Clinical Pathways for Effective and Appropriate Care

This study has been completed.
Sponsor:
Collaborators:
Agenzia Nazionale per i Servizi Sanitari Regionali
Regione Friuli Venezia Giulia
Regione Calabria
Forum della Solidarieta
IRCCS Besta
Regione Molise
Regione Puglia
Regione Siciliana
Regione Umbria
University of Eastern Piedmont
Information provided by:
Agenzia Regionale Sanitaria delle Marche
ClinicalTrials.gov Identifier:
NCT00673491
First received: May 5, 2008
Last updated: May 6, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention
Stroke
Other: Clinical Pathways

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Diffusion of Clinical Pathways for the Implementation of Effective and Appropriate Care

Resource links provided by NLM:


Further study details as provided by Agenzia Regionale Sanitaria delle Marche:

Primary Outcome Measures:
  • Mortality [ Time Frame: 30 days after hospital admission ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Disability [ Time Frame: At hospital discharge ] [ Designated as safety issue: No ]

Enrollment: 448
Study Start Date: July 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients treated according to clinical pathways
Other: 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. 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.
No Intervention: 2
Patients treated according to usual care

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00673491

Sponsors and Collaborators
Agenzia Regionale Sanitaria delle Marche
Agenzia Nazionale per i Servizi Sanitari Regionali
Regione Friuli Venezia Giulia
Regione Calabria
Forum della Solidarieta
IRCCS Besta
Regione Molise
Regione Puglia
Regione Siciliana
Regione Umbria
University of Eastern Piedmont
Investigators
Study Chair: Francesco Di Stanislao, MD Agenzia Regionale Sanitaria delle Marche
  More Information

No publications provided by Agenzia Regionale Sanitaria delle Marche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andrea Gardini, Agenzia Regionale Sanitaria delle Marche
ClinicalTrials.gov Identifier: NCT00673491     History of Changes
Other Study ID Numbers: DCPIEAC-EXART12MARCHE
Study First Received: May 5, 2008
Last Updated: May 6, 2008
Health Authority: Italy: Ministry of Health

Keywords provided by Agenzia Regionale Sanitaria delle Marche:
Critical Pathways
Stroke
Randomized Controlled Trial
Effectiveness

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014