Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
4951
Study information
Scientific title
Comparative study of a standardised care system to prevent delirium
Acronym
Study hypothesis
Delirium is a syndrome of acute, fluctuating confusion, which commonly affects older people who are unwell and is associated with poorer outcomes, but has the potential to be prevented.
The aim of the study is to investigate the effectiveness of a novel, multi-component intervention called the Delirium Prevention System of Care on delirium occurrence in older people admitted to hospital, thereby improving their clinical outcomes.
Ethics approval
Bradford REC, 18/09/2007, ref: 07/H1302/73
Study design
Non-randomised interventional and observational prevention cohort study
Primary study design
Observational
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Dementia; Disease: Dementia
Intervention
Control/before group:
Usual care
Intervention/after group:
Delirium prevention care system - education of all grades of ward staff about delirium and its prevention (education provided by delirium champions), staff modification of prevention protocols, use of multicomponent delirium prevention protocols multiple times a day by all staff, focused on modifying common risk factors for delirium.
Observation detail:
Daily assessments of all recruited participants for delirium using Confusion Assessment Method (CAM)
Study entry: registration only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Incident delirium (measured using Confusion Assessment Method score greater than 2 and Delirium Rating Scale [DRS-R-98] total score greater than 17) by 7 days after study ward admission
Secondary outcome measures
1. Cumulative length of delirium episodes per patient by ward discharge and 6 months after ward discharge
2. Number of delirium episodes per patient by ward discharge and 6 months after ward discharge
Overall trial start date
05/10/2007
Overall trial end date
30/01/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Admitted to one of study elderly care wards
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned Sample Size: 500; UK Sample Size: 500
Participant exclusion criteria
1. Consent or assent is refused
2. Not enrolled within 24 hours of ward admission
3. Patient leaves the ward prior to their first outcome assessment
4. Unable to speak English and there is no translator available
5. Unconscious or dying
6. Aged 73 - 104 years, either sex
Recruitment start date
05/10/2007
Recruitment end date
30/01/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Academic Unit of Elderly Care and Rehabilitation
Bradford
BD9 6RJ
United Kingdom
Sponsor information
Organisation
York Hospitals NHS Foundation Trust (UK)
Sponsor details
Learning and Research Centre
Wigginton Road
York
YO31 8HE
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Research into Ageing (UK) (ref: 293)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23978407
Publication citations
-
Results
Holt R, Young J, Heseltine D, Effectiveness of a multi-component intervention to reduce delirium incidence in elderly care wards., Age Ageing, 2013, 42, 6, 721-727, doi: 10.1093/ageing/aft120.