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Open Access Research article

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

Massimiliano Panella15*, Sara Marchisio12, Romeo Brambilla3, Kris Vanhaecht45 and Francesco Di Stanislao2

Author Affiliations

1 Department of Clinical and Experimental Medicine, University of Eastern Piedmont 'A. Avogadro', Novara, Italy

2 Unit for Quality Improvement, Health Authority ASL VC, Vercelli, Italy

3 Unit of Epidemiology, School of Public Health, Grugliasco, Turin, Italy

4 Center for Health Services and Nursing Research, School of Public Health, Catholic University Leuven, Leuven, Belgium

5 The European Pathway Association, Leuven, Belgium

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BMC Medicine 2012, 10:71  doi:10.1186/1741-7015-10-71

Published: 10 July 2012

Abstract

Background

Clinical pathways (CPs) are used to improve the outcomes of acute stroke, but their use in stroke care is questionable, because the evidence on their effectiveness is still inconclusive. The objective of this study was to evaluate whether CPs improve the outcomes and the quality of care provided to patients after acute ischemic stroke.

Methods

This was a multicentre cluster-randomized trial, in which 14 hospitals were randomized to the CP arm or to the non intervention/usual care (UC) arm. Healthcare workers in the CP arm received 3 days of training in quality improvement of CPs and in use of a standardized package including information on evidence-based key interventions and indicators. Healthcare workers in the usual-care arm followed their standard procedures. The teams in the CP arm developed their CPs over a 6-month period. The primary end point was mortality. Secondary end points were: use of diagnostic and therapeutic procedures, implementation of organized care, length of stay, re-admission and institutionalization rates after discharge, dependency levels, and complication rates.

Results

Compared with the patients in the UC arm, the patients in the CP arm had a significantly lower risk of mortality at 7 days (OR = 0.10; 95% CI 0.01 to 0.95) and significantly lower rates of adverse functional outcomes, expressed as the odds of not returning to pre-stroke functioning in their daily life (OR = 0.42; 95 CI 0.18 to 0.98). There was no significant effect on 30-day mortality. Compared with the UC arm, the hospital diagnostic and therapeutic procedures were performed more appropriately in the CP arm, and the evidence-based key interventions and organized care were more applied in the CP arm.

Conclusions

CPs can significantly improve the outcomes of patients with ischemic patients with stroke, indicating better application of evidence-based key interventions and of diagnostic and therapeutic procedures. This study tested a new hypothesis and provided evidence on how CPs can work.

Trial registration

ClinicalTrials.gov ID: [NCT00673491].