Clinical trial NCT00673491: Clinical Pathways for Effective and Appropriate Care
Official title: Diffusion of Clinical Pathways for the Implementation of Effective and Appropriate Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Critical Pathways
Stroke
Randomized Controlled Trial
Effectiveness
Lead sponsor: Agenzia Regionale Sanitaria delle Marche
Sponsor class: OTHER_GOV
Collaborators: name: Agenzia Nazionale per i Servizi Sanitari Regionali
name: Regione Friuli Venezia Giulia
name: Reggio Calabria
name: Forum della Solidarieta
name: IRCCS Besta
name: Regione Molise
name: Regione Puglia
name: Regione Siciliana
name: Regione Umbria
name: University of Eastern Piedmont
First posted: 2008-05-07
Enrollment: 448
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Mortality
timeFrame: 30 days after hospital admission
Secondary outcomes:
measure: Disability
timeFrame: At hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: Agenzia Regionale Sanitaria delle Marche
name: Francesco Di Stanislao, MD
role: STUDY_CHAIR
References:
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.
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.