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Sponsored by: |
Agenzia Regionale Sanitaria delle Marche |
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Information provided by: | Agenzia Regionale Sanitaria delle Marche |
ClinicalTrials.gov Identifier: | NCT00519038 |
The purpose of this study is to determine whether the use of clinical pathways improves the quality of the hospital care of decompensated heart failure patients.
Condition | Intervention |
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Congestive Heart Failure |
Other: Clinical Pathways Other: Usual Care |
Study Type: | Interventional |
Study Design: | Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways |
Enrollment: | 424 |
Study Start Date: | March 2003 |
Study Completion Date: | December 2006 |
Arms | Assigned Interventions |
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1: Experimental
Patients treated according to clinical pathways
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Other: Clinical Pathways
Clinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period with the aim to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. They are also developed by multi-professional teams
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2
Patients treated according to usual care
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Other: Usual Care
Usual care is the current practice actually performed in the hospital
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In Europe approximately 5% of all acute medical admissions relate to heart failure and in the United States heart failure is responsible for almost 1 million hospitalizations annually. Almost three quarters of these admissions are unplanned and worsening heart failure is responsible for half of these admissions.
The Acute Decompensated Heart Failure National Registry (ADHERE) showed that the hospital treatment of heart failure frequently does not follow published guidelines or conform to the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) core performance measures, potentially contributing to the high morbidity, mortality and economic cost of this disorder. ADHERE findings also suggested that the wide variations in conformity may reflect differences in training, guideline familiarity, and implementation of tools and systems to ensure that recommended care is provided and documented. Consequently the development of educational and quality improvement programs has the potential to considerably reduce the current variability in care, enhance guideline adherence, and improve outcomes for patients.
Clinical pathways has become a popular tool to achieve such goals. Clinical pathways are a methodology for the mutual decision making and organization of care for a well-defined group of patients during a well-defined period with the aim to enhance the quality of care by improving patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. They are also developed by multi-professional teams. Despite enthusiasm and diffusion, the widespread acceptance of clinical pathways remain questionable because very little prospective controlled data demonstrated their effectiveness.
The Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways was designed in order to conduct a rigorous evaluation of a clinical pathway in hospital treatment of decompensated heart failure.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | EPSEEIC2004-EXART12MARCHE |
Study First Received: | August 20, 2007 |
Last Updated: | August 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00519038 |
Health Authority: | Italy: Ministry of Health |
Critical Pathways Congestive Heart Failure Randomized Controlled Trial Effectiveness |
Heart Failure Heart Diseases |
Cardiovascular Diseases |