title: Cluster Randomized Controlled Trial: Clinical and Cost-Effectiveness of a System of Longer-Term Stroke Care.
abstract: OBJECTIVE
  We developed a new postdischarge system of care comprising a structured assessment covering longer-term problems experienced by patients with stroke and their carers, linked to evidence-based treatment algorithms and reference guides (the longer-term stroke care system of care) to address the poor longer-term recovery experienced by many patients with stroke.
  
  
  METHODS
  A pragmatic, multicentre, cluster randomized controlled trial of this system of care. Eligible patients referred to community-based Stroke Care Coordinators were randomized to receive the new system of care or usual practice. The primary outcome was improved patient psychological well-being (General Health Questionnaire-12) at 6 months; secondary outcomes included functional outcomes for patients, carer outcomes, and cost-effectiveness. Follow-up was through self-completed postal questionnaires at 6 and 12 months.
  
  
  RESULTS
  Thirty-two stroke services were randomized (29 participated); 800 patients (399 control; 401 intervention) and 208 carers (100 control; 108 intervention) were recruited. In intention to treat analysis, the adjusted difference in patient General Health Questionnaire-12 mean scores at 6 months was -0.6 points (95% confidence interval, -1.8 to 0.7; P=0.394) indicating no evidence of statistically significant difference between the groups. Costs of Stroke Care Coordinator inputs, total health and social care costs, and quality-adjusted life year gains at 6 months, 12 months, and over the year were similar between the groups.
  
  
  CONCLUSIONS
  This robust trial demonstrated no benefit in clinical or cost-effectiveness outcomes associated with the new system of care compared with usual Stroke Care Coordinator practice.
  
  
  BACKGROUND
  URL: http://www.controlled-trials.com. Unique identifier: ISRCTN 67932305.
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.). a.forster@leeds.ac.uk.
authors.forename: Anne
authors.initials: A
authors.lastname: Forster
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.).
authors.forename: John
authors.initials: J
authors.lastname: Young
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.).
authors.forename: Katie
authors.initials: K
authors.lastname: Chapman
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.).
authors.forename: Jane
authors.initials: J
authors.lastname: Nixon
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.).
authors.forename: Anita
authors.initials: A
authors.lastname: Patel
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.).
authors.forename: Ivana
authors.initials: I
authors.lastname: Holloway
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.).
authors.forename: Kirste
authors.initials: K
authors.lastname: Mellish
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.).
authors.forename: Shamaila
authors.initials: S
authors.lastname: Anwar
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.).
authors.forename: Rachel
authors.initials: R
authors.lastname: Breen
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.).
authors.forename: Martin
authors.initials: M
authors.lastname: Knapp
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.).
authors.forename: Jenni
authors.initials: J
authors.lastname: Murray
authors.affiliation: From the Academic Unit of Elderly Care and Rehabilitation, Bradford Teaching Hospitals NHS Foundation Trust (A. Forster, J.Y., K.C., K.M., R.B.), Leeds Institute of Clinical Trials Research, Clinical Trials Research Unit (J.N., I.H., S.A., A. Farrin), and Leeds Institute of Health Sciences (J.M.), University of Leeds, Leeds, United Kingdom; Institute of Psychiatry, King's College London, London, United Kingdom (A.P.); and Personal Social Services Research Unit, London School of Economics and Political Science, London, United Kingdom (M.K.).
authors.forename: Amanda
authors.initials: A
authors.lastname: Farrin
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D016000:Cluster Analysis; D003362:Cost-Benefit Analysis / Q000379:methods* / Q000639:trends; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008134:Long-Term Care / Q000191:economics* / Q000379:methods / Q000639:trends; D008297:Male; D008875:Middle Aged; D020521:Stroke / Q000191:economics* / Q000628:therapy*
keywords: cluster randomized controlled trial; community health services; cost-benefit analysis; quality-adjusted life years; rehabilitation; stroke