Clinical Pathways for Effective and Appropriate Care - Full Text View

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
Information provided by:	Agenzia Regionale Sanitaria delle Marche
ClinicalTrials.gov Identifier:	NCT00673491

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Diffusion of Clinical Pathways for the Implementation of Effective and Appropriate Care

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
1: Experimental 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.
2: No Intervention Patients treated according to usual care

Arms

Assigned Interventions

1: Experimental

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.

2: No Intervention

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

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

Publications indexed to this study:

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.

Responsible Party:	Agenzia Regionale Sanitaria delle Marche ( Andrea Gardini )
Study ID Numbers:	DCPIEAC-EXART12MARCHE
Study First Received:	May 5, 2008
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00673491
Health Authority:	Italy: Ministry of Health

Keywords provided by Agenzia Regionale Sanitaria delle Marche:

Critical Pathways
Stroke
Randomized Controlled Trial
Effectiveness

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases

Central Nervous System Diseases
Brain Diseases
Cerebrovascular Disorders

Additional relevant MeSH terms:

Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009