Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways (EPSEEIC2004)
Primary Purpose
Congestive Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical Pathways
Usual Care
Sponsored by

About this trial
This is an interventional health services research trial for Congestive Heart Failure focused on measuring Critical Pathways, Congestive Heart Failure, Randomized Controlled Trial, Effectiveness
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
1
2
Arm Description
Patients treated according to clinical pathways
Patients treated according to usual care
Outcomes
Primary Outcome Measures
In-hospital mortality
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.
Full Information
NCT ID
NCT00519038
First Posted
August 20, 2007
Last Updated
August 20, 2007
Sponsor
Agenzia Regionale Sanitaria delle Marche
1. Study Identification
Unique Protocol Identification Number
NCT00519038
Brief Title
Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways
Acronym
EPSEEIC2004
Official Title
Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Agenzia Regionale Sanitaria delle Marche
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure
Keywords
Critical Pathways, Congestive Heart Failure, Randomized Controlled Trial, Effectiveness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
424 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Patients treated according to clinical pathways
Arm Title
2
Arm Type
Other
Arm Description
Patients treated according to usual care
Intervention Type
Other
Intervention Name(s)
Clinical Pathways
Intervention Description
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
Intervention Name(s)
Usual Care
Intervention Description
Usual care is the current practice actually performed in the hospital
Primary Outcome Measure Information:
Title
In-hospital mortality
Time Frame
during the stay
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Gardini, MD
Organizational Affiliation
Agenzia Regionale Sanitaria delle Marche
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
19812099
Citation
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.
Results Reference
derived
PubMed Identifier
17986361
Citation
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.
Results Reference
derived
Learn more about this trial
Experimental Prospective Study on the Effectiveness and Efficiency of the Implementation of Clinical Pathways
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