Organising Support for Carers of Stroke Survivors (OSCARSS): study protocol for a cluster randomised controlled trial, including health economic analysis
Tóm tắt
Stroke often results in chronic disability, with partners and family members taking on the role of informal caregiver. There is considerable uncertainty regarding how best to identify and address carers’ needs. The Carer Support Needs Assessment Tool (CSNAT) is a carer-led approach to individualised assessment and support for caregiving that may be beneficial in palliative care contexts. CSNAT includes an implementation toolkit. Through collaboration, including with service users, we adapted CSNAT for stroke and for use in a UK stroke specialist organisation providing long-term support. The main aims of OSCARSS are to investigate the clinical and cost-effectiveness of CSNAT-Stroke relative to current practice. This paper focuses on the trial protocol, with the embedded process evaluation reported separately. Longitudinal, multi-site, pragmatic, cluster randomised controlled trial with a health economic analysis. Clusters are UK services randomised to CSNAT-Stroke intervention or usual care, stratified by size of service. Eligible carer participants are: adults aged > 18 years; able to communicate in English; referred to participating clusters; and seen face-to-face at least once by the provider, for support. The ‘date seen’ for initial support denotes the start of intervention (or control) and carers are referred to the research team after this for study recruitment. Primary outcome is caregiver strain (FACQ - Strain) at three months after ‘date seen’. Secondary outcomes include: caregiver distress; positive caregiving appraisals (both FACQ subscales); Pound Carer Satisfaction with Services; mood (HADs); and health (EQ-5D5L) at three months. All outcomes are followed up at six months. Health economic analyses will use additional data on caregiver health service utilisation and informal care provision. OSCARSS is open to recruitment at the time of article submission. Study findings will allow us to evaluate the clinical and cost-effectiveness of the CSNAT-Stroke intervention, directed at improving outcomes for informal carers of stroke survivors. Trial findings will be interpreted in the context of our embedded process evaluation including qualitative interviews with those who received and provided services as well as data on treatment fidelity. OSCARSS will contribute to knowledge of the unmet needs of informal stroke caregivers and inform future stroke service development. ISRCTN Registry,
ISRCTN58414120
. Registered on 26 July 2016.
Tài liệu tham khảo
Adamson J, Beswick A, Ebrahim S. Is stroke the most common cause of disability? J Stroke Cerebrovasc Dis. 2004;13(4):171–7.
McKevitt C, Redfern J, Mold F, Wolfe C. Qualitative studies of stroke: a systematic review. Stroke. 2004;35(6):1499–505.
Patchick EL, Horne M, Woodward-Nutt K, Vail A, Bowen A. Development of a patient-centred, patient-reported outcome measure (PROM) for post-stroke cognitive rehabilitation: qualitative interviews with stroke survivors to inform design and content. Health Expect. 2015;18:2313–24.
Luengo-Fernandez R, Leal J, Gray A, Petersen S, Rayner M. Cost of cardiovascular diseases in the United Kingdom. Heart. 2006;92(10):1384–9.
Saka O, McGuire A, Wolfe C. Cost of stroke in the United Kingdom. Age Ageing. 2009;38(1):27–32.
Draper P, Brocklehurst H. The impact of stroke on the well-being of the patient's spouse: an exploratory study. J Clin Nurs. 2007;16(2):264–71.
Godwin KM, Ostwald SK, Cron SG, Wasserman J. Long-term health-related quality of life of stroke survivors and their spousal caregivers. J Neurosci Nurs. 2013;45(3):147–54.
Byun E, Evans LK. Concept analysis of burden in caregivers of stroke survivors during the early poststroke period. Clin Nurs Res. 2015;24(5):468–86.
Haley WE, Roth DL, Hovater M, Clay OJ. Long-term impact of stroke on family caregiver well-being: a population-based case-control study. Neurology. 2015;84(13):1323–9.
Royal College of General Practitioners. RCGP Commissioning for Carers. London: RCGP; 2013. Available: http://www.rcgp.org.uk/clinical-and-research/clinical-resources/~/media/6C9C69A8CF64490594E464F6E611CC42.ashx. Accessed 27 Apr 2018.
