title: Prevention of delirium (POD) for older people in hospital: study protocol for a randomised controlled feasibility trial.
abstract: BACKGROUND
  Delirium is the most frequent complication among older people following hospitalisation. Delirium may be prevented in about one-third of patients using a multicomponent intervention. However, in the United Kingdom, the National Health Service has no routine delirium prevention care systems. We have developed the Prevention of Delirium Programme, a multicomponent delirium prevention intervention and implementation process. We have successfully carried out a pilot study to test the feasibility and acceptability of implementation of the programme. We are now undertaking preliminary testing of the programme.
  
  
  METHODS
  The Prevention of Delirium Study is a multicentre, cluster randomised feasibility study designed to explore the potential effectiveness and cost-effectiveness of the Prevention of Delirium Programme. Sixteen elderly care medicine and orthopaedic/trauma wards in eight National Health Service acute hospitals will be randomised to receive the Prevention of Delirium Programme or usual care. Patients will be eligible for the trial if they have been admitted to a participating ward and are aged 65 years or over. The primary objectives of the study are to provide a preliminary estimate of the effectiveness of the Prevention of Delirium Programme as measured by the incidence of new onset delirium, assess the variability of the incidence of new-onset delirium, estimate the intracluster correlation coefficient and likely cluster size, assess barriers to the delivery of the Prevention of Delirium Programme system of care, assess compliance with the Prevention of Delirium Programme system of care, estimate recruitment and follow-up rates, assess the degree of contamination due to between-ward staff movements, and investigate differences in financial costs and benefits between the Prevention of Delirium Programme system of care and standard practice. Secondary objectives are to investigate differences in the number, severity and length of delirium episodes (including persistent delirium); length of stay in hospital; in-hospital mortality; destination at discharge; health-related quality of life and health resource use; physical and social independence; anxiety and depression; and patient experience.
  
  
  CONCLUSIONS
  This feasibility study will be used to gather data to inform the design of a future definitive randomised controlled trial.
  
  
  BACKGROUND
  ISRCTN01187372 . Registered 13 March 2014.
authors.affiliation: Academic Unit of Elderly Care and Rehabilitation, University of Leeds, Bradford Institute for Health Research, Temple Bank House, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK. john.young@bthft.nhs.uk.
authors.forename: John
authors.initials: J
authors.lastname: Young
authors.affiliation: School of Nursing Sciences, Faculty of Medicine and Health Sciences, University of East Anglia, Edith Cavell Building, Norwich Research Park, Norwich, NR4 7TJ, UK. f.cheater@uea.ac.uk.
authors.forename: Francine
authors.initials: F
authors.lastname: Cheater
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. m.collinson@leeds.ac.uk.
authors.forename: Michelle
authors.initials: M
authors.lastname: Collinson
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. m.fletcher@leeds.ac.uk.
authors.forename: Marie
authors.initials: M
authors.lastname: Fletcher
authors.affiliation: Academic Unit of Elderly Care and Rehabilitation, University of Leeds, Bradford Institute for Health Research, Temple Bank House, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK. a.forster@leeds.ac.uk.
authors.forename: Anne
authors.initials: A
authors.lastname: Forster
authors.affiliation: Leeds Institute of Health Sciences, Charles Thackrah Building, 101 Clarendon Road, Leeds, UK. m.godfrey@leeds.ac.uk.
authors.forename: Mary
authors.initials: M
authors.lastname: Godfrey
authors.affiliation: Academic Unit of Elderly Care and Rehabilitation, University of Leeds, Bradford Institute for Health Research, Temple Bank House, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK. john.green@bthft.ac.uk.
authors.forename: John
authors.initials: J
authors.lastname: Green
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. s.t.anwar@leeds.ac.uk.
authors.forename: Shamaila
authors.initials: S
authors.lastname: Anwar
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. s.hartley@leeds.ac.uk.
authors.forename: Suzanne
authors.initials: S
authors.lastname: Hartley
authors.affiliation: Academic Unit of Health Economics, Leeds Institute of Health Science, University of Leeds, Leeds, LS2 9JT, UK. c.t.hulme@leeds.ac.uk.
authors.forename: Claire
authors.initials: C
authors.lastname: Hulme
authors.affiliation: Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, 02215, USA. agingbraincenter@hsl.harvard.edu.|Aging Brain Center, Institute for Aging Research, Hebrew SeniorLife, 1200 Centre Street, Boston, MA, 02131, USA. agingbraincenter@hsl.harvard.edu.
authors.forename: Sharon K
authors.initials: SK
authors.lastname: Inouye
authors.affiliation: Academic Unit of Health Economics, Leeds Institute of Health Science, University of Leeds, Leeds, LS2 9JT, UK. d.meads@leeds.ac.uk.
authors.forename: David
authors.initials: D
authors.lastname: Meads
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. g.santorelli@leeds.ac.uk.
authors.forename: Gillian
authors.initials: G
authors.lastname: Santorelli
authors.affiliation: Leeds Institute of Health Sciences, Charles Thackrah Building, 101 Clarendon Road, Leeds, UK. n.siddiqi@leeds.ac.uk.|Bradford District NHS Care Trust New Mill, Victoria Road, Saltaire, BD18 3LD, UK. n.siddiqi@leeds.ac.uk.
authors.forename: Najma
authors.initials: N
authors.lastname: Siddiqi
authors.affiliation: Academic Unit of Elderly Care and Rehabilitation, University of Leeds, Bradford Institute for Health Research, Temple Bank House, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK. jane.smith@bthft.nhs.uk.
authors.forename: Jane
authors.initials: J
authors.lastname: Smith
authors.affiliation: Academic Unit of Elderly Care and Rehabilitation, University of Leeds, Bradford Institute for Health Research, Temple Bank House, Bradford Royal Infirmary, Duckworth Lane, Bradford, BD9 6RJ, UK. elizabeth.teale@bthft.nhs.uk.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Teale
authors.affiliation: Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK. a.j.farrin@leeds.ac.uk.
authors.forename: Amanda J
authors.initials: AJ
authors.lastname: Farrin
mesh_terms: D000367:Age Factors; D000368:Aged; D002985:Clinical Protocols; D016000:Cluster Analysis; D003362:Cost-Benefit Analysis; D003693:Delirium / Q000175:diagnosis / Q000191:economics / Q000209:etiology / Q000401:mortality / Q000517:prevention & control* / Q000523:psychology; D005240:Feasibility Studies; D005260:Female; D015577:Geriatric Assessment; D017721:Hospital Costs; D017052:Hospital Mortality; D006801:Humans; D007297:Inpatients; D007902:Length of Stay; D008297:Male; D012107:Research Design; D012307:Risk Factors; D018401:Sample Size; D013222:State Medicine; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom