Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000978369p
Ethics application status
Submitted, not yet approved
Date submitted
3/07/2017
Date registered
6/07/2017
Date last updated
6/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Measuring cognitive function at admission to hospital: the first step towards reducing delirium.
Scientific title
Towards a reduction in delirium in our surgical patients: implementation metrics from step one of the Australian Council for Safety and Quality in Health Care (ACSQHC) Delirium Clinical Care Standard.
Secondary ID [1] 292335 0
None
Universal Trial Number (UTN)
U1111-1198-6742
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Cognitive dysfunction 303882 0
Delirium 303933 0
Condition category
Condition code
Surgery 303244 303244 0 0
Other surgery
Anaesthesiology 303245 303245 0 0
Other anaesthesiology
Mental Health 303287 303287 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Administration of two cognitive function tests, the 4AT and the MoCA, to preoperative patients over the age of 65 years at the time of admission to the ward or preoperative area.
Test will be administered by trained nursing staff.
Primary aim is measurement of rate of cognitive dysfunction.
Quantitative data about patient demographics, time taken to complete the tests, rates of test completion and acceptability the test for the patient will be collected.
Qualitative data will be gathered from nurses and patients about difficulties in test completion.
Intervention code [1] 298514 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 302624 0
Percentage of patients positive for cognitive dysfunction on 4AT and MoCA validated screening tools
Timepoint [1] 302624 0
Single time point at time of admission to ward or preoperative area.
Secondary outcome [1] 336546 0
Time to complete the 4AT and time to complete the MoCA
Timepoint [1] 336546 0
At single time point of test administration

Eligibility
Key inclusion criteria
Operative patients over the age of 65 years
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non english speaking with no interpreter available

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Simple rate calculation

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2017
Actual
Date of last participant enrolment
Anticipated
30/11/2017
Actual
Date of last data collection
Anticipated
30/11/2017
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 8469 0
St Vincent's Private Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [2] 8470 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 16553 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 296883 0
Other
Name [1] 296883 0
St Vincent's Health Australia
Country [1] 296883 0
Australia
Primary sponsor type
Other
Name
St Vincent's Health Australia
Address
Level 5, 340 Albert St, East Melbourne, VIC 3002
Country
Australia
Secondary sponsor category [1] 295889 0
None
Name [1] 295889 0
Address [1] 295889 0
Country [1] 295889 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298103 0
St Vincent's Hospital, Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 298103 0
97-105 Boundary St, Darlinghurst, NSW 2010
Ethics committee country [1] 298103 0
Australia
Date submitted for ethics approval [1] 298103 0
26/06/2017
Approval date [1] 298103 0
Ethics approval number [1] 298103 0

Summary
Brief summary
The ACQSHC introduced the Delirium Clinical Standard to prevent development of delirium in hospital and improvement management.
Implementation of this standard involves educating nursing staff to use a validated cognitive assessment tool at the time of admission for those over the age of 65 years to assess for baseline cognitive decline. If cognitive decline is identified then the patient will be deemed high risk for delirium and daily measurement using a delirium screening tool will occur on the ward so that early treatment can be initiated by a geriatrician.
This project aims to introduce the first step, which is the cognitive decline screening once on admission and measure how long this takes. We will also be asking nurses and patients about how easy and acceptable this process is and collecting some simple basic information about the patient.
This information will be used to guide a broader roll out of the full Clinical Care Pathway.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75998 0
Dr Jennifer Stevens
Address 75998 0
Brian Dwyer Department of Anaesthesia and Pain Medicine
St Vincent's Public Hospital
Darlinghurst
Sydney
NSW 2010
Country 75998 0
Australia
Phone 75998 0
+61 2 8382 3200
Fax 75998 0
Email 75998 0
[email protected]
Contact person for public queries
Name 75999 0
Dr Jennifer Stevens
Address 75999 0
Brian Dwyer Department of Anaesthesia and Pain Medicine
St Vincent's Public Hospital
Darlinghurst
Sydney
NSW 2010
Country 75999 0
Australia
Phone 75999 0
+61 2 8382 3200
Fax 75999 0
Email 75999 0
[email protected]
Contact person for scientific queries
Name 76000 0
Dr Jennifer Stevens
Address 76000 0
Brian Dwyer Department of Anaesthesia and Pain Medicine
St Vincent's Public Hospital
Darlinghurst
Sydney
NSW 2010
Country 76000 0
Australia
Phone 76000 0
+61 2 8382 3200
Fax 76000 0
Email 76000 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.