Early supported discharge of patients with acutestroke: a randomized controlled trial

E. BAUTZ-HOLTER{*, U. SVEEN{, J. RYGH{, H. RODGERS}and T. BRUUN WYLLER}

{ Department of Physical Medicine and Rehabilitation, Ullevaal Hospital, Kirkeveien 166,0407 Oslo, Norway

{ County Health Office, PB 8041 DE, N-0031 Oslo, Norway} Centre for Health Services Research, University of Newcastle upon Tyne, 21 Claremont

Place, Newcastle upon Tyne NE2 7AA, UK

} Aker Hospital, Trondheimsv. 235, N-0514 Oslo, Norway

Accepted for publication: August 2001

Abstract

Purpose: To evaluate the feasibility and effectiveness of earlysupported discharge (ESD) following acute stroke.Method: An ESD scheme was compared to conventionalrehabilitation in a randomized controlled trial. All patientsadmitted with acute stroke were considered for inclusion.Eighty-eight (20.2%) were found to be eligible and 82 wererandomized either to early supported discharge (n=42) orconventional rehabilitation (n=40). The primary outcomemeasure was the Nottingham Extended Activities of DailyLiving Scale. The General Health Questionnaire, theMontgomery Aasberg Depression Rating Scale, mortality,placement and patient and carer satisfaction served assecondary outcome measures.Results: Median length of stay was reduced from 31 days in theconventional hospital rehabilitation group to 22 days in the earlysupported discharge group (p=0.09). No differences were foundregarding primary outcome. The General Health Questionnairescore showed a significant difference in favour of the earlysupported discharge group at three months (19.5/24, p=0.02),but not at six. At six months, the proportion of patients beingdead or in institution showed a trend of being higher in theconventional rehabilitation group (OR 3.8, 95 % CI 0.8 ± 23).Conclusions: Early supported discharge after stroke is feasibleand it is possible that it has benefits compared withconventional rehabilitation.

Introduction

A well-organized in-patient service, based onadequate medical treatment and rehabilitative measures,

is favourable to the outcome of stroke patients.1±5

However, the optimum location for ongoing rehabilita-tion after the initial acute phase is unclear. It is notknown whether stroke patients should have more oftheir rehabilitation provided at home. It is likely thatthe physical and social environment at home creates abetter arena, if care and appropriate rehabilitativemeasures are adequate.6±12 Domiciliary rehabilitationmay provide better conditions for relearning skills andinvolve patients and carers more fully in the decisionmaking, as well as contributing to increased insightand motivation. On the other hand, returning homeearly may be perceived as di� cult and even dangerousby both patients and relatives, and lead to increasedstress, particularly for carers. In addition, domiciliaryrehabilitation may be less intensive and co-ordinatedthan rehabilitation in hospital.

Six randomized controlled trials evaluating an earlysupported discharge (ESD) service for stroke patientshave been conducted.13±18 They indicated that ESDservice was equal to13±16 or better than17, 18 conventionalrehabilitation service (CRS) concerning functionaloutcome. However, one study showed increased stressamong carers.17 Another study, carried out in Akershus,Norway,19 indicated that conventional hospital rehabili-tation was superior to early discharge. However, in thisstudy, no enhanced support was given to the earlydischarge group. Given the wide variation in provisionof health services, it is important to test the ESD strat-egy in diVerent settings and stroke populations. InNorway, for instance, current organization does notallow rehabilitation after discharge to be provided byan outreach team from the hospital like in some other

* Author for correspondence;e-mail: erik.bautz-holter@ioks.uio.no

DISABILITY AND REHABILITATION, 2002; VOL. 24, NO. 7, 348 ± 355

Disability and Rehabilitation ISSN 0963±8288 print/ISSN 1464±5165 online # 2002 Taylor & Francis Ltdhttp://www.tandf.co.uk/journals

DOI: 10.1080/0963828011009367 7

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ESD studies,13±17 but has to be taken care of by primaryhealth care.

A group of ESD trialists has been formed and preli-minary meta-analysis of four studies13±15, 18 showed atrend regarding death and dependency in favour ofESD.20 However, owing to small numbers of study parti-cipants the results are not conclusive, and there is anobvious need for further research to clarify the bene®tsor otherwise of ESD following acute stroke.

