title: The PiTSTOP study: a feasibility cluster randomized trial of delirium prevention in care homes for older people.
abstract: delirium is a distressing but potentially preventable condition common in older people in long-term care. It is associated with increased morbidity, mortality, functional decline, hospitalization and significant healthcare costs. Multicomponent interventions, addressing delirium risk factors, have been shown to reduce delirium by one-third in hospitals. It is not known whether this approach is also effective in long-term care. In previous work, we designed a bespoke delirium prevention intervention, called 'Stop Delirium!' In preparation for a definitive trial of Stop Delirium, we sought to address key aspects of trial design for the particular circumstances of care homes.
  
  
  
  a cluster randomized feasibility study with an embedded process evaluation.
  
  
  
  residents of 14 care homes for older people in one metropolitan district in the UK.
  
  
  
  Stop Delirium!: a 16-month-enhanced educational package to support care home staff to address key delirium risk factors. Control homes received usual care.
  
  
  
  we collected data to determine the following: recruitment and attrition; delirium rates and variability between homes; feasibility of measuring delirium, resource use, quality of life, hospital admissions and falls; and intervention implementation and adherence.
  
  
  
  two-thirds (215) of eligible care home residents were recruited. One-month delirium prevalence was 4.0% in intervention and 7.1% in control homes. Proposed outcome measurements were feasible, although our approach appeared to underestimate delirium. Health economic evaluation was feasible using routinely collected data.
  
  
  
  a definitive trial of delirium prevention in long-term care is needed but will require some further design modifications and pilot work.
authors.affiliation: Health Sciences, University of York Ringgold Standard Institution, York, UK Bradford District Care NHS Foundation Trust, Bradford, UK.
authors.forename: Najma
authors.initials: N
authors.lastname: Siddiqi
authors.affiliation: School of Health Sciences, University of East Anglia Ringgold Standard Institution, Norwich, Norfolk, UK.
authors.forename: Francine
authors.initials: F
authors.lastname: Cheater
authors.affiliation: Leeds Institute for Clinical Trials Research, University of Leeds Ringgold Standard Institution, Leeds, UK.
authors.forename: Michelle
authors.initials: M
authors.lastname: Collinson
authors.affiliation: Leeds Institute for Clinical Trials Research, University of Leeds Ringgold Standard Institution, Leeds, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Farrin
authors.affiliation: Academic Unit of Elderly Care and Rehabilitation, Bradford Institute for Health Sciences, University of Leeds, Bradford, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Forster
authors.affiliation: Bradford District Care NHS Foundation Trust, Bradford, UK.
authors.forename: Deepa
authors.initials: D
authors.lastname: George
authors.affiliation: Academic Unit of Elderly Care and Rehabilitation, Leeds Institute of Health Sciences, Leeds, West Yorkshire, UK.
authors.forename: Mary
authors.initials: M
authors.lastname: Godfrey
authors.affiliation: Leeds Institute for Clinical Trials Research, University of Leeds Ringgold Standard Institution, Leeds, UK.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Graham
authors.affiliation: Centre for Cognitive Ageing and Cognitive Epidemiology, University of Edinburgh, Edinburgh, UK.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Harrison
authors.affiliation: Academic Unit of Elderly Care and Rehabilitation, Bradford Institute for Health Research Ringgold Standard Institution, Bradford, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Heaven
authors.affiliation: Leeds Institute for Clinical Trials Research, University of Leeds Ringgold Standard Institution, Leeds, UK.
authors.forename: Peter
authors.initials: P
authors.lastname: Heudtlass
authors.affiliation: Academic Unit of Health Economics, University of Leeds Ringgold Standard Institution, Leeds, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Hulme
authors.affiliation: Academic Unit of Health Economics, University of Leeds Ringgold Standard Institution, Leeds, UK.
authors.forename: David
authors.initials: D
authors.lastname: Meads
authors.affiliation: Bradford District Care NHS Foundation Trust, Bradford, UK.
authors.forename: Chris
authors.initials: C
authors.lastname: North
authors.affiliation: Bradford District Care NHS Foundation Trust, Bradford, UK.
authors.forename: Angus
authors.initials: A
authors.lastname: Sturrock
authors.affiliation: Academic Unit of Elderly Care and Rehabilitation, Bradford Institute for Health Research Ringgold Standard Institution, Bradford, UK.
authors.forename: John
authors.initials: J
authors.lastname: Young
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control / Q000706:statistics & numerical data; D000368:Aged; D003693:Delirium / Q000517:prevention & control*; D005240:Feasibility Studies; D005260:Female; D017048:Health Care Costs / Q000706:statistics & numerical data; D006282:Health Personnel / Q000193:education; D006707:Homes for the Aged / Q000191:economics / Q000458:organization & administration; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008134:Long-Term Care / Q000191:economics / Q000379:methods; D008297:Male; D011788:Quality of Life; D012307:Risk Factors
keywords: cluster randomized trial; delirium; long-term care; older people; prevention