Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000204347
Ethics application status
Approved
Date submitted
7/03/2008
Date registered
16/04/2008
Date last updated
16/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prevention and Management of Delirium in Older General Medical Patients
Scientific title
A Multidisciplinary Intervention Implementing Clinical Practice Guidelines for the Prevention and Management of Delirium in Older Acute General Medical Patients
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Delirium 2912 0
Condition category
Condition code
Neurological 3047 3047 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients with established delirium or an intermediate-high risk assessment will be identified through early screening and fast tracked from the Emergency Department to the intervention ward. The intervention ward will be modified to provide an appropriate sensory environment. The intervention will be administered by the existing multidisciplinary team and will be in line with Clinical Practice Guidelines for the prevention and treatment of delirium. Patients will undergo comprehensive medical, nursing and allied health assessment with regard to modifiable risk factors. Nursing assistants, volunteers and carers will assist in re-orientation and distraction therapy. The intervention will continue for the duration of the patient's admission.
Intervention code [1] 2642 0
Early detection / Screening
Intervention code [2] 2643 0
Prevention
Intervention code [3] 2644 0
Treatment: Other
Comparator / control treatment
Standard treatment involves medical care plus early allied health referral and assessment of risks pertaining to discharge planning.
Control group
Active

Outcomes
Primary outcome [1] 3929 0
Overall incidence delirium will be measured by applying the Confusion Assessment Method (CAM)
Timepoint [1] 3929 0
At 48 hours, prior to discharge
Secondary outcome [1] 6608 0
Time to resolution of delirium will be measured by applying the Confusion Assessment Method (CAM) at intervals and documenting days to resolution of delirium
Timepoint [1] 6608 0
Day 4,7; weekly until patient discharge
Secondary outcome [2] 6609 0
Length of stay
Timepoint [2] 6609 0
Discharge
Secondary outcome [3] 6610 0
Documented falls
Timepoint [3] 6610 0
Discharge
Secondary outcome [4] 6611 0
Cognitive decline will be measured by applying either Abbreviated Mental Test (AMT) or Mini-Mental State Examination (MMSE) and functional decline through application of a modified Katz Activities of Daily Living (ADL) assessment
Timepoint [4] 6611 0
Admission, discharge

Eligibility
Key inclusion criteria
Patients are eligible for study if admitted to participating medical units; aged 65 years or greater; and at intermediate-high risk of delirium following application of screening tool.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliative patients; combative/dangerous behaviour; hyperactive delirium requiring AIN special >4 hours daily; non invasive ventilation/tracheostomy; post ICU; severe psychiatric disorder preventing participation in interventions; severe dementia; discharge anticipated within 72 hours admission; aphasia; any condition not listed above that prevents participation in intervention ward programme

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
406
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 598 0
4029

Funding & Sponsors
Funding source category [1] 3165 0
Government body
Name [1] 3165 0
Strengthening Aged Care
Country [1] 3165 0
Australia
Primary sponsor type
Individual
Name
Dr Catherine Maussen
Address
Staff Specialist Internal Medicine
Level 3
James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 2838 0
Individual
Name [1] 2838 0
Dr Charles Denaro
Address [1] 2838 0
Director Internal Medicine
Level 3
James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country [1] 2838 0
Australia
Secondary sponsor category [2] 2839 0
Individual
Name [2] 2839 0
Dr Alison Mudge
Address [2] 2839 0
Staff Specialist Internal Medicine
Level 3
James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country [2] 2839 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5145 0
Human Research Ethics Committee
Ethics committee address [1] 5145 0
Ethics committee country [1] 5145 0
Australia
Date submitted for ethics approval [1] 5145 0
Approval date [1] 5145 0
09/01/2008
Ethics approval number [1] 5145 0
EC001720

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28428 0
Address 28428 0
Country 28428 0
Phone 28428 0
Fax 28428 0
Email 28428 0
Contact person for public queries
Name 11585 0
Ms Karen-Lee Steere Project Manager
Address 11585 0
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country 11585 0
Australia
Phone 11585 0
+61 7 36365789
Fax 11585 0
Email 11585 0
[email protected]
Contact person for scientific queries
Name 2513 0
Dr Catherine Maussen
Address 2513 0
Staff Specialist Internal Medicine
Level 3
James Mayne Building
Royal Brisbane and Women's Hospital
Butterfield St
Herston QLD 4029
Country 2513 0
Australia
Phone 2513 0
+61 7 36367678
Fax 2513 0
Email 2513 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.