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Clinical Pathways for Effective and Appropriate Care

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical Pathways
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 Stroke focused on measuring Critical Pathways, Stroke, Randomized Controlled Trial, Effectiveness

Eligibility Criteria

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

Inclusion Criteria:

  • Principal diagnosis of Ischemic Stroke (ICD9CM code 434.91)

Exclusion Criteria:

  • Transient cerebral ischemia (ICD9CM code 435.9)
  • Intracerebral hemorrhage (ICD9CM codes 431.xx)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    1

    2

    Arm Description

    Patients treated according to clinical pathways

    Patients treated according to usual care

    Outcomes

    Primary Outcome Measures

    Mortality

    Secondary Outcome Measures

    Disability

    Full Information

    First Posted
    May 5, 2008
    Last Updated
    May 6, 2008
    Sponsor
    Agenzia Regionale Sanitaria delle Marche
    Collaborators
    Agenzia Nazionale per i Servizi Sanitari Regionali, Regione Friuli Venezia Giulia, Reggio Calabria, Forum della Solidarieta, IRCCS Besta, Regione Molise, Regione Puglia, Regione Siciliana, Regione Umbria, University of Eastern Piedmont
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00673491
    Brief Title
    Clinical Pathways for Effective and Appropriate Care
    Official Title
    Diffusion of Clinical Pathways for the Implementation of Effective and Appropriate Care
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2005 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Agenzia Regionale Sanitaria delle Marche
    Collaborators
    Agenzia Nazionale per i Servizi Sanitari Regionali, Regione Friuli Venezia Giulia, Reggio Calabria, Forum della Solidarieta, IRCCS Besta, Regione Molise, Regione Puglia, Regione Siciliana, Regione Umbria, University of Eastern Piedmont

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purposes of this study are to determine whether clinical pathways: 1)improve the quality of the care provided to patients affected by stroke in terms of clinical outcomes, efficiency continuity of care and patients' satisfaction; 2) facilitate the use of evidence based medicine in clinical practice.
    Detailed Description
    The coordination of care has been proved to be able to improve prognosis in acute stroke patients. Prompt identification of symptoms, organised timely and efficient transportation towards appropriate facilities, has become essential part of effective treatment, as well as organized rehabilitation. The importance of organized stroke care in facilitating recovery has been recognized for the last 10 years, but it is still unclear how organized care contributes to improved outcomes. Since clinical pathways aim to promote evidence- and guideline-based care, improve the organisation and efficiency of care, and reduce cost, their implementation may be a method for achieving the organizational standards required to grant appropriate care in stroke. Even though in the past decade, care pathways have been increasingly implemented as a tool in acute stroke care and stroke rehabilitation the evidence supports partially the use of clinical pathways in stroke because very little prospective controlled data demonstrated their effectiveness through the continuum of the care. Our study was designed in order to conduct a rigorous evaluation of clinical pathways for treatment of acute stroke patients in different types of organized stroke care.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stroke
    Keywords
    Critical Pathways, Stroke, 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
    448 (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
    No Intervention
    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. Defining characteristics of clinical pathways includes: an explicit statement of the goals and key elements of care based on evidence, best practice, and patient expectations; the facilitation of the communication, coordination of roles, and sequencing the activities of the multidisciplinary care team, patients and their relatives; the documentation, monitoring, and evaluation of variances and outcomes; and the identification of the appropriate resources.
    Primary Outcome Measure Information:
    Title
    Mortality
    Time Frame
    30 days after hospital admission
    Secondary Outcome Measure Information:
    Title
    Disability
    Time Frame
    At hospital discharge

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Principal diagnosis of Ischemic Stroke (ICD9CM code 434.91) Exclusion Criteria: Transient cerebral ischemia (ICD9CM code 435.9) Intracerebral hemorrhage (ICD9CM codes 431.xx)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francesco Di Stanislao, MD
    Organizational Affiliation
    Agenzia Regionale Sanitaria delle Marche
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22781160
    Citation
    Panella M, Marchisio S, Brambilla R, Vanhaecht K, Di Stanislao F. A cluster randomized trial to assess the effect of clinical pathways for patients with stroke: results of the clinical pathways for effective and appropriate care study. BMC Med. 2012 Jul 10;10:71. doi: 10.1186/1741-7015-10-71.
    Results Reference
    derived
    PubMed Identifier
    18980664
    Citation
    Panella M, Marchisio S, Barbieri A, Di Stanislao F. A cluster randomized trial to assess the impact of clinical pathways for patients with stroke: rationale and design of the Clinical Pathways for Effective and Appropriate Care Study [NCT00673491]. BMC Health Serv Res. 2008 Nov 3;8:223. doi: 10.1186/1472-6963-8-223.
    Results Reference
    derived

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    Clinical Pathways for Effective and Appropriate Care

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