Condition category
Not Applicable
Date applied
13/02/2015
Date assigned
12/03/2015
Last edited
12/03/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
From 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

Contact information

Type

Scientific

Primary contact

Mr Satti Saggu

ORCID ID

Contact details

Bradford Royal Infirmary
Duckworth Lane
Bradford
West Yorkshire
BD9 6RJ
United Kingdom

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

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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 measures

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

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

Sponsor information

Organisation

Bradford Teaching Hospitals NHS Foundation Trust

Sponsor details

Duckworth Lane
Bradford
West Yorkshire
BD9 6RJ
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

To be confirmed at a later date

Intention to publish date

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes