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Clinical Pathways for Effective and Appropriate Care

NCT ID: NCT00673491

Last Updated: 2008-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

448 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2007-05-31

Brief Summary

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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

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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.

Conditions

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Stroke

Keywords

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Critical Pathways Stroke Randomized Controlled Trial Effectiveness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

Patients treated according to clinical pathways

Group Type EXPERIMENTAL

Clinical Pathways

Intervention Type OTHER

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

Patients treated according to usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Agenzia Nazionale per i Servizi Sanitari Regionali

OTHER

Sponsor Role collaborator

Regione Friuli Venezia Giulia

UNKNOWN

Sponsor Role collaborator

Reggio Calabria

OTHER

Sponsor Role collaborator

Forum della Solidarieta

UNKNOWN

Sponsor Role collaborator

IRCCS Besta

UNKNOWN

Sponsor Role collaborator

Regione Molise

UNKNOWN

Sponsor Role collaborator

Regione Puglia

UNKNOWN

Sponsor Role collaborator

Regione Siciliana

UNKNOWN

Sponsor Role collaborator

Regione Umbria

UNKNOWN

Sponsor Role collaborator

University of Eastern Piedmont

OTHER

Sponsor Role collaborator

Agenzia Regionale Sanitaria delle Marche

OTHER_GOV

Sponsor Role lead

Responsible Party

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Agenzia Regionale Sanitaria delle Marche

Principal Investigators

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Francesco Di Stanislao, MD

Role: STUDY_CHAIR

Agenzia Regionale Sanitaria delle Marche

References

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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.

Reference Type DERIVED
PMID: 22781160 (View on PubMed)

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.

Reference Type DERIVED
PMID: 18980664 (View on PubMed)

Other Identifiers

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DCPIEAC-EXART12MARCHE

Identifier Type: -

Identifier Source: org_study_id