(Stroke. 2000;31:1024.)
© 2000 American Heart Association, Inc.
Original Contributions |
Home or Hospital for Stroke Rehabilitation? Results of a Randomized Controlled Trial
I: Health Outcomes at 6 Months
From the Rehabilitation and Ageing Studies Unit, Department of Medicine, Flinders University of South Australia, Daw Park, South Australia (C.A., S.R., M.C.); the Clinical Trials Research Unit, Department of Medicine, University of Auckland, Auckland, New Zealand (C.A., C.N.M.); and the Southern Domiciliary Care and Rehabilitation Service, Adelaide, South Australia (C.S., A.W.).
Correspondence to Professor Craig Anderson, Department of Medicine, University of Auckland, Private Bag 92019, Auckland, New Zealand. E-mail c.anderson{at}ctru.auckland.ac.nz
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Abstract |
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Background and Purpose—We wished to examine the effectiveness of an early hospital discharge and home-based rehabilitation scheme for patients with acute stroke.
Methods—This was a randomized, controlled trial comparing early hospital discharge and home-based rehabilitation with usual inpatient rehabilitation and follow-up care. The trial was carried out in 2 affiliated teaching hospitals in Adelaide, South Australia. Participants were 86 patients with acute stroke (mean age, 75 years) who were admitted to hospital and required rehabilitation. Forty-two patients received early hospital discharge and home-based rehabilitation (median duration, 5 weeks), and 44 patients continued with conventional rehabilitation care after randomization. The primary end point was self-reported general health status (SF-36) at 6 months after randomization. A variety of secondary outcome measures were also assessed.
Results—Overall, clinical outcomes for patients did not differ significantly between the groups at 6 months after randomization, but the total duration of hospital stay in the experimental group was significantly reduced (15 versus 30 days; P<0.001). Caregivers among the home-based rehabilitation group had significantly lower mental health SF-36 scores (mean difference, 7 points).
Conclusions—A policy of early hospital discharge and home-based rehabilitation for patients with stroke can reduce the use of hospital rehabilitation beds without compromising clinical patient outcomes. However, there is a potential risk of poorer mental health on the part of caregivers. The choice of this management strategy may therefore depend on convenience and costs but also on further evaluations of the impact of stroke on caregivers.
Key Words: caregivers • neuropsychological tests • randomized controlled trials • rehabilitation • stroke management
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Introduction |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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Stroke, with its attendant major mortality and morbidity rates, is a significant healthcare problem in many countries.1 2 Given increasing demand on health services in aging populations, it is crucial that clinicians, consumers, and policy makers evaluate the most effective, efficient, and acceptable methods of managing patients with stroke.3 In most developed countries, there is a heavy reliance on hospitals for the acute care and rehabilitation of patients with stroke, whereas the promotion of community services for these purposes is limited.4 5 A strong argument in favor of admission to hospital after the onset of stroke is the potential benefit for some patients of rapid access to an accurate diagnosis and immediate treatments6 7 and nursing care and multidisciplinary rehabilitation, which are often more readily available in hospital than at home.
There are, however, disadvantages to the emphasis on hospital services for stroke. Although inpatient care and rehabilitation may meet important clinical, physical, and psychosocial needs during the early crisis of stroke, the needs of patients and family caregivers as they evolve in the longer term may not be addressed in hospital.8 9 Another issue is that the impact of stroke is perceived too much in terms of physical disability, and the long-term psychosocial aspects of stroke, including effects on caregivers,10 11 are often overlooked by healthcare professionals.9 Finally, admission to hospital is a major translocation for many patients, particularly those who are elderly and disabled, and inpatient rehabilitation may foster states of depression and learned dependency that are detrimental to long-term outcome.12 13
Advocates of home-based stroke rehabilitation suggest several advantages: satisfying patient choice, reducing the risks associated with inpatient care through reductions in length of hospital stay, the home setting being more focused toward rehabilitation outcomes, and savings in direct costs.3 8 We wished to evaluate the effectiveness of this new model of early hospital discharge and home-based rehabilitation for patients with acute stroke. We postulated that the program would facilitate reintegration into the community and thereby improve health-related quality of life for patients and caregivers. The costs and resource implications of this policy were also investigated.
