title: Protocol for REducing Anti-Psychotic use in residential care-Huntington Disease (REAP-HD): a pilot cluster randomised controlled trial of a multifaceted intervention for health professionals.
abstract: BACKGROUND
  Antipsychotics are commonly used for management of behavioural symptoms in dementia, among people in residential care. This continues to occur despite their modest effectiveness, potential harms including increased risk of death and stroke, and absence of detrimental effect when people with dementia were randomised to antipsychotic withdrawal. This study aims to test the hypothesis that the multifaceted REducing Anti-Psychotic use in residential care-Huntington Disease (REAP-HD) programme is more effective than standard staff education (SSE) in reducing antipsychotic use for people with HD in residential care facilities (RCF).
  
  
  METHODS
  this is a cluster randomised controlled trial with blinded outcome assessment. The study population is healthcare professionals looking after people with HD in individual RCF, in the state of New South Wales. Each RCF will be centrally randomised to the REAP-HD programme or the comparator, SSE. Blinded outcome assessment will be performed by examining drug charts and using the Neuropsychiatric Inventory-Q (NPI-Q). Primary outcome is the proportion of people with HD who have had a reduction in antipsychotic use 4 months after the intervention. Secondary outcome measures are (1) change in severity of behavioural symptoms, as measured by the NPI-Q at 4 months (to ensure antipsychotic reduction has not lead to worsening behavioural symptoms), and (2) proportion of people with HD who have had a reduction in antipsychotic dosage at 4 months for each strategy, compared to 4 months prior to enrolment (to capture the possibility that both arms reduced antipsychotic use). Analysis will be by Intention-To-Treat and take into account the clustering. Recruitment is ongoing, as of July 2014.
  
  
  BACKGROUND
  This protocol has been approved by the Western Sydney Local Health District Human Research Ethics Committee, trial registration ACTRN12614000083695. Study results will be disseminated through peer-reviewed publication in an anonymous manner.
  
  
  BACKGROUND
  ACTRN12614000083695, the Australian New Zealand Clinical Trials Registry.
authors.affiliation: Huntington Disease Service, Westmead Hospital, Westmead, New South Wales, Australia The University of Sydney, Sydney, New South Wales, Australia.
authors.forename: Clement T
authors.initials: CT
authors.lastname: Loy
authors.affiliation: The University of New South Wales, Kensington, New South Wales, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Hayen
authors.affiliation: Huntington Disease Service, Westmead Hospital, Westmead, New South Wales, Australia.
authors.forename: Colleen
authors.initials: C
authors.lastname: McKinnon
mesh_terms: D014150:Antipsychotic Agents / Q000008:administration & dosage*; D001291:Attitude of Health Personnel; D016000:Cluster Analysis; D006282:Health Personnel / Q000193:education*; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy* / Q000453:epidemiology; D009517:New South Wales / Q000453:epidemiology; D017063:Outcome Assessment, Health Care / Q000379:methods*; D010865:Pilot Projects; D015995:Prevalence; D012112:Residential Facilities; D012114:Residential Treatment / Q000379:methods*
chemical_list: D014150:Antipsychotic Agents