Clinical Pathways for Effective and Appropriate Care
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Clinical Pathways
Sponsored by

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
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
NCT ID
NCT00673491
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
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
Learn more about this trial
Clinical Pathways for Effective and Appropriate Care
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