The aim of the present study was to test the feasibilityand eVectiveness of an early supported discharge schemefor stroke patients. The results are also expected tocontribute to a further meta-analysis by the group ofESD trialists.

Subjects and methods

PROTOCOL

The study was conducted as a prospective, single-blind, randomized, controlled trial where an ESD groupwas compared with a group receiving CRS. Patientswere recruited from June 1997 to January 1999. Theparticipants were evaluated at baseline and three andsix months after stroke.

All patients with acute stroke (onset less than six daysprior to hospitalization) admitted to the acute strokeunit of Ullevaal hospital were assessed. Ullevaal is auniversity hospital which also serves a local populationof 185 000. Those admitted to medical departmentsother than the stroke unit were not considered becausediVerences in the initial treatment was believed poten-tially to bias the results.1 Patients were eligible to parti-cipate in the study if they were home-dwelling and werenot severely disabled prior to the stroke (Oxford Handi-cap Scale score 0 ± 3),21 had no other medical conditionlikely to preclude rehabilitation and were medicallystable with a Barthel ADL Index score between 5 and19 at 72 h after stroke.22 Patients with subarachnoidhaemorrhage and patients considered unable to consentowing to mental or communication problems wereexcluded.

ASSIGNMENT

Consent was obtained in a two-step fashion accordingto Zelen’s method.23 Consent to collect data was initiallysought from all eligible patients within 72 h of stroke.Those who agreed were randomized to ESD or CRS.The former group was informed about the content ofthe ESD scheme and ®nal consent for participationwas then sought. The study was approved by The Regio-

nal Committee for Ethics of Medical Research. Shortlyafter the study was initiated, the ethics of not giving allinformation about the consequences of agreeing toparticipation in step one was questioned.24 Therefore,the procedure was altered and the participants wereinitially informed about all the possible consequencesof the ®rst consent. However, further consent was stillsought for those randomized to ESD.

The patients were strati®ed by continence of urine at72 h after stroke because of its in¯uence on strokeoutcome25±27 and block-randomized (block-size of four)by computer-generated random numbers into ESD orCSR. The treatment allocation was kept in sealed envel-opes which were subsequently opened once a newsubject was included.

PROVISION OF SERVICES

All participants were initially cared for in an acutestroke unit. After a short stay (3 ± 12 days), the patientsin both groups were, according to clinical condition andneeds, either discharged or transferred to the strokerehabilitation unit. This unit was organized with amultidisciplinary staV (doctor, nurse, occupationaltherapist, physiotherapist , speech therapist and socialworker) specially trained for treating stroke patients.The staV had regular meetings and based their workon an individual rehabilitation scheme, implying acommon strategy for achieving the goals, taking intoconsideration the wishes of the stroke patient. Bothstudy groups had access to the same kind and amountof rehabilitation services during their hospital stay.

Shortly after randomization, the ESD patients wereassessed by a hospital-based multidisciplinary projectteam consisting of a nurse, an occupational therapistand a physiotherapist . One of the three team membersserved as the primary contact for the patients and theirrelatives throughout the study period. In co-operationwith the ordinary hospital staV, the primary contactstarted immediate preparations for the discharge andco-ordination of the continued rehabilitation, whichwas provided by the general community services orga-nized in 11 diVerent local areas. In principle, the samecommunity rehabilitation services were available to theESD and CRS patients, but the staV caring for the ®rstgroup was encouraged to establish a multidisciplinaryteam for each stroke patient and they were oVeredsupport and supervision from the project team wheneverneeded. The control group received the conventionalprocedures for discharge and continued rehabilitation,which were anticipated to be less well organized. Therehabilitative measures were able to be continued as

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long as considered necessary in both randomizationgroups. Four weeks after discharge, the patients in theESD group were seen at the outpatient clinic. They werealso oVered the opportunity to make new contact withthe outpatient clinic if they wished to or to be re-admitted to the hospital whenever needed.

