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

Not Applicable

Completed

• Conditions: Congestive Heart Failure
• Interventions: Other: Clinical Pathways; Other: Usual Care

• Registration Number: NCT00519038
• Lead Sponsor: Agenzia Regionale Sanitaria delle Marche

Brief 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.

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.

Study Timeline

• Study Start: 2003-03
• Study Completion: 2006-12
• Status Verified: 2007-08
• Study First Submitted: 2007-08-20
• Study First Submitted QC: 2007-08-20
• Last Update Submitted: 2007-08-20
• Study First Posted: 2007-08-21
• Last Update Posted: 2007-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 424

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Clinical Pathways	Patients treated according to clinical pathways
2	Usual Care	Patients treated according to usual care

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	during the stay

Secondary Outcome Measures

Name	Time	Method
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