Abstract
BackgroundDevelopment of longer term stroke rehabilitation services is limited by lack of evidence of effectiveness for specific interventions and service models. We describe the protocol for a multicentre randomised controlled trial which is evaluating an extended stroke rehabilitation service. The extended service commences when routine ‘organised stroke care’ (stroke unit and early supported discharge (ESD)) ends.Methods/designThis study is a multicentre randomised controlled trial with health economic and process evaluations. It is set within NHS stroke services which provide ESD. Participants are adults who have experienced a new stroke (and carer if appropriate), discharged from hospital under the care of an ESD team.The intervention group receives an extended stroke rehabilitation service provided for 18 months following completion of ESD. The extended rehabilitation service involves regular contact with a senior ESD team member who leads and coordinates further rehabilitation. Contact is usually by telephone. The control group receives usual stroke care post-ESD. Usual care may involve referral of patients to a range of rehabilitation services upon completion of ESD in accordance with local clinical practice. Randomisation is via a central independent web-based service.The primary outcome is extended activities of daily living (Nottingham Extended Activities of Daily Living Scale) at 24 months post-randomisation. Secondary outcomes (at 12 and 24 months post-randomisation) are health status, quality of life, mood and experience of services for patients, and quality of life, experience of services and carer stress for carers. Resource use and adverse events are also collected. Outcomes are undertaken by a blinded assessor.Implementation and delivery of the extended stroke rehabilitation service will also be described. Semi-structured interviews will be conducted with a subsample of participants and staff to gain insight into perceptions and experiences of rehabilitation services delivered or received.Allowing for 25% attrition, 510 participants are needed to provide 90% power to detect a difference in mean Nottingham Extended Activities of Daily Living Scale score of 6 with a 5% significance level.DiscussionThe provision of longer term support for stroke survivors is currently limited. The results from this trial will inform future stroke service planning and configuration.Trial registrationThis trial was registered with ISRCTN (identifier: ISRCTN45203373) on 9 August 2012.
Highlights
Development of longer term stroke rehabilitation services is limited by lack of evidence of effectiveness for specific interventions and service models
Stroke patients and their informal carers are frequently disappointed and frustrated that longer term rehabilitation is not more widely available, and the United Kingdom (UK) Stroke Survivor Needs Survey reported that nearly half of stroke survivors experience unmet needs in the longer term [2]
Unable to participate in a rehabilitation programme which focuses upon extended activities of daily living (EADL)
Summary
Development of longer term stroke rehabilitation services is limited by lack of evidence of effectiveness for specific interventions and service models. The extended service commences when routine ‘organised stroke care’ (stroke unit and early supported discharge (ESD)) ends. Input from a therapist or nurse with specialist expertise in stroke rehabilitation is rare beyond 6 months post-discharge. Stroke units and early supported discharge (ESD) services are effective ways to improve patient outcomes and the quality of care following stroke [3,4]. These services are referred to as ‘organised stroke care’, and their key features are multidisciplinary stroke specialist expertise and coordination of care [5,6]. Therapybased rehabilitation services for stroke patients at home provided soon after discharge have been shown to be effective [9]
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