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Research Question
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Does a multicomponent intervention ‘Stop Delirium!' Prevent Delirium in Care Homes for Older People?
Cluster Randomised Controlled Pilot Trial.
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. (from UKCRN Portfolio)
Additional lay summaries...
Lay summary under review 1 (from ISRCTN)
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Ethics Approval
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ref: 12/YH/0018
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Study Design
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Randomised; Interventional; Design type: Treatment
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Design Type
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Sorry, not currently available
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Design Details
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Sorry, not currently available
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Health Condition(s) or Problem
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Delirium
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Participants Inclusion Criteria
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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
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Participants Exclusion Criteria
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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
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Participant Sex
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Sorry, not currently available
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Participant Age Range
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Sorry, not currently available
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Participant Type
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Sorry, not currently available
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Target Sample Size
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UK Sample Size: 288;
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Date of First Enrolment
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Sorry, not currently available
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Date of Recruitment End
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Sorry, not currently available
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Date of End of Follow-up
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Sorry, not currently available
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Trial End Date
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Sorry, not currently available
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Recruitment Status
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Recruiting
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Overall Trial Status
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Sorry, not currently available
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Countries of Recruitment
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United Kingdom
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Nation
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England
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Location
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Leeds
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Interventions
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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.
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Primary Outcome Measures
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Presence of delirium on any day during a 1 month post intervention period. Researchers will examine residents on alternate days (except Sundays).
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Secondary Outcome Measures
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Delirium severity (proportion of residents with DRS-R-98 severity scale score >15.25 at any assessment) during the 1 month post intervention period
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Website
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Sorry, not currently available
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