Pilot Trial of "Stop Delirium!" | Not Recruiting
Pilot Trial of "Stop Delirium!"
PiTSTOP
Trial Source

Health Conditions
  • Delirium
Not Recruiting
Recruitment Status
ISRCTN27972532
Primary Trial ID Number
Summary
Does a multicomponent intervention ‘Stop Delirium!' Prevent Delirium in Care Homes for Older People? Delirium (or acute confusion) is a serious illness common in older people, in which a person’s thinking and perceptions may be affected. Reducing delirium is important because of the considerable distress it causes and the poor outcomes associated with it e.g. falls, hospital admissions, mortality and costs to the NHS. Preventing delirium is possible using multi-component interventions; successful interventions in hospitals have reduced it by one third. However, there is little research to guide practice in care homes. In previous work we developed a multi-component intervention, called "Stop Delirium!", based on what is already known. from the research literature on preventing delirium; and on strategies to change professionals’ practice. We found Stop Delirium! was acceptable to care home staff and had potential to improve care and to improve outcomes for residents. We have yet to find out if it can prevent delirium and whether the additional costs are justified. Before starting on a large costly trial of Stop Delirium!, we plan to carry out a pilot that will test and help improve the design of the main trial. We will select 12 care homes; 6 will be randomised to receive Stop Delirium! over 16 months and 6 to usual care. We will collect data by administering tests to residents, examining their health records and interviewing staff. We will obtain key information e.g rates of recruitment to the study, appropriateness of our proposed methods to measure outcomes, burden of assessments for residents, that will help to plan the main study. This pilot study will provide information that will allow a full trial. It will also help implement recent national (NICE) delirium guidelines, which recommend multi-component interventions for delirium prevention in care homes. More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12105
Primary Outcome Measures
  • Presence of delirium on any day during a 1 month post intervention period. Researchers will examine residents on alternate days (except Sundays).
Secondary Outcome Measures
  • Delirium severity (proportion of residents with DRS-R-98 severity scale score >15.25 at any assessment) during the 1 month post intervention period
Research Question
  • Does a multicomponent intervention ‘Stop Delirium!' Prevent Delirium in Care Homes for Older People? Delirium (or acute confusion) is a serious illness common in older people, in which a person’s thinking and perceptions may be affected. Reducing delirium is important because of the considerable distress it causes and the poor outcomes associated with it e.g. falls, hospital admissions, mortality and costs to the NHS. Preventing delirium is possible using multi-component interventions; successful interventions in hospitals have reduced it by one third. However, there is little research to guide practice in care homes. In previous work we developed a multi-component intervention, called "Stop Delirium!", based on what is already known. from the research literature on preventing delirium; and on strategies to change professionals’ practice. We found Stop Delirium! was acceptable to care home staff and had potential to improve care and to improve outcomes for residents. We have yet to find out if it can prevent delirium and whether the additional costs are justified. Before starting on a large costly trial of Stop Delirium!, we plan to carry out a pilot that will test and help improve the design of the main trial. We will select 12 care homes; 6 will be randomised to receive Stop Delirium! over 16 months and 6 to usual care. We will collect data by administering tests to residents, examining their health records and interviewing staff. We will obtain key information e.g rates of recruitment to the study, appropriateness of our proposed methods to measure outcomes, burden of assessments for residents, that will help to plan the main study. This pilot study will provide information that will allow a full trial. It will also help implement recent national (NICE) delirium guidelines, which recommend multi-component interventions for delirium prevention in care homes. More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12105
Design Type
Sorry, this information is not available
Ethics Approval
ref: 12/YH/0018
Publications
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24495514
Countries of Recruitment
United Kingdom
Participant Sex
Both
Participant Age Range
Senior
Participant Type
Patient
Trial Sample Size
288
Participant Inclusion Criteria
  • Care Homes
  • 1. Care homes for older people in Bradford
  • 2. Run by an independent provider (private, voluntary or non profit-making)
  • 3. Managers expressing an interest for their care home to participate in the study
  • 4. Providing nursing care
  • 5. Within catchment area for the City and North Bradford District NHS Care Trust Older People’s Community Mental Health Teams.
  • Residents:
  • 1. All people resident in the 12 study care homes during recruitment period recruitment
  • 2. Male and female participants
  • 3. Lower Age Limit 60 years
Participant Exclusion Criteria
  • Care Homes:
  • 1. Local Authority homes
  • 2. Residential homes
  • 3. Specialist homes, except those specialising in providing dementia care
  • 4. Care homes involved in other projects likely to impact on study e.g initiatives to reduce hospital admissions
  • Residents
  • 1. Unable to participate in assessments because of severe communication difficulties or severe dementia.
  • 2. Receiving end of life care
  • 3. Non-English speakers
Interventions
Input from a Specialist Delirium Practitioner over a 16 month period comprised 3x education sessions and monthly working groups. Delirium Practitioner work is supported by a Toolkit, Manual and learning resources i.e. 'Delirium box' The development of a Delirium Champion in the care home. The methodology for the control arm is care as usual.
Design Details
Sorry, this information is not available
Study Design
Randomised; Interventional; Design type: Treatment
Results Reporting
Sorry, this information is not available
Acronym
PiTSTOP
Scientific Title
A cluster randomised controlled pilot trial of 'Stop Delirium!' a complex intervention to prevent delirium in care homes for older people
Secondary Trial Identifying Number
12105
Website
Sorry, this information is not available
Study Funded By
NIHR Research for Patient Benefit Programme (UK) ref: PB-PG-0610-22068
Funder Type
Sorry, this information is not available
Study Sponsored By
Bradford District Care Trust (UK)
Study Also Sponsored By
Sorry, this information is not available
Primary Sponsor Type
Sorry, this information is not available
Secondary Sponsor Type
Sorry, this information is not available
Key Dates

Date of First Enrollment

26 Mar 2012

Recruitment End Date

31 Mar 2014

Trial End Date

31 Mar 2014

Date added to Registry

17 May 2012

Last Updated

06 Feb 2014