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

Congestive Heart Failure Clinical Trial

— EPSEEIC2004  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519038
• Other study ID #: EPSEEIC2004-EXART12MARCHE
• Status: Completed
• Phase: N/A
• First received: August 20, 2007
• Last updated: August 20, 2007
• Start date: March 2003
• Est. completion date: December 2006

Study information

• Verified date: August 2007
• Source: Agenzia Regionale Sanitaria delle Marche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 424
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

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
• Usual Care
Usual care is the current practice actually performed in the hospital

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Agenzia Regionale Sanitaria delle Marche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality		during the stay
Secondary	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.		during the stay or at discharge