Department of Health. Care Act. London: Department of Health; 2014. Available: http://www.legislation.gov.uk/ukpga/2014/23/contents/enacted/data.htm. Accessed 27 Apr 2018.
Medical Directorate and Nursing Directorate. NHS England’s Commitment for Carers. Leeds: NHS England; 2014. Available: http://www.england.nhs.uk/wp-content/uploads/2014/05/commitment-to-carers-may14.pdf. Accessed 27 Apr 2018.
Ellis G, Mant J, Langhorne P, Dennis M, Winner S. Stroke liaison workers for stroke patients and carers: an individual patient data meta-analysis. Cochrane Database Syst Rev. 2010;5:CD005066. https://doi.org/10.1002/14651858.CD005066.pub2.
Legg L, Quinn TJ, Mahmood F, Weir CJ, Tierney J, Stott DJ, et al. Non-pharmacological interventions for caregivers of stroke survivors. Cochrane Database Syst Rev. 2011;10:CD008179. https://doi.org/10.1002/14651858.CD008179.pub2.
Forster A, Brown L, Smith J, House A, Knapp P, Wright JJ, et al. Information provision for stroke patients and their caregivers. Cochrane Database Syst Rev. 2012;11:CD001919. https://doi.org/10.1002/14651858.CD001919.pub3.
Sorensen S, Pinquart M, Duberstein P. How effective are interventions with caregivers? An updated meta-analysis. Gerontologist. 2002;42(3):356–72.
Cameron JI, Gignac MA. “Timing It Right”: a conceptual framework for addressing the support needs of family caregivers to stroke survivors from the hospital to the home. Patient Educ Couns. 2008;70(3):305–14.
Ewing G, Grande G, National Association for Hospice at Home. Development of a Carer Support Needs Assessment Tool (CSNAT) for end-of-life care practice at home: a qualitative study. Palliat Med. 2013;27(3):244–56.
Aoun SM, Grande G, Howting D, Deas K, Toye C, Troeung L, et al. The impact of the carer support needs assessment tool (CSNAT) in community palliative care using a stepped wedge cluster trial. PLoS One. 2015;10(4):e0123012.
Grande GE, Austin L, Ewing G, O’Leary N, Roberts C. Assessing the impact of a Carer Support Needs Assessment Tool (CSNAT) intervention in palliative home care: a stepped wedge cluster trial. BMJ Support Palliat Care. 2017;7:326–34.
Aoun S, Deas K, Toye C, Ewing G, Grande G, Stajduhar K. Supporting family caregivers to identify their own needs in end-of-life care: Qualitative findings from a stepped wedge cluster trial. Palliat Med. 2015;29(6):508–17.
Ewing G, Austin L, Grande G. The role of the Carer Support Needs Assessment Tool in palliative home care: A qualitative study of practitioners’ perspectives of its impact and mechanisms of action. Palliat Med. 2016;30(4):392–400.
Cooper B, Kinsella GJ, Picton C. Development and initial validation of a family appraisal of caregiving questionnaire for palliative care. Psychooncology. 2006;15(7):613–22.
Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36.
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67(6):361–70.
Pound P, Gompertz P, Ebrahim S. Development and results of a questionnaire to measure carer satisfaction after stroke. J Epidemiol Community Health. 1993;47(6):500–5.
Forster A, Dickerson J, Young J, Patel A, Kalra L, Nixon J, et al. A structured training programme for caregivers of inpatients after stroke (TRACS): a cluster randomised controlled trial and cost-effectiveness analysis. Lancet. 2013;382(9910):2069–76.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, et al. Better Reporting of Interventions: Template for Intervention Description and Replication (TIDieR) Checklist and Guide. Gesundheitswesen. 2016;78(3):175–88.
Royston P. Multiple imputation of missing values: update of ice. Stata J. 2005;5(4):527.
Campbell MK, Piaggio G, Elbourne DR, Altman DG, CONSORT Group. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349–57.