Condition category
Mental and Behavioural Disorders
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
22/11/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof John Young

ORCID ID

Contact details

The Academic Unit of Elderly Care and Rehabilitation

Duckworth Lane
Bradford
BD9 6RJ
United Kingdom

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

http://www.york.nhs.uk/

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

  1. 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.

Additional files

Editorial Notes