PapersDomiciliar y occupational therapy for patients with strokedischarged from hospital: randomised controlled trialLouise Gilbertson, Peter Langhorne, Andrew Walker, Ann Allen, Gordon D MurrayAbstractObjective To establish if a brief programme ofdomiciliary occupational therapy could improve therecovery of patients with stroke discharged fromhospital.Design Single blind randomised controlled trial.Setting Two hospital sites within a UK teachinghospital.Subjects 138 patients with stroke with a definite planfor discharge home from hospital.Intervention Six week domiciliary occupationaltherapy or routine follow up.Main outcome measures Nottingham extendedactivities of daily living score and “global outcome”(deterioration according to the Barthel activities ofdaily living index, or death).Results By eight weeks the mean Nottinghamextended activities of daily living score in theintervention group was 4.8 points (95% confidenceinterval − 0.5 to 10.0, P = 0.08) greater than that ofthe control group. Overall, 16 (24%) interventionpatients had a poor global outcome compared with30 (42%) control patients (odds ratio 0.43, 0.21 to0.89, P = 0.02). These patterns persisted at six monthsbut were not statistically significant. Patients in theintervention group were more likely to reportsatisfaction with a range of aspects of services.Conclusion The functional outcome and satisfactionof patients with stroke can be improved by a briefoccupational therapy programme carried out in thepatient’s home immediately after discharge. Majorbenefits may not, however, be sustained.IntroductionDischarge home from hospital can be a critical stage inthe rehabilitation of patients with stroke. The earlyrecovery and new skills achieved in hospital may bedifficult to transfer to the home environment.1 2 Poorcoordination of planning of discharge, lack of access toservices, psychosocial problems, and reduced quality oflife are also common experiences at this time.1 3 Homebased rehabilitation has been proposed to addressthese needs, and recent trials indicate that interven-tions for occupational therapy at home are feasible andpossibly effective.4 5 We therefore aimed to establish abrief outreach service for occupational therapy and to evaluate whether it could improve the recovery ofpatients with stroke discharged home from hospital.Participants and methodsStudy populationPatients with a clinical diagnosis of stroke (excludingsubarachnoid haemorrhage) who were admitted to aGlasgow royal infirmary NHS trust were eligible if theyhad been referred to the occupational therapy depart-ment and if a discharge date had been set. We excludedonly patients for whom the service might beinappropriate (full recovery, discharge to institutionalcare, terminal illness), those living outside the hospitalarea, and those unable to take part in the trial (severecognitive or communication problems preventingconsent, completion of outcome measures, or theagreement of simple goals for recovery).AssignmentEligible patients were contacted by the study therapist(LG) who obtained baseline data and informedconsent. Patients were told the study would comparetwo types of follow up; routine services (control group)or routine services plus domiciliary occupationaltherapy (intervention). The therapist telephoned anindependent central office where baseline data werelogged before allocation. Patients were randomlyallocated to either intervention by a computergenerated schedule stratified by sex and attendance ata day hospital contained in sequentially numberedopaque sealed envelopes. The study was approved bythe local ethics committee.InterventionsRoutine ser vicesRoutine services included inpatient multidisciplinaryrehabilitation, a predischarge home visit for selectedpatients, the provision of support services andequipment, regular multidisciplinary review at a strokeclinic, and selected patients referred to a medical dayhospital.Inter vention ser viceThe intervention service was designed to be client cen-tred and was developed through focus group sessionswith patients, carers, and local occupational therapystaff.3 From these sessions a six week domiciliary Department ofOccupationalTherapy, GlasgowRoyal Infirmary,Glasgow G4 0SFLouise Gilbertsonresearch occupationaltherapistAnn AllenhelperAcademic Sectionof GeriatricMedicine, GlasgowRoyal InfirmaryPeter Langhornesenior lecturerGreater GlasgowHealth Board,Dalian House,Glasgow G3 8YUAndrew Walkerhealth economistDepartment ofCommunity HealthSciences, MedicalStatistics Unit,University ofEdinburgh MedicalSchool, EdinburghEH8 9AGGordon D Murrayprofessor of medicalstatisticsCorrespondence to:P LanghorneP.Langhorne@clinmed.gla.ac.ukBMJ 2000;320:603–6603BMJ VOLUME 320 4 MARCH 2000 www.bmj.com
