Delirium Prevention Study
| ISRCTN | ISRCTN55767124 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55767124 |
| Secondary identifying numbers | 4951 |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 22/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof John Young
Scientific
Scientific
The Academic Unit of Elderly Care and Rehabilitation
, Duckworth Lane
Bradford
BD9 6RJ
United Kingdom
Study information
| Study design | Non-randomised interventional and observational prevention cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Comparative study of a standardised care system to prevent delirium |
| Study objectives | 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(s) | Bradford REC, 18/09/2007, ref: 07/H1302/73 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 05/10/2007 |
| Completion date | 30/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 500; UK Sample Size: 500 |
| Key inclusion criteria | Admitted to one of study elderly care wards |
| Key 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 |
| Date of first enrolment | 05/10/2007 |
| Date of final enrolment | 30/01/2009 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The Academic Unit of Elderly Care and Rehabilitation
Bradford
BD9 6RJ
United Kingdom
BD9 6RJ
United Kingdom
Sponsor information
York Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Learning and Research Centre
Wigginton Road
York
YO31 8HE
England
United Kingdom
| Website | http://www.york.nhs.uk/ |
|---|---|
"ROR" |
https://ror.org/027e4g787 |
Funders
Funder type
Charity
Research into Ageing (UK) (ref: 293)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2013 | Yes | No |
