Clinical Pathways for Effective and Appropriate Care

Stroke Clinical Trial

Official title:

Diffusion of Clinical Pathways for the Implementation of Effective and Appropriate Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00673491
• Other study ID #: DCPIEAC-EXART12MARCHE
• Status: Completed
• Phase: N/A
• First received: May 5, 2008
• Last updated: May 6, 2008
• Start date: July 2005
• Est. completion date: May 2007

Study information

• Verified date: May 2008
• Source: Agenzia Regionale Sanitaria delle Marche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 448
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (11)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality		30 days after hospital admission	Yes
Secondary	Disability		At hospital discharge	No