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

NCT ID: NCT00519038

Last Updated: 2007-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 424 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2006-12-31

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.

Conditions

Congestive Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

1

Patients treated according to clinical pathways

Group Type: EXPERIMENTAL

Clinical Pathways

Intervention Type: OTHER

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

Group Type: OTHER

Usual Care

Intervention Type: OTHER

Usual care is the current practice actually performed in the hospital

Interventions

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

Intervention Type: OTHER

Usual Care

Usual care is the current practice actually performed in the hospital

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agenzia Regionale Sanitaria delle Marche

OTHER_GOV

Sponsor Role: lead

Principal Investigators

Andrea Gardini, MD

Role: STUDY_CHAIR

Agenzia Regionale Sanitaria delle Marche

References

Panella M, Marchisio S, Demarchi ML, Manzoli L, Di Stanislao F. Reduced in-hospital mortality for heart failure with clinical pathways: the results of a cluster randomised controlled trial. Qual Saf Health Care. 2009 Oct;18(5):369-73. doi: 10.1136/qshc.2008.026559.

Reference Type: DERIVED

PMID: 19812099 (View on PubMed)

Panella M, Marchisio S, Gardini A, Di Stanislao F. A cluster randomized controlled trial of a clinical pathway for hospital treatment of heart failure: study design and population. BMC Health Serv Res. 2007 Nov 7;7:179. doi: 10.1186/1472-6963-7-179.

Reference Type: DERIVED

PMID: 17986361 (View on PubMed)

Other Identifiers

EPSEEIC2004-EXART12MARCHE

Identifier Type: -

Identifier Source: org_study_id