaban interesados en recibir tratamiento con EC-MPS
-
University of WashingtonAmerican Heart AssociationTerminadoInsuficiencia cardíaca, congestiva | Alteración mitocondrial | Insuficiencia cardíaca Clase IV de la New York Heart AssociationEstados Unidos