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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
Agenzia Regionale Sanitaria delle Marche
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    August 20, 2007
    Last Updated
    August 20, 2007
    Sponsor
    Agenzia Regionale Sanitaria delle Marche
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    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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