ASSESSMENT

Pre-morbid Nottingham Extended ADL Score28 andOxford Handicap Scale score were registered retrospec-tively. The Mini Mental State Examination28 and theBarthel ADL Index were registered by members of thestaV in the stroke unit on the seventh day after stroke.

The assessments at three and six months after thestroke were performed by a specially trained nursewho was informed neither about the design nor thehypothesis of the study. The nurse was not involved inthe care of the patient and had no contact with patientsor carers between the interviews. Instrumental activitiesof daily living (IADL) registered by the NottinghamExtended ADL Scale served as primary outcomemeasure, with higher scores re¯ecting increased func-tion. The 20-question version of the General HealthQuestionnaire 30, 31 for both patients and relatives, servedas a secondary outcome measure, with higher scoresre¯ecting increased psychological dysfunction. In addi-tion, the Montgomery Aasberg Depression RatingScale32 was recorded as well as re-admission, place ofresidence and death. Information about ongoing healthservices was gathered in both groups from patients andrelatives. For each subject, community staV were askedwhether care had been provided by a multidisciplinaryteam co-ordinating their eVorts through regular meet-ings. Patient and carer satisfaction at three months afterstroke was registered on a four-point Likert scale ofagreement with a statement of satisfaction with thecontinued rehabilitation. Information on the experi-ences regarding the feasibility of the ESD strategy wasgathered among members of the stroke team and otherhealth professionals involved.

ANALYSIS

Our aim was to include at least 120 subjects in thestudy, which it was assumed would be su� cient to detectan odds ratio of 0.4 in either direction, i.e. if a propor-tion of one group has an extended ADL score of a givencategory or better, then the corresponding proportion ofthe other group would be 60% lower.33 However, theinclusion rate of patients was lower than expected,owing in part to reduction in the capacity of the stroke

unit, which meant that the patients were admitted togeneral medical wards. It was realized that an extensionof the inclusion period would not be feasible within areasonable time scale to give a signi®cant improvementin statistical power. Therefore it was decided to stoprecruitment when 82 subjects had been included.

Data were analysed on an intention-to-trea t basis.34

Comparison between the two groups was carried outby the Mann±Whitney test. For multivariate adjust-ments by logistic regression analysis, the outcome wasdichotomized at the median and the linearity of ordinalexplanatory variables as well as ®t of the regressionmodel was checked by standard methods.35 Computa-tions were carried out with the BMDP36 and the CIA37

computer programmes.

Results

Figure 1 shows the ¯ow of patients through the study.During the inclusion period, 436 stroke patients wereregistered, of whom 88 (20.2 %) were found eligible.Information about patients considered for eligibility isgiven in table 1.

Six eligible patients declined participation, whileonly one of those randomized to the ESD group didnot consent. A few patients in both groups withdrewfrom follow up (®gure 1), mainly as they did not wish

Table 1 Reasons for exclusion from the early supported dischargestudy

n (%)

Stroke patients admitted to the Acute Stroke Unit 436

Not resident in the study area 3 ( 0.7 )

Admitted from nursing home 2 ( 0.5 )

Admitted to hospital45 days post stroke 12 ( 2.8 )

Admitted too late to the Acute Stroke Unit

( from other wards ) 13 ( 3.0 )

Previously severely handicapped ( Oxford Handicap

scale 4 or 5 ) 19 ( 4.4 )

Comorbid condition likely to preclude rehabilitation 10 ( 2.3 )

Medically unstable 72 hours post stroke 22 ( 5.0 )

Cognitive impairment 44 ( 10.1 )

Barthel ADL Index 55 at 72 hours 89 ( 20.4 )

Barthel ADL Index 419 at 72 hours 127 ( 29.1 )

O ther reason for exclusion 7 ( 1.7 )

E ligible to participate in study 88 ( 20.2 )

Refused or unable to gain consent ( stage 1 ) 3

Other reason for not randomising 3

Randomized 82 ( 18.8 )

Characteristics of excluded subjects: 60% were females and the median

age was 77 years.

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to participate in the rather extensive assessment proce-dures. There was an increased proportion of femalesamong those lost to follow-up (p=0.03), while therewere no signi®cant diVerences regarding age or strokeseverity. Table 2 shows the baseline characteristics ofthe two study groups. There were no signi®cant diVer-ences in demography or stroke severity; however, thepremorbid Nottingham Extended ADL score, theBarthel ADL Index score was higher and the propor-tion of patients with a right hemisphere lesion largerin the ESD group, but none were statistically signi®-cant.

Length of stay in hospital (median) was 22 days in theESD group and 31 days in the control group (p=0.09).The diVerence in length of stay was not altered when

including re-admissions in the total length of stay. Therewere no signi®cant diVerences regarding re-admissionsat between the ESD and CSR groups (two versus fourat three months and three versus four at six). There wereno reported accidents or dangerous situations afterdischarge in any of the groups.

Table 3 shows the primary and secondary outcomemeasures at three and six months. The IADL scoreimproved signi®cantly between the two study points inboth the ESD and CRS groups (p=0.05/0.02), whiledepression score and subjective well-being showed nosigni®cant change. The IADL score was higher in theintervention group at both assessment points, but thediVerences between the groups did not reach statisticalsigni®cance.

n

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RANDOMIZATION

* One participant did not consent to intervention, whereas two did not meet the ESD criteria owing to dischargeto in-patient rehabilitation

Figure 1 Progress of patients through the randomized controlled trial.

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At three months, the GHQ score showed a signi®cantdiVerence in favour of the ESD group. This diVerencewas not seen at six months.

In spite of the randomization procedure, it appearedto be a clinically important but non-statistical diVerencebetween the two groups regarding stroke severity asmeasured by the Barthel ADL Index score as well ashemispheric localization. As clinical features do predictoutcome after stroke, these diVerences were adjustedfor by logistic regression analysis. The bene®cial eVectof the ESD on the GHQ score persisted, the odds ratio(95% con®dence interval) for an unfavourable outcomebeing 0.31 (0.09 ± 0.99) after adjustment for stroke sever-ity and 0.33 (0.10 ± 1.05) after additional adjustment forhemispheric localization.

There were no signi®cant diVerences in the occurrenceof depression among patients or the GHQ score amongthe relatives at any point of time. The proportion ofparticipants (18/24, 10/21, p=0.06) and carers (12/19,3/10, p=0.09) reporting to be satis®ed with the contin-ued care from the primary health care was higher inthe ESD group, but did not achieve statistical signi®-cance.

Table 4 shows the number of subjects who were deador in need of permanent institutional care at the twostudy points. Using the combined outcome of death orinstitutional care, the probability of a negative outcomeat six months was higher in the CRS group, the diVer-ence reaching borderline signi®cance (OR 3.8 95 CI0.8 ± 23.1).

Table 2 Baseline comparison between the study groups in the early supported discharge study

ESD (n=42) CRS (n=40) p-value

Age in years: median ( IQR )* 79.5 ( 69 ±84 ) 78.0 ( 74 ±82 ) 0.70

Gender: female 21 ( 50% ) 24 ( 60% ) 0.36

Living alone 24 ( 57% ) 25 ( 63% ) 0.62

Premorbid Oxford Handicap Scale score: median ( IQR )* 0 ( 0 ±1 ) 0 ( 0 ±1 ) 0.94

Premorbid Nottingham Extended ADL total score: median ( IQR )* 35 ( 28 ±44 ) 30 ( 14 ±46 ) 0.72

Barthel ADL Index sum score at day 7: median ( IQR )* 16.5 ( 12 ±19 ) 14 ( 11 ±18 ) 0.21

Right hemisphere stroke 23 ( 54% ) 14 ( 35% ) 0.07{Left hemisphere stroke 16 ( 38% ) 23 ( 57% )

Posterior stroke 3 ( 7% ) 3 ( 8% )

Mini-Mental State Examination sum score at day 7: median ( IQR )* 27.5 ( 24 ±29 ) 27 ( 22 ±30 ) 0.74

*IQR: interquartile range

{p-value for diVerence between right and left hemisphere, posterior strokes included.

Table 3 Outcome at three and six months (extended ADL, subjective well-being and depression) in the early supported discharge study

3 months post stroke 6 months post stroke

Median (IQR)* Median (IQR)*

ESD CRS 95% CI{ ESD CRS 95% CI{(n=34) (n=32) of diVerence p-value{{ (n=34) (n=31) of diVerence p-value{{

Nottingham extended ADL:

Mobility 10.5 ( 4 ±14 ) 8 ( 3 ±15 ) ( 72 to 4 ) 0.41 11 ( 6 ±14 ) 10 ( 4 ±15 ) ( 72 to 4 ) 0.55

Kitchen 12 ( 8 ±14 ) 12 ( 6 ±15 ) ( 72 to 1 ) 0.87 12 ( 8 ±15 ) 13 ( 10 ±15 ) ( 72 to 1 ) 0.52

Domestic 6 ( 3 ±8 ) 5 ( 3 ±10 ) ( 73 to 1 ) 0.58 5.5 ( 4 ±8 ) 6 ( 3 ±11 ) ( 73 to 1 ) 0.47

Leisure 8 ( 6 ±9 ) 6 ( 5 ±9 ) ( 71 to 2 ) 0.38 7.5 ( 6 ±10 ) 7 ( 6 ±9 ) ( 71 to 2 ) 0.55

Total 34.5 ( 28 ±44 ) 30 ( 14 ±46 ) ( 78 to 7 ) 0.78 40 ( 29 ±45 ) 37 ( 20 ±46 ) ( 78 to 7 ) 0.93

General health questionnaire} 19.5 ( 14 ±26 ) 26 ( 19 ±31 ) ( 79 to 71 ) 0.02 24 ( 16 ±27 ) 22 ( 17 ±26 ) ( 74 to 4 ) 0.74

Montgomery Asberg Depression

rating scale} 1.5 ( 0 ±4 ) 2.5 ( 0 ±6 ) ( 72 to 0 ) 0.10 2.0 ( 0 ±6 ) 2.0 ( 1 ±5 ) ( 72 to 1 ) 0.30

*IQR: inter quartile range

{CI: con®dence interval

{{Mann±Whitney test

}Owing to a few dropouts, n for this variable at three months is 33/32 in the ESD and CRS groups, respectively. At six months it is 33/31 respectively.

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Table 5 shows the number of participants receivingdomiciliary services at three and six months in the twogroups. There was no signi®cant diVerence betweenthe groups in any of the services. Out of 42 patients inthe ESD group, seven did not for several reasons receiveany services in the community. The rest had receivedmultidisciplinary support of diVerent types and inten-sity, and 37% of these local teams based their activitieson regular meetings. In the CRS group, team-formationwith regular meetings was accomplished in only onesingle case.

Discussion

Our study has compared organized in-patient rehabi-litation with early supported discharge. No diVerencehas been found in extended activities of daily livingbetween these groups. An important characteristic ofthis study is that all patients received stroke unit care,which means that the CRS group received gold standardpatient care from their very ®rst day in hospital. Thishas not been the case for all previous ESDstudies,13, 15±17 which makes it di� cult to interpret theresults from these trials.

Patients’ perception of well-being should be consid-ered an important outcome in rehabilitation. In ourstudy, this was measured by the GHQ-20 score. TheESD group reported better subjective well-being thanthe CRS group at three months, and this diVerencereached statistical signi®cance despite the limited statis-tical power of the study. It also persisted after adjust-ment for diVerences in stroke severity betweenrandomization groups. This result may be explainedby the anticipated emotional and social advantages ofstaying at home rather than in hospital. However, therewas no access to baseline data to con®rm what similari-ties were in the two groups in this respect in the begin-ning, and our ®ndings were not supported by otherESD studies.13±17 At six months, the subjective well-being had decreased in the ESD group, and there wasno signi®cant diVerence between the groups. It is possi-

ble that the emotional bene®t of an early return to homeis temporary.

A trend of improved outcome in terms of death orinstitutional care was seen in the ESD group. A metaanalysis including the ESD studies which used a co-ordinated team in community rehabilitation,13±15

showed a similar trend in favour of the ESD group.Our data give no explanation of this result, but it ispossible that it re¯ects a negative consequence of elderlypeople staying in hospital too long.

There was no diVerence in reported subjective well-being among relatives in the two groups. This is contra-dictory to another study, where mental stress was foundto be signi®cantly lower in the CRS group after sixmonths.16 However, the other ESD studies so far givelittle information about the impact of such services onthe mood and well-being of carers.20

The reduction in median length of hospital stay in theESD group (9 days, 29%) was quite similar to most ofthe other ESD studies.16±18, 20 The diVerence probablyre¯ects the two alternative strategies of rehabilitation,and should give reasonable time to establish the alterna-tive conditions and measures believed to be of impor-tance in rehabilitation at home.

The number of stroke patients eligible for this kind ofservice in the study was 20%, which was less thanachieved in most other ESD studies.13±16, 18 It is impor-

Table 4 Outcome after three and six months (survival and place of residence) in the early supported discharge study

3 months post stroke 6 months post stroke

ESD CRS OR (95% CI*) ESD CRS OR (95% CI*)

Alive/dead 40/2 37/3 1.6 ( 0.2 ±14.9 ) 40/2 36/4 2.2 ( 0.3 ±25.7 )

Home/institutional care 38/2 32/5 3.0 ( 0.5 ±24.0 ) 39/1 31/5 6.3 ( 0.6 ±305 )

Home/death or institutional care 38/4 32/8 2.4 ( 0.6 ±10.5 ) 39/3 31/9 3.8 ( 0.8 ±23.1 )

*CI: con®dence interval calculated by Fischer exact methodology.

Table 5 Provision of health services in the early supported dischargestudy

3 months 6 months

ESD CRS ESD CRS

(n=34) (n=32) (n=34) (n=31)

Services n (%) n (%) n (%) n (%)

District nursing 13 ( 36.1 ) 7 ( 21.9 ) 9 ( 26.5 ) 6 ( 19.4 )

Home care 16 ( 44.4 ) 13 ( 40.6 ) 17 ( 50.0 ) 14 ( 45.2 )

Occupational therapy 7 ( 19.4 ) 5 ( 15.6 ) 2 ( 5.9 ) 4 ( 12.9 )

Physiotherapy 22 ( 61.1 ) 14 ( 43.8 ) 17 ( 50.0 ) 11 ( 35.5 )

*There was no signi®cant diVerence between the study groups at any

point of time, regarding any type of service.

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tant in any rehabilitation service or clinical trial that theintervention is appropriately targeted. On re¯ection, it isstill felt that the inclusion criteria were valid. Because ofthe wide range of the clinical presentations of stoke, it isunlikely that complex rehabilitation interventions willbe suitable for most patients.

Compared with the CRS group, the continued reha-bilitation in the ESD group was de®nitely better orga-nized. This ®nding was supported by the trend ofgreater satisfaction with the provided health servicesamong patients and relatives in the ESD group, whichis similar to the ®ndings in other studies.14, 15 It is there-fore possible that this study not only tests the eVective-ness of an early discharge strategy, but also that ofbetter continued rehabilitation after discharge. On theother hand, there is reason to believe that the contin-ued rehabilitation was less intensive in our study thanin some others.13±17

In conclusion, the study has indicated that an earlysupported discharge strategy for selected patients withacute stroke is feasible in Norway. No adverse reactionsto the strategy were recorded, and subjective well-beingof patients was enhanced by this scheme. It is alsopossible that the criteria for such treatment could bebroadened. If the time window for selection is extended,it would probably increase the proportion of patientssuitable for this intervention.

It should be pointed out that while the data must betreated with caution on account of the limited statisticalpower, it will make a contribution to the ongoing metaanalyses with other studies.

However, there is an obvious need for furtherresearch. Large multi-centre randomized controlledtrials of complex interventions such as ESD follow-ing stroke are di� cult to undertake. Standardizationof the service provided to the intervention andcontrol group in such trials is neither feasible norappropriate as stroke services evolve to meet thelocal needs. Increased knowledge of the eVectivenessof ESD must therefore to a large extent, be basedon small studies, as they demonstrate the feasibilityof the strategy in a number of diVerent settings.In addition, the results of subsequent meta analysescan be generalized and the implications for an earlysupported discharge policy after stroke better under-stood.

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