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Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways (EPSEEIC2004)

This study has been completed.
Sponsor:
Information provided by:
Agenzia Regionale Sanitaria delle Marche
ClinicalTrials.gov Identifier:
NCT00519038
First received: August 20, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
  Purpose

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
Congestive Heart Failure
 Other: Clinical Pathways
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Further study details as provided by Agenzia Regionale Sanitaria delle Marche:

Primary Outcome Measures:
  • In-hospital mortality [ Time Frame: during the stay ]

Secondary Outcome Measures:
  • Appropriateness of the stay; Rate of unscheduled readmissions; Length of the stay; Cost of the admission; Patients' satisfaction score; Use of diagnostic procedures; Use of medical treatments. [ Time Frame: during the stay or at discharge ]

Enrollment: 424
Study Start Date: March 2003
Study Completion Date: December 2006
Arms Assigned Interventions
Experimental: 1
Patients treated according to clinical pathways
 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
2
Patients treated according to usual care
 Other: Usual Care
Usual care is the current practice actually performed in the hospital

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • principal diagnosis of heart failure (all ICD-9 codes included in 428.xx code)

Exclusion Criteria:

  • current acute myocardial infarction (AMI)
  • current unstable angina
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00519038

Sponsors and Collaborators
Agenzia Regionale Sanitaria delle Marche
Investigators
Study Chair: Andrea Gardini, MD Agenzia Regionale Sanitaria delle Marche
  More Information

No publications provided by Agenzia Regionale Sanitaria delle Marche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00519038     History of Changes
Other Study ID Numbers: EPSEEIC2004-EXART12MARCHE
Study First Received: August 20, 2007
Last Updated: August 20, 2007
Health Authority: Italy: Ministry of Health

Keywords provided by Agenzia Regionale Sanitaria delle Marche:
Critical Pathways
Congestive Heart Failure
Randomized Controlled Trial
Effectiveness

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013