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Subjects and Methods |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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Subjects
All patients with a clinical diagnosis of stroke (first-ever or recurrent), but excluding subarachnoid hemorrhage, who were admitted to the Flinders Medical Center (400 beds) or Repatriation General Hospital (270 beds) between February 1997 and June 1998 were assessed for participation in the trial. These are 2 affiliated acute-care public teaching hospitals serving a population of 340 000 in the southern metropolitan region of Adelaide, South Australia. All patients with stroke and residual disability who were assessed by the attending medical team as requiring rehabilitation were eligible for the trial according to the following criteria: (1) their hospital consultant agreed that they were medically stable and suitable to be discharged early from hospital to a community rehabilitation scheme, (2) they had sufficient physical and cognitive function for "active" participation in the rehabilitation scheme, (3) their home environment was suitable for simple modifications, (4) the community rehabilitation team was available to provide care, (5) they had a general practitioner who was willing to provide any necessary medical care, and (6) their caregiver (if one was identified) gave consent for participation.
The study was approved by the research ethics committee at each institution, and written informed consent was obtained from all patients.
Intervention
A community rehabilitation team was formed that comprised a
full-time program coordinator (an occupational therapist); a
consultant in rehabilitation; and physiotherapists,
occupational therapists, social workers, speech therapists, and
rehabilitation nurses most of whom had experience in community
therapy. Their time was contracted by the service according to
workload. The role of the coordinator involved development of new
interdisciplinary communication systems, close liaison with staff on
acute medical and rehabilitation wards to identify potential patients,
confirmation of the eligibility of patients, collection of consent and
baseline data, setting of each individual patient’s rehabilitation
goals, organization of all necessary modifications to patients’ homes,
and coordination of input from therapists and other staff.
For patients randomized to the intervention program, efforts were made for any adaptations to the home, therapy, and other care to be organized so that discharge from hospital could occur within 48 hours of randomization. Therapy sessions were conducted in the patient’s home and were individually tailored, with the aim of achieving a set of mutually agreed-upon goals over several weeks. Emphasis was placed on self-learning and adjustment to disability, and structured practice sessions were encouraged between visits. The community rehabilitation team met weekly to discuss each individual patient’s progress while on the program. Patients were reviewed separately by the coordinator and the consultant at the time of discharge from the program and were referred to any community agencies for ongoing care as required.
Patients randomized to the control group received conventional care and rehabilitation in hospital, either on an acute-care medical/geriatric ward or in a multidisciplinary stroke rehabilitation unit run by specialists in rehabilitation or geriatric medicine. For these patients, care pathways were used, and discharge planning and follow-up care as an outpatient or in the community was organized according to usual policy.
Baseline Assessment
The coordinator collected baseline data before randomization.
This included sociodemographic information, clinical features of the
current stroke, medical history and risk factors for stroke, details of
physical functioning, and use of community services in the premorbid
period. The modified Barthel Index14 was used to assess
the patient’s level of activities of daily living (ADL), and the
Mini-Mental State Examination15 and 28-item General Health
Questionnaire (GHQ-28)16 were used to assess cognition and
emotional state, respectively. The Adelaide Activities Profile
(AAP)17 and the General Functioning Subscale of the
McMaster Family Assessment Device (MFAD)18 were each
administered to patients and caregivers to assess their premorbid
levels of "non-ADL" activities and family dynamics, respectively.
The AAP is a relatively new instrument that was developed from the
Frenchay Activities Index19 for the measurement of
activities that focus on the lifestyles of older people across 4
domains: domestic chores, household maintenance, service to
others, and social activities.
Randomization
Patients were randomized to a treatment allocation once consent
and baseline assessments were complete. The hospital pharmacy
department was contacted by telephone for the allocation sequence,
which was computer-generated and maintained in sealed opaque envelopes.
No stratification was performed.
Follow-Up
All patients (and their caregivers) were followed up at 1, 3, 6,
and 12 months after randomization. At each of these assessments,
patients underwent a face-to-face standardized interview in their own
home with a research nurse who was independent of the rehabilitation
team and unaware of treatment allocation. The main outcome measure used
was health-related quality of life as assessed by the 36-item
short-form questionnaire (SF-36),20 21 which was
administered to patients and caregivers. Assessments were also made of
the patient’s general health by use of the Nottingham Health
Profile,22 as well as of physical function, social
activities, family dynamics, emotional state, and general health by use
of the same instruments as were used at baseline. In addition, the
MFAD, AAP, GHQ-28, and the Caregiver Strain Index23 were
administered to caregivers. Finally, the use of community services,
readmissions to hospital, history of falls, place of residence, and
patient and caregiver satisfaction with their medical care,
rehabilitation, and recovery were assessed with questionnaires
developed for the study. Outcomes at 6 months are presented
here.
Statistical Analysis
Data were analyzed on the basis of intention to treat.
Continuous variables that were approximately normally distributed
were compared by independent sample t tests, and mean
differences were expressed with 95% CIs. When the continuous
variables showed evidence of nonnormal distribution, the
Mann-Whitney U test was used to compare continuous
data and 95% CIs calculated for the median difference. Categorical
variables were compared by the 
2 test. The
analyses had 80% power to detect a 7-point difference on the
physical and mental health summary of the SF-36 (assuming an SD of 10).
This difference has been shown to reflect impairment associated with a
limitation in the use of an arm or leg.21 This
required a total sample size of 65, but the final number of patients
recruited was 86, to take into account a predicted dropout rate of
20%. All analyses were performed with SPSS for
Windows24 and Confidence Interval
Analysis25 software.
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Results |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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In all, 398 patients with acute stroke were screened for eligibility for the trial between February 1996 and June 1998. The Figure
shows the flow of patients through
the trial. Of these 398 patients, 132 (42%) were assessed to have made
a good recovery from stroke and were discharged home, 70 (22%) had
severe disability and were discharged to a residential or nursing home,
5 (2%) had already lived or had moved out of the area, 79 (25%) died,
and 26 (8%) refused to participate in the trial. The remaining 86
patients with residual disability were randomly allocated to treatment,
42 to early hospital discharge and home-based rehabilitation and 44 to
conventional hospital and community care.
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Table 1 shows the baseline
characteristics of the intervention and control patients. More patients
in the intervention group had a history of hypertension, but otherwise
the sociodemographic, clinical, and functional characteristics of the
study groups were similar at baseline. The mean age of the entire group
was 75 years, with 56% being male and 57% having an identified
partner or other caregiver.
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The duration of the home-based intervention varied according to the individual needs of the patient. However, the median duration of home-based rehabilitation was 5 weeks (range, 1 to 19 weeks). All randomized patients were accounted for at the end of the study. Two patients in the intervention group died between 3 and 6 months of a recurrent stroke (at 14 weeks) and cardiac failure (at 18 weeks), respectively. Otherwise, follow-up was complete.
Table 2 shows information on the use of
healthcare utilization during follow-up. Length of stay after
randomization in the intervention group was significantly reduced (2
versus 11.5 days; P<0.001), so that the mean total time of
initial hospital admission of 15 days in the intervention group was
considerably shorter than that of 30 days in the control group (95% CI
for difference, 6 to 22 days). No other significant differences between
the 2 groups were found in the frequencies of readmission to hospital,
use of community services, and admissions to residential care at the
end of follow-up.
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Table 3 describes the health outcomes for
patients at 6 months. No significant differences between the 2 groups
were found on any of the measures, including the domains of the SF-36,
Nottingham Health Profile, and AAP. In both groups, most
patients were satisfied with their recovery and input from services,
but there was also consistency between groups in that the
lowest levels of satisfaction were related to their understanding about
stroke and the information they had received from healthcare
professionals during the course of rehabilitation.
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Among caregivers, however, there were some differences in health
outcomes. Table 4 shows that caregivers
of patients in the intervention group had lower general mental health
(70 versus 82; P=0.01) and mental component scores (47
versus 57; P=0.07) of the SF-36. Moreover, caregivers were
less active in household maintenance activities according to
the AAP (P=0.05) compared with caregivers in the control
group. Caregiver satisfaction did not differ between the groups.
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Discussion |
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TopAbstractIntroductionSubjects and MethodsResultsDiscussionReferences |
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This randomized, controlled trial of accelerated hospital discharge and home-based stroke rehabilitation examined a broad spectrum of outcomes ranging from substantive outcomes, such as death and readmissions to hospital, to more subjective outcomes, such as health-related quality of life and satisfaction with health care. Although patients in the intervention group received multidisciplinary home-based rehabilitation that was specifically targeted toward their individual needs, the program had no significant impact on their general health or physical or psychological outcomes that was different from that of conventional care. However, the program did achieve early discharge from hospital and a marked reduction in total length of stay. There is some evidence, however, that the program may have had an adverse impact on caregivers.
The finding of worse general mental health among caregivers in the
intervention group is important, because there is little information
about the impact of such schemes on the health and well-being of
caregivers in previous studies of early discharge and home-based
rehabilitation for patients with stroke. Although a
"problem-solving" approach was used by the community rehabilitation
team, it is possible that the observed trend of lower SF-36 mental
health and mental component scores in caregivers in the intervention
group may have occurred because the model of care focused on recovery
for patients. If this is so, future accelerated discharge interventions
for patients with stroke may benefit from increased focus on emotional
support for caregivers and specific goal setting related to their own
needs.26 27 However, caution is needed in interpreting
this result, because the sample size is small. In particular, these
data relate to only 50% of the patient group who had a caregiver,
and the large number of outcomes analyzed means that there is a
possibility that a significant result occurred purely as a result of
chance, resulting in a type I error. In addition, the process of
consent to randomization might have biased the results, because some
patients (and caregivers) might have been disappointed at being
allocated to the control group,28 although if there was
bias, the expected direction of response would be for caregivers in the
control group to have worse scores than those in the intervention
group, but there was no such significant trend.
However, even if the observed significant difference between groups of caregivers is valid, there are certain issues about the SF-36 that are worth considering. The general mental health scale is a bipolar scale, with a midrange score earned by those reporting no symptoms of psychological distress. The high mean scores obtained by the caregivers in both groups (70 and 82) indicate a good level of mental health overall.21 In addition, the mental health scale norm for the general population of South Australia is 79,29 which again compares quite well with the scores obtained by the caregivers in both groups. Thus, it would seem that although there may be a difference in mental health scores between the groups of caregivers, their general mental health is not generally poor and, in fact, compares well with that of the South Australia population as a whole.
The 86 patients who participated in this study represented only 22% of all patients with stroke admitted to hospital over the study period. Unfortunately, no data are available to compare the trial patients with those who were excluded or refused to partake in the study. However, of the 312 hospitalized stroke patients who were not randomized, only 26 eligible patients declined to participate in the study, and the remainder were ineligible because of their health status or place of residence. Thus, the proportion of randomized patients probably compares well with patients allocated to rehabilitation services in everyday clinical practice.
Evidence of effectiveness of home-based stroke rehabilitation is
available from several randomized controlled trials conducted over the
past decade.30 31 32 33 34 35 These trials have been undertaken among
patients with stroke who have received either
conventional30 31 32 or early discharge from
hospital.33 34 35 All have concluded that home-based
rehabilitation after stroke is feasible, acceptable to patients (and
caregivers), and as effective as routine care and
rehabilitation.36 37 This study confirms that such a
program can considerably shorten the length of stay in hospital, by
1 to 2 weeks on average, without compromising patient safety or
functional outcomes for survivors of stroke. Of course, apart from the
study involving 331 participants in London,37 these
studies of early discharge and home-based rehabilitation have all been
relatively small (<100 participants), so there might be modest
benefits (or risks) that would be evident only in a larger trial or
from a systematic overview of all trials.38
In conclusion, accelerated hospital discharge and home-based rehabilitation in Adelaide proved to be a practical and effective alternative to conventional care for patients with stroke and resulted in a significant reduction in length of hospital stay. This reduction in length of stay may make home-based rehabilitation an attractive and cost-effective means of rehabilitating some patients with stroke in the Australian setting. However, further detailed investigation of the cost implications of such rehabilitation schemes is needed before they can be adopted unreservedly. The cost-minimization analysis of this randomized, controlled trial is reported in the accompanying article.
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Acknowledgments |
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We are grateful to Sue McKechnie and the Ambulatory Care Unit of the South Australian Health Commission, who supported this project through a grant from the Federal Government. We are indebted to the following members of the community rehabilitation team for their dedication: Robyn Lister and Nicki Hayball (consecutive project coordinators), Heather Jesshope, Jan Van Emden, Penny Jacomos, Naomi Brill, Marion Reece, John Stanfield, Robyn Burnett, Belinda Magor, Edwina Reid, Martine Ledger, Colleen Gleeson, Helen Reid, Marline Reece, Margi Smart, Donna Lawrence, Claire Morris, and Beth Stronach. We thank Sara Laubscher and Kerry Clifford for their support in the study and Derrick Bennett and Paul Brown of the University of Auckland for their advice on statistical and economic analyses. The authors acknowledge the support of the following people: M. Bennett, A. Crockett, A. Darzins, B. Dodd, P. Finucane, J. Harvey, E. Hobbin, P. Lavelle, D. Law, M. McTab, M. Russell, H. Trenorden, L. White, and B. Wilson and our colleagues and staff at the Flinders Medical Centre, Repatriation General Hospital, and Southern Domiciliary Care and Rehabilitation Service, South Australia.
Received November 9, 1999; revision received February 16, 2000; accepted February 24, 2000.
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 C Pozzilli, M Brunetti, A M V Amicosante, C Gasperini, G Ristori, L Palmisano, and M Battaglia Home based management in multiple sclerosis: results of a randomised controlled trial J. Neurol. Neurosurg. Psychiatry, September 1, 2002; 73(3): 250 - 255. [Abstract] [Full Text] [PDF]
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M. L. Hackett, A. C. Vandal, C. S. Anderson, and S. E. Rubenach Long-Term Outcome in Stroke Patients and Caregivers Following Accelerated Hospital Discharge and Home-Based Rehabilitation Stroke, February 1, 2002; 33(2): 643 - 645. [Full Text] [PDF]
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J. M. Geddes and M A. Chamberlain Home-based rehabilitation for people with stroke: a comparative study of six community services providing co-ordinated, multidisciplinary treatment Clinical Rehabilitation, June 1, 2001; 15(6): 589 - 599. [Abstract] [PDF]
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B. Indredavik, H. Fjartoft, G. Ekeberg, A. D. Loge, and B. Morch Benefit of an Extended Stroke Unit Service With Early Supported Discharge : A Randomized, Controlled Trial Stroke, December 1, 2000; 31(12): 2989 - 2994. [Abstract] [Full Text] [PDF]
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P. Griffiths Early discharge plus home based rehabilitation reduced length of initial hospital stay but did not improve health related quality of life in patients with acute stroke Evid. Based Nurs., October 1, 2000; 3(4): 127 - 127. [Full Text]
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 Is Home-Based Stroke Rehabilitation Effective? Journal Watch Neurology, September 6, 2000; 2000(906): 4 - 4. [Full Text]
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