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Trial Review
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Trial registered on ANZCTR
Registration number
ACTRN12620000791932
Ethics application status
Approved
Date submitted
6/05/2020
Date registered
6/08/2020
Date last updated
6/08/2020
Date data sharing statement initially provided
6/08/2020
Date results information initially provided
6/08/2020
Type of registration
Retrospectively registered
Titles & IDs
Public title
What is the functional outcome of Intensive Care (ICU) survivors utilizing the Acute Care Index of Function (ACIF)?
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Scientific title
What is the functional outcome of Intensive Care (ICU) survivors utilizing the Acute Care Index of Function (ACIF)?
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Secondary ID [1]
301204
0
None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
critically ill
317350
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intensive care survivors
317783
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Condition category
Condition code
Public Health
315457
315457
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0
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Other public health
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
retrospective calculation of the Acute Care Index of Function from physiotherapy and nursing notes
Data collected includes demographic (age, sex, admission diagnosis), APACHE II, comorbidities, SOFA score on admission and Day 3, clinical frailty score, CAM ICU, highest ICU Mobility scale, total mechanical ventilation time, total non invasive ventilation time, total number of renal replacement days, cumulative drug doses (opioid, vasoactive, antipsychotic,benzodiazepines, neuromuscular blockades, corticosteroids) ICU length of stay, Hospital length of stay, discharge destination, FIM on care-type change and discharge to rehab facility or care facility, 12 month mortality.
Data will be extracted from the ANZICs data base and electronic patient records for patients admitted to Canberra Hospital ICU from July 1 2018 to June 30 2019. Mortality data for 12 months post ICU will be sourced from the Australian Institute of Health and Wellfare
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Intervention code [1]
317505
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
323703
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Acute Care Index of Function Score, which is a measure of global function
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Assessment method [1]
323703
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Timepoint [1]
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ICU discharge and hospital discharge
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Secondary outcome [1]
382654
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discharge destination (home, other acute care facility, rehabilitation facility, death) from hospital records
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Assessment method [1]
382654
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Timepoint [1]
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Hospital discharge
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Secondary outcome [2]
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12 month mortality data from Australian Institute of Health and Wellfare
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Assessment method [2]
382655
0
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Timepoint [2]
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12 months post hospital discharge
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Secondary outcome [3]
382656
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In hospital mortality from ANZICs data base
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Assessment method [3]
382656
0
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Timepoint [3]
382656
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Hospital Discharge
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Secondary outcome [4]
382657
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Readmission to ICU from ANZICs data base
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Assessment method [4]
382657
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Timepoint [4]
382657
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Hospital discharge
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Eligