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

A

Agenzia Regionale Sanitaria delle Marche

Status

Completed

Conditions

Congestive Heart Failure

Treatments

Other: Clinical Pathways
Other: Usual Care

Study type

Interventional

Funder types

Other

Identifiers

NCT00519038
EPSEEIC2004-EXART12MARCHE

Details and patient eligibility

About

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.

Full 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.

Enrollment

424 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

424 participants in 2 patient groups

1
Experimental group
Description:
Patients treated according to clinical pathways
Treatment:
Other: Clinical Pathways
2
Other group
Description:
Patients treated according to usual care
Treatment:
Other: Usual Care

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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