Evaluating an extended rehabilitation service for stroke patients (EXTRAS): study protocol for a randomised controlled trial.
BACKGROUND
Development 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
This 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.


CONCLUSIONS
The provision of longer term support for stroke survivors is currently limited. The results from this trial will inform future stroke service planning and configuration.


BACKGROUND
This trial was registered with ISRCTN (identifier: ISRCTN45203373 ) on 9 August 2012.
Institute of Neuroscience (Stroke Research Group), Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, England, UK. Helen.Rodgers@newcastle.ac.uk.|Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital, Rake Lane, North Shields, Tyne and Wear, NE29 8NH, England, UK. Helen.Rodgers@newcastle.ac.uk.
Helen
H
Rodgers
Institute of Neuroscience (Stroke Research Group), Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, England, UK. Lisa.Shaw@newcastle.ac.uk.
Lisa
L
Shaw
Lay investigator. Contact via: Institute of Neuroscience (Stroke Research Group), Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, England, UK. Helen.Rodgers@newcastle.ac.uk.
Robin
R
Cant
Division of Rehabilitation and Ageing, University of Nottingham, B Floor, Medical School, Queen's Medical Centre, Nottingham, NG7 2UH, England, UK. Avril.Drummond@nottingham.ac.uk.
Avril
A
Drummond
Oxford Academic Health Science Network, John Eccles House, Robert Robinson Avenue, Oxford Science Business Park, Oxford, OX4 4GP, England, UK. Gary.Ford@ouh.nhs.uk.
Gary A
GA
Ford
Academic Unit of Elderly Care and Rehabilitation, University of Leeds, Bradford Institute for Health, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, England, UK. A.Forster@leeds.ac.uk.
Anne
A
Forster
Institute of Neuroscience (Stroke Research Group), Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, England, UK. Katie_Barrick@hotmail.co.uk.
Katie
K
Hills
Institute of Health and Society, Newcastle University, Baddiley-Clark Building, Richardson Road, Newcastle upon Tyne, NE2 4AX, England, UK. Denise.Howel@newcastle.ac.uk.
Denise
D
Howel
Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, Wansbeck General Hospital, Woodhorn Lane, Ashington, Northumberland, NE63 9JJ, England, UK. Anne-Marie.Laverty@northumbria-healthcare.nhs.uk.
Anne-Marie
AM
Laverty
Department of Public Health Sciences, King's College London, Capital House, 7th Floor, 41 Western Street, London, SE1 3QD, England, UK. Christopher.Mckevitt@kcl.ac.uk.
Christopher
C
McKevitt
Faculty of Health and Life Sciences, Coach Lane Campus, Northumbria University, Newcastle upon Tyne, NE7 7XA, England, UK. Peter.McMeekin@northumbria.ac.uk.
Peter
P
McMeekin
Institute of Neuroscience (Stroke Research Group), Newcastle University, 3-4 Claremont Terrace, Newcastle upon Tyne, NE2 4AE, England, UK. C.I.M.Price@newcastle.ac.uk.|Stroke Northumbria, Northumbria Healthcare NHS Foundation Trust, Wansbeck General Hospital, Woodhorn Lane, Ashington, Northumberland, NE63 9JJ, England, UK. C.I.M.Price@newcastle.ac.uk.
Christopher
C
Price
D000203:Activities of Daily Living; D017028:Caregivers / Q000523:psychology; D002985:Clinical Protocols; D003153:Community Health Services / Q000458:organization & administration*; D003266:Continuity of Patient Care / Q000458:organization & administration*; D006304:Health Status; D006801:Humans; D007407:Interviews as Topic; D010348:Patient Care Team / Q000458:organization & administration; D010351:Patient Discharge; D015397:Program Evaluation; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D018401:Sample Size; D013222:State Medicine; D020521:Stroke / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology; D000071939:Stroke Rehabilitation; D013689:Telephone; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom