Plain English Summary
Background and study aims
Delirium is a state of mental confusion that can happen if you become medically unwell. The aim of this study is to investigate whether a simple screening tool for delirium, which has been shown to be reliable in the detection of delirium in the hospital setting, might be useful for detecting delirium as part of routine care in (UK) care homes, and whether it can be used to assess delirium severity.
Who can participate?
All individuals aged over 65 resident in participating care homes
What does the study involve?
Participating care home residents from four care homes in Leeds/Bradford will be assessed daily for delirium with the Delirium Observation Screening Scale (DOSS). The diagnostic accuracy of the DOSS for the detection of delirium will be tested against the Confusion Assessment Method completed by trained research assistants. Data collection will occur over nine months.
What are the possible benefits and risks of participating?
A reliable method of routine delirium detection in care homes may reduce the impact of an episode of delirium on individuals, their families, and care home staff, offering substantial benefits for the health economy and the wider NHS. Reliable detection of delirium in long-term care settings could form the basis for future delirium research and make delirium a feasible outcome measure for frail older people in this setting.
Where is the study run from?
Bradford Royal Infirmary (UK)
When is the study starting and how long is it expected to run for?
February 2015 to April 2016
Who is funding the study?
Bradford Teaching Hospitals NHS Foundation Trust (UK)
Who is the main contact?
Satti Saggu
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18279
Study information
Scientific title
Investigation of the Delirium Observation Screening Scale (DOSS) for the routine detection of delirium in the Care Home Setting: the DOSS study
Acronym
Study hypothesis
The aim of this study is to investigate whether a simple screening tool for delirium, that has been shown to be reliable in the detection of delirium in the hospital setting, might have utility in the detection of delirium as part of routine care in (UK) care homes, and whether it can be used to assess delirium severity.
Ethics approval
NRES Committee Yorkshire & The Humber - Leeds West, 31/10/2014, ref: 14/YH/1174
Study design
Non-randomised; Observational; Design type: Qualitative
Primary study design
Observational
Secondary study design
Qualitative
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Ageing; Subtopic: Ageing; Disease: All Ageing
Intervention
Participating care home residents from four care homes in Leeds/Bradford will be assessed daily for delirium with the DOSS. Diagnostic accuracy of the DOSS for the detection of delirium will be tested against the Confusion Assessment Method completed by trained research assistants. Data collection will occur over 9 months.
Intervention type
Other
Phase
Drug names
Primary outcome measure
To determine how the DOSS performs as a screening instrument for delirium when administered by care home staff as part of routine care in UK care homes in comparison to the research standard the CAM (Confusion Assessment Method)
Secondary outcome measures
1. To investigate the feasibility of routine daily administration of a delirium screening tool by care home staff in the long-term care setting
2. To determine whether the DOSS may be used as a measure of delirium severity
3. To examine, through item response theory, the psychometric properties and scalability of the 25-item DOSS and to determine whether a shorter, care home specific DOSS may be identified
Overall trial start date
23/02/2015
Overall trial end date
29/04/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All individuals aged over 65 resident in participating care homes
Target Gender: Male & Female; Lower Age Limit 65 years
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned Sample Size: 258; UK Sample Size: 258
Participant exclusion criteria
1. Residents approaching end of life (within three months) or in receipt of palliative care (as advised by care home staff)
2. Residents unwilling to provide informed consent
3. Residents lacking capacity to consent to recruitment, for whom a consultee declaration for participation cannot be obtained
4. Residents with an advance decision or statement against participation in research
Recruitment start date
23/02/2015
Recruitment end date
15/05/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Bradford Royal Infirmary
Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research Central Commissioning Facility
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Pending publications:
1. Teale EA, Young J, Siddiqi N, Munyombwe T, Schuurmans M. Feasibility and diagnostic test accuracy of the Delirium Observation Screening Scale for routine detection of delirium in UK care homes
2. Teale EA, Young J, Siddiqi N, Munyombwe T, Harrison J, Schuurmans M. Scaling properties of the Delirium Observation Screening Scale in UK care-homes: development of the Care Home-DOSS (CH-DOSS)
3. Teale EA, Munyombwe T. Measuring delirium severity with the CH-DOSS: a latent profile analysis
IPD sharing statement:
The datasets generated during and/or analysed during the current study is not expected to be made available because the trialists do not have participant consent for the sharing of the data outside the research team, and receiving the regulatory approvals and retrospective consent would be difficult with this particular cohort of patients
Intention to publish date
30/04/2017
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
1. 2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27324706
2. Routine detection of delirium in UK care homes: preliminary results from the DOSS study. Teale EA, Young J, Siddiqi N, Munyombwe T, Schuurmans M. European Delirium Association Conference, Portugal November 2016 (Abstract)