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]

Stroke represents one of the major public health problems worldwide. Despite advances in stroke prevention, diagnosis, treatment, and rehabilitation, stroke causes 9% of all the deaths around the world and stroke-related disability has been judged to be one of the most common causes of disability. In industrialized countries stroke remains a major cause of acute hospitalization with mortality rates at 28 days following the acute onset at approximately 20%. This accounts for more than 4% of direct health-care costs [1‐3].

The American Stroke Association's Task Force on the Development of Stroke Systems outlined that the obstacles in translating scientific advances into clinical practice for stroke are often related to a fragmentation of stroke-related care caused by inadequate integration of facilities and professionals that should closely collaborate in providing stroke care. This potentially contributes to the high morbidity, mortality and economic cost of this disorder [4]. Other studies also suggest that establishing well-organized and multidisciplinary stroke care can help improve the quality of service delivered and reduce stroke mortality rates [5, 6].

According to the Helsingborg Declaration in 2006 on European Stroke Strategies, all patients in Europe with stroke should have access to a continuum of care, from organized stroke units in the acute phase through to appropriate rehabilitation and secondary prevention measures. Consequently to improve the outcome for acute stroke patients, the optimization of the use of multidisciplinary teams, the development of better ways to deliver a continuing stroke education to the professionals and to the public, the implementation of evidence-based stroke care and the evaluation of different models of stroke services were identified as research and development priorities in stroke care from an organizational perspective [7].

A recent review showed that clinical pathways are tools that can help to achieve these goals when applied to stroke care [8]. Clinical pathways are complex interventions for the mutual decision making and organization of care processes for a well-defined group of patients during a well-defined period with the aim of enhancing the quality of care across the continuum by improving risk-adjusted patient outcomes, promoting patient safety, increasing patient satisfaction, and optimizing the use of resources. Their defining characteristics also include an explicit statement of the goals and key elements of care based on evidence, best practice, and patient expectations; the facilitation of communication amongst the team members and with patients and families: the coordination of the care processes by coordinating the 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 [9].

The purpose of the Clinical Pathways for Effective and Appropriate Care Study was to determine whether clinical pathways could improve the quality of the care provided to patients who have been affected by stroke both in hospital and through the continuum of the care.

The aim of this study is to improve the quality of care through clinical pathways and thus should not imply any risk for the patients affected by the study. It is difficult to imagine that interventions based on better evidence and appropriate use of technologies and drugs could worsen the quality of care when compared to usual care. However despite continuing international interest in implementing clinical pathways, the evidence base for their effectiveness in improving the quality of stroke care is still inconclusive [8].

Clinical pathways could be defined as a complex intervention in which a number of separate elements are essential to the functioning of the intervention, but the "active ingredient" that is effective is difficult to specify [11]. For this reason it could be problematic to evaluate properly clinical pathways mainly because of the difficulty of keeping the intervention replicable and recognizable. However we think that a cluster randomized controlled trial design is the most appropriate to evaluate clinical pathways [24]. To standardize the intervention we defined as standard the steps in the change process or the key functions that the elements of the intervention were meant to improve according to each context. Moreover our indicators were driven by the theory and concerned the functions provided by the key elements of the clinical pathways that were based on expected adherence to the same evidences. So we think that this helped to keep the integrity of the intervention in each site [10, 25].

We also think that the outcome measures chosen were well-suited to measuring the impact clinical pathways have on stroke care, because they were measures that evaluated most of the perspectives of stroke care from acute to rehabilitation settings. In particular two outcome measures – mortality and organized care – can help to investigate the new hypothesis which is to understand how clinical pathways can work. In fact the management of patients affected by stroke involves the expertise of several professionals, which can result in poor coordination or inefficiencies in patient treatment, and clinical pathways can significantly improve the outcomes of these patients. However, the active ingredient of clinical pathways is unclear, so we think that our study will help to better understand which mechanisms within the clinical pathways can really improve the quality of care.