(Stroke. 2002;33:643.)
© 2002 American Heart Association, Inc.
Letters to the Editor |
Clinical Trials Research Unit, University of Auckland, Auckland, New Zealand
Clinical Trials Research Unit, University of Auckland, Auckland, New Zealand, and Rehabilitation & Ageing Studies Unit, Department of Medicine, Flinders University of South Australia, Daw Park, South Australia
Rehabilitation & Ageing Studies Unit, Department of Medicine, Flinders University of South Australia, Daw Park, South Australia, and Clinical Epidemiology and Health Outcomes Centre, ACT Health and Community Care
To the Editor:
Stroke is costly to health services and imposes a large burden of death and disability. Given the aging of the population, the care of patients with stroke will have a growing impact on the health care system.1 The more widespread use of stroke units (or teams) or community (home) stroke rehabilitation programs is recognized as an important strategy for improving outcomes and containing costs.1,2
Evidence is accumulating36 supporting the development of services that allow patients with stroke to be sent home from hospital earlier than usual, with appropriate levels of support. In our recently completed trial in Adelaide, South Australia,6,7 for example, we showed that early hospital discharge and home-based stroke rehabilitation can significantly reduce the use of hospital (rehabilitation) beds without compromising patient outcomes. It also highlighted, however, a potential hazard of such schemes, with adverse emotional health outcomes detected among family caregivers at 6 months follow-up. We therefore wished to examine the health outcomes of patients and caregivers over the full 12 months of follow-up.
The methods for this study have been reported previously.6 In summary, 86 patients with acute stroke (first-ever or recurrent), but excluding subarachnoid hemorrhage, who were admitted to the Flinders Medical Center (400 beds) or the Repatriation General Hospital (270 beds) were entered in the trial in 1997 and 1998. All patients were assessed to be medically stable but with some degree of residual disability that required rehabilitation; median time from stroke onset to randomization was 13 days (interquartile range 7 to 21 days). Patients were randomized to receive either "early hospital discharge and home-based rehabilitation and care" (HBC, n=42; 24 with caregivers) or "conventional care" (CC, n=44; 25 with caregivers). Patients randomized to HBC were seen by members of a special multidisciplinary community rehabilitation team who made any necessary adaptations to the patients homes to allow early discharge (most within 72 hours of randomization) and conducted individually tailored therapy sessions (median duration 5 weeks; range 1 to 19 weeks) in the patients homes. Patients randomized to CC received in-hospital rehabilitation, many (66%) within a specialized stroke rehabilitation unit, and had conventional hospital discharge and follow-up. The research ethics committee of each institution approved the study, and written informed consent was obtained from all patients (or from family members when necessary).
Patients and their caregivers (if appropriate) underwent a face-to-face standardized interview before randomization, at baseline, 1, 3, 6, and 12 months after randomization, with a research nurse who was blinded to treatment allocation. The primary outcome measure was health-related quality of life (HRQoL), as assessed by the acute version of the 36-item short-form questionnaire (SF-36)8,9 at 6 months post-randomization. This measure was also assessed at 3 and 12 months post-randomization.
Cross-sectional mean SF-36 scores at 12 months were calculated according to standard guidelines. An a priori power calculation indicated that 34 patients were needed in each group to detect a mean difference of 7 points (SD 10) on the SF-36 summary scores, with 80% power and a 5% level of significance. Area under the curve (AUC)10 analyses were also used to summarize the repeated series of measurements, taking into account the variable timing of observations during follow-up. The AUC SF-36 scores for patients and caregivers were calculated by adding the areas under the curve between each pair of consecutive observations and dividing by 9 (the number of months of follow-up). All analyses were performed using SPSS for Windows, version 10.0.5.11
Of the 86 randomized patients with acute stroke, 2 were lost to follow-up (CC group) and 7 died during follow-up (HBC=3, CC=4), resulting in 77 subjects available for review at 12 months: 39 in the HBC group and 38 in the CC group. There were no significant differences between the groups on average age, gender, medical history, living arrangements, or activity of daily living scores at baseline6 or at 12 months. For the group, ages ranged from 28 to 88 years (mean±SD, 71±11 years, with 3 patients aged under 50), 56% were male, 42% lived alone, and 52% had caregivers.
The Table presents data for patients and caregivers on the SF-36. Cross-sectional and AUC SF-36 mean scores were similar for the 8 domains and the 2 summary scores at 12 months. However, confidence intervals (CI) were wide for all outcomes. The only significant difference between groups occurred in cross-sectional scores for the general health domain with the HBC patients scoring less than CC patients (12-point difference, 95% CI -23.9 to -0.1).
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These data suggest that early hospital discharge and home-based rehabilitation result in broadly similar health outcomes to conventional in-hospital rehabilitation, discharge, and follow-up care for patients and caregivers following acute stroke. Although cross-sectional comparison of caregiver outcome at 6 months indicated poorer mental health in the intervention group,6 the current analyses, both cross-sectionally and taking into account full follow-up data, do not indicate any major adverse effect on caregivers. It is likely that the earlier difference in scores for mental health in caregivers, and now on the general health domain of the SF-36 in patients at 12 months, are chance findings.
A major limitation of this study is that it lacked sufficient power to detect small-to-moderate differences between the 2 groups. Although our finding of no significant differences between patients and caregivers up to 1 year after randomization is consistent with other data,12 previous studies have included small numbers of participants and, therefore, the conclusions should be interpreted with caution. Caregiver outcome, in particular, requires closer attention, as to date there have been few studies with the capacity to relate patient and caregiver characteristics to longer-term caregiver outcome.13
Sue McKechnie and the Ambulatory Care Unit of the South Australian Health Commission supported this project through a grant from the Federal Government.
References
1. National Stroke Foundation. Stroke: national goals, targets and strategies. Melbourne, Australia; 1997.
2.
Stroke Unit Trialists Collaboration. Collaborative systematic review of the randomised trials of organised in-patient (stroke unit) care after stroke. BMJ. 1997; 314: 11511159.
3.
Rudd AG, Wolfe CD, Tilling K, Beech R. Randomised controlled trial to evaluate early discharge scheme for patients with stroke. BMJ. 1997; 315: 10391044.
4.
Beech R, Rudd AG, Tilling K, Wolfe CD. Economic consequences of early inpatient discharge to community-based rehabilitation for stroke in an inner-London teaching hospital. Stroke. 1999; 30: 729735.
5.
Mayo NE, Wood-Dauphinee S, Cote R, Gayton D, Carlton J, Buttery J, Tamblyn R. Theres no place like home: an evaluation of early supported discharge for stroke. Stroke. 2000; 31: 10161023.
6.
Anderson C, Rubenach S, Ni Mhurchu C, Clark M, Spencer C, Winsor A. Home or hospital for stroke rehabilitation? Results of a randomised controlled trial, I: health outcomes at six months. Stroke. 2000; 31: 10241031.
7.
Anderson C, Ni Mhurchu C, Rubenach S, Clark M, Spencer C, Winsor A. Home or hospital for stroke rehabilitation? Results of a randomized controlled trial, II: cost minimization analysis at 6 months. Stroke. 2000; 31: 10321037.
8. Ware JE, Snow KK, Kosinski M, Gandek B. SF-36 Health Survey: manual and interpretation guide. Boston, Mass.: New England Medical Center, Health Institute; 1993.
9. Ware JE. SF-36 Physical and Mental Health Summary Scales. Boston, Massachusetts: The Health Institute, New England Medical Center, 1994.
10. Matthews JNS, Altman DG, Campbell MJ, Royston JP. Analysis of serial measurements in medical research. BMJ. 1990; 300: 230235.
11. SPSS for Windows, Version 10.0.5. Chicago, Ill.: SPSS Inc; 1999.
12.
Gunnell D, Coast J, Richards S, Peters T, Pounsford J, Darlow M. How great a burden does early discharge to hospital-at-home impose on carers? A randomized controlled trial. Age Ageing. 2000; 29: 137142.
13.
Han B, Haley WE. Family caregiving for patients with stroke: review and analysis. Stroke. 1999; 30: 14781485.
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