programme was developed (comprising around 10visits lasting 30-45 minutes) tailored to recovery goalsidentified by the patient such as regaining self care ordomestic or leisure activities. The therapist workedwith the patient to achieve these goals and also liaisedwith other agencies for advice, services, and equip-ment.OutcomesBaseline data were collected before randomisation,with follow up by interview after the interventionperiod (eight weeks) and postal outcome questionnaireat six months. The primary outcomes were theNottingham extended activities of daily living scale andthe “global outcome” of deterioration according to theBarthel activities of daily living index, or death.6Secondary outcomes included the Barthel index, satis-faction with outpatient services,7 resource use (stafftime, hospital readmission, provision of equipmentand services), and measures of subjective health.3We aimed to recruit a minimum of 128 patients toachieve an 80% power at 5% significance to detect anine point difference in the Nottingham scores (66point version) or a halving of the risk of poor globaloutcome. The outcome assessor (AA), who was blindedto treatment allocation, was based in a separate depart-ment from the research therapist.Statistical analysesAll outcome data were coded, checked, and analysedon an intention to treat basis by an independent statis-tician. As there was a modest imbalance at baseline inseverity of stroke a post hoc decision was made toexplore the effects of adjusting the analysis for the baseline Barthel index. The total Nottingham scorewas well approximated by a normal distribution, and sothe primary analysis was by two sample t test,supported by an analysis of covariance, adjusting forbaseline Barthel index and the two stratification factorsof sex and referral to a day hospital. The globaloutcome was analysed with logistic regression, withand without adjustment for the two stratifying factors.The distribution of the Barthel index was skewedtowards the upper end of the score, but normal basedmethods were still used as this allowed adjustment forthe baseline assessment.ResultsAround 650 patients were admitted with suspectedstroke or transcient ischaemic attack during an 18month period, of whom 523 were admitted for at leastthree days with functional problems; we excluded 385patients, and we randomised 67 patients to theintervention group and 71 to the control group, repre-senting 58% (138/237) of patients with residual strokedisability who returned to a local private address(figure).Baseline characteristicsThe intervention group tended to have more severestrokes at baseline than the control group: hemiano-pia, a lower Barthel index, and longer hospital stay(table 1). Three patients in the intervention group wereincorrectly diagnosed with stroke (all had malig-nancies), and one patient in the intervention groupand one in the control group were given a dischargedate but never discharged. These patients remained intheir allocated groups throughout this analysis.Functional outcomesThe unadjusted analysis at eight weeks (table 2)showed that the intervention group had a mean523 patients withfunctional problems138 randomised 358 not randomised:167 died or discharged to institutional care62 full recovery or occupational therapy not appropriate57 unable to complete assessment or in other study48 final diagnosis not stroke32 outside catchment area13 refused6 missed71 allocatedroutine services 67 allocatedinterventionservice69 assessed at 8 weeks 64 assessed at 8 weeks63 assessed at 6 months 60 assessed at 6 monthsAround 650 patients admitted with stroke or transient ishaemic attackRandomisation1 dead1 unable to completeall