Clinical Pathways for Effective and Appropriate Care

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Clinical Pathways

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.

• Study Type: Interventional
• Enrollment (Actual): 448
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality	30 days after hospital admission

Secondary Outcome Measures

Outcome Measure	Time Frame
Disability	At hospital discharge

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2005
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): May 1, 2007

Study Registration Dates

• First Submitted: May 5, 2008
• First Submitted That Met QC Criteria: May 6, 2008
• First Posted (Estimate): May 7, 2008

Study Record Updates

• Last Update Posted (Estimate): May 7, 2008
• Last Update Submitted That Met QC Criteria: May 6, 2008
• Last Verified: May 1, 2008

More Information

Terms related to this study

• Keywords: Stroke; Randomized Controlled Trial; Effectiveness; Critical Pathways
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: DCPIEAC-EXART12MARCHE