assessments4 dead2 unable to completeall assessments 2 dead1 unable to completeall assessments4 deadTrial profile Table 1 Patient characteristics at randomisation. Values arenumbers (percentages) unless stated otherwiseCharacteristics Interventiongroup (n=67) Controlgroup(n=71)PatientAge (years; interquartile range) 71 (28-89) 71 (31-89)Male 29 (43) 31 (44)Living alone 31 (46) 24 (34)Rankin score before stroke:0-2 62 (93) 66 (93)3-4 5 (7) 5 (7)StrokeLaterality: right hemisphere 33 (49) 38 (53)Hemiparesis 60 (90) 60 (84)Hemisensory loss 19 (28) 14 (20)Visual or spatial inattention 13 (19) 16 (22)Hemianopia 16 (24) 7 (10)Dysphasia 22 (33) 16 (22)Brain stem or cerebellar signs 9 (13) 4 (6)Cognitive impairment 13 (20) 19 (27)Anxiety 14 (21) 17 (24)Depression 5 (7) 5 (7)OtherMedian duration (days) since symptom onset(interquartile range) 31 (17-57) 23 (13-66)Median Barthel index score (interquartile range) 17 (15-18) 18 (16-19)Referral to medical day hospital 16 (24) 21 (30)Papers604 BMJ VOLUME 320 4 MARCH 2000 www.bmj.com
Nottingham score 4.8 points higher than that of thecontrol group (95% confidence interval − 0.5 to 10.0,P = 0.08). In the corresponding adjusted analysis themean difference was 5.7 points (1.2 to 10.3, P = 0.02).Significantly fewer patients in the intervention groupexperienced a poor global outcome (odds ratio 0.43,0.21 to 0.89, P = 0.02). A similar pattern was seen withthe Barthel index scores (table 2).At six months the results for primary outcomeswere no longer statistically significant (table 2). Morepatients in the intervention than control group were,however, likely to have improved and the change inBarthel index scores in these patients was significantlybetter than in the controls.Patient satisfactionOverall, 44 patients in the intervention group and 43in the control group returned a questionnaire aboutsatisfaction with service delivery at home.7 Patients inthe intervention group were more likely to report sat-isfaction across all 12 questions (summary odds ratiofor agreement with statements 1.8, 1.4 to 2.4). Inparticular they were significantly more likely to agreethat “things were well prepared for returning home”and that they “knew who to contact with problemsrelating to my stroke.”Resource useThe groups were evenly matched at the six months’follow up for place of residence, readmissions to hospi-tal, additional services and equipment provided, andcosts incurred by patients and carers.3 Staff costs(including travel) accounted for 85%-90% of allexpenditure. We estimate that one whole time therapistcould manage 80-90 patients per year at a cost of about£300-£320 per patient and prevent 10 poor outcomes(deterioration in function) after discharge home—thatis, costing about £2500 per poor outcome avoided.UnblindingThe outcome assessor was asked to guess theallocation of the last 46 patients followed up, and sheguessed correctly in 32 cases (69%, 56% to 83%). Thecommonest reason was knowing whether the patienthad attempted an activities of daily living activity (inparticular bathing), which should have been addressedin the occupational therapy programme.DiscussionMethodological issuesOur trial shows that patients with stroke who havereceived multidisciplinary rehabilitation in hospitalincorporating discharge planning and multidiscipli-nary follow up can still benefit from a short outreachprogramme for occupational therapy. The initial statis-tically significant benefits were diminished at the sixmonth follow up, which could reflect the method offollow up (postal versus interview) or a transient effectof the rehabilitation input. It is possible that the earlybenefits were maintained at six months as the wideconfidence intervals do not exclude this possibility. Wehave tried to ensure a rigorous but pragmaticevaluation of a new service using a rigorous randomi-sation procedure and independent intention to treat analysis. We do, however, acknowledge the difficulty inblinding rehabilitation trials. Unblinding of theoutcome assessor may not have biased recording ofoutcomes since the main reason she guessed treatmentallocation was differences in components of theoutcome measures. The final (six month) outcomeswere reported by postal questionnaire and so were notprone to observer unblinding. Patients’ responses mayhave been influenced by their knowledge of their allo-cated group,7 but it is difficult to exclude this possibilityin a pragmatic trial with informed consent.Comparison with other studiesThe main weakness of our study is its comparativelysmall size, which meant it was prone to baseline differ-ences between patient groups and had limited powerto detect a modest effect on functional outcomes. Ourpower calculations were based on previous studies,which in comparison with our trial provided acomparatively prolonged therapy input to the inter-vention group and little input to controls.2 4 5 We weretherefore probably trying to detect smaller differencesbetween intervention and control patients than wasoriginally anticipated. Interestingly, a recent trial show-ing a positive impact of domiciliary occupationaltherapy also had a control group that received minimalinput.8 The apparently transient benefit of ourTable 2 Main functional outcome data. Values are medians (interquartile ranges) unlessstated otherwiseOutcome Descriptive statistics Unadjusted analysisIntervention(n=67) Control(n=71) Difference(95% CI) Pvalue8 weeksNo of deaths 2 1 — —No unable to complete all assessments 1 1 — —Nottingham extended activities of daily living score:Mobility 7 (4-12) 6 (2-10) 1 (−0.3 to 3.1) 0.11Domestic 15 (9-23) 11 (4-20) 4 (0.0 to 5.7) 0.05Leisure 7 (3-9) 6 (3-9) 1 (−0.8 to 1.8) 0.44Total* 27 (19-43) 23 (11-35) 4 (−0.5 to 10.0) 0.08Barthel activities of daily living index 18 (16-20) 17 (14-19) 1 (0.0 to 2.3) 0.06Change in Barthel index score sincerandomisation 1 (0-2) 0 (−3-1) 1 (0.7 to 2.7) 0.001Global outcome:No (%) with improved activities ofdaily living 38 (57) 25 (35) — 0.03No (%) with no change 13 (19) 16 (24) — —No (%) with worse activities of dailyliving or who had died 16 (24) 30 (42) — —Odds of a poor global outcome* — — 0.43 (0.21 to 0.89) 0.026 monthsNo of deaths 6 5 — —No unable to complete all assessments 1 3 — —Nottingham extended activities of daily living score:Mobility 8 (4-12) 6 (3-11) 2 (−1.0 to 2.5) 0.38Domestic 14 (6-21) 12 (5-19) 2 (−1.7 to 4.5) 0.36Leisure 6 (3-10) 6 (3-9) 0 (−1.6 to 1.3) 0.82Total* 28 (15-38) 21 (14-38) 7 (−3.6 to 7.8) 0.48Barthel activities of daily living index 17 (15-19) 17 (13-18) 0 (−0.6 to 2.4) 0.25Change in Barthel index since randomisation 0 (−2-2) −1 (−3-0) −1 (0.1 to 2.9) 0.04Global outcome:No (%) with improved activities ofdaily living 27 (42) 15 (22) — 0.04No (%) with no change 6 (9) 11 (16) — —No (%) with worse activities ofdaily living or who had died 32 (49) 42 (62) — —Odds of a poor global outcome* — — 0.60 (0.30 to 1.20) 0.15*Primary outcomes. 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intervention has been observed previously and used tojustify a more prolonged therapy input.4 5 Reducingthe longer term impact of stroke remains a majorchallenge.9ImplicationsOur results lend support to the principle of extendingroutine stroke rehabilitation from the inpatient periodto postdischarge period. Our resource analysis showsthat the service costs are significant but that one thera-pist could manage 80-100 patients per year andprevent about 10 deteriorating in function afterdischarge home. We did not attempt to reduce hospitalstay, but two recent British trials of early hospitaldischarge with a domiciliary multidisciplinary rehabili-tation have shown a shortening of the period ofinpatient care with no apparent adverse effect on patient outcomes.10 11 If confirmed, this potentiallyoffers a way of improving postdischarge rehabilitationwithout incurring major additional service costs.We thank the patients and carers who contributed to the study.Contributors: LG planned and conducted the trial anddrafted the final report. PL planned and supervised the trial; hewill act as guarantor for the paper. AW provided healtheconomic input and analysis. AA contributed to the design andconduct of the trial. GDM provided independent data analysisand statistical advice. All authors contributed to the redraftingand approval of the final report.Funding: Chest Heart and Stroke Scotland provided thefunding for this study. Additional support came from GlasgowRoyal Infirmary NHS Trust and the chief scientists office,Scottish Office, which funded a research training fellowship forLG.Competing interests: None declared.1 Forster A, Young J. Stroke rehabilitation: can we do better? BMJ1992;305:1446-7.2 Corr S, Bayer A. Occupational therapy for stroke patients after hospitaldischarge. Clin Rehab 1995;9:291-6.3 Gilbertson L. A randomised controlled trial of home based occupational therapyfor stroke patients. MSc thesis. University of Glasgow, 1998.4 Drummond AER, Walker MF. A randomised controlled trial of leisurerehabilitation. Clin Rehab 1995;9:283-90.5 Logan PA, Gladman JRF, Lincoln NB. A randomised controlled trial ofenhanced social service occupational therapy for stroke patients. ClinRehab 1997;11:107-13.6 Wade DT. Measurement in neurological rehabilitation. Oxford: Oxford Uni-versity Press, 1992.7 Dennis MS, O’Rourke S, Slattery J, Staniforth T, Warlow C. Evaluation ofa stroke family care worker: results of a randomised controlled trial. BMJ1997;314:1071-7.8 Walker MF, Gladman JRF, Lincoln N, Siemonsma P, Whiteley T. Occupa-tional therapy for stroke patients not admitted to hospital: a randomisedcontrolled trial. Lancet 1999;354:278-80.9 Gladman J, Barer D, Langhorne P. Specialist rehabilitation after stroke.Effective in the short term, but more work needed in the long term. BMJ1996;312:1623-4.10 Rudd AG, Wolfe CDA, Filling K, Beech R. Randomised controlled trial toevaluate early discharge scheme for patients with stroke. BMJ1997;315:1039-44.11 Rodgers H, Soutter J, Kaiser W, Pearson P, Dobson R, Skilbeck C, et al.Early supported hospital discharge following acute stroke: pilot studyresults. Clin Rehab 1997;11:280-7.(Accepted 13 December 1999)Six year sur vey of screening for Down’s syndrome bymaternal age and mid-trimester ultrasound scansDavid T Howe, Robert Gornall, Diana Wellesley, Tracy Boyle, John BarberAbstractObjective To assess the effectiveness of antenatalscreening for Down’s syndrome by maternal age androutine mid-pregnancy ultrasound scanning.Design Retrospective six year survey.Setting Maternity units of a district general hospital.Subjects Pregnant women booked for delivery inhospital between 1 January 1993 and 31 December1998.Main outcome measures All cases of Down’ssyndrome occurring in district identified fromregional congenital anomaly register and cytogeneticlaboratory records. Women’s case notes wereexamined to identify indication for karyotyping,gestation at diagnosis, and outcome of pregnancy.Results 31 259 deliveries occurred during studyperiod, and 57 cases of Down’s syndrome were identified, four in failed pregnancies and 53 inongoing pregnancies or in neonates. The analysis wasconfined to ongoing pregnancies or liveborn children.Invasive antenatal tests were performed in 6.6%(2053/31 259), and 68% (95% confidence interval56% to 80%) of cases of Down’s syndrome weredetected antenatally, giving a positive predictive valueof 1.8%. There were 17 undetected cases, and in sevenof these the women had declined an offer of invasivetesting. In women aged less than 35 years thedetection rate was 53% (30% to 76%). Most of thecases detected in younger women followedidentification of ultrasound anomalies.Conclusions The overall detection rate wasconsiderably higher than assumed in demonstrationprojects for serum screening. As a result, the benefitsof serum screening are much less than supposed.Before any new methods to identify Down’s syndromeWhat is already known on this topicPatients with stroke returning home from hospitaloften encounter unanticipated disability anddifficulties in adapting to the home environmentNo intervention has been shown to alleviate theseproblemsWhat this study addsA brief programme of domiciliary occupationaltherapy can enhance recovery and reduce the riskof deterioration in patients with stroke returninghomeRehabilitation should be extended beyonddischarge from hospitalPapersEditorial byRaeburnWessex Maternaland Fetal MedicineUnit, Princess AnneHospital,SouthamptonSO16 5YADavid T Howeconsultant infetomaternal medicineRobert Gornallspecialist registrar inobstetrics andgynaecologycontinued overBMJ 2000;320:606–10606 BMJ VOLUME 320 4 MARCH 2000 www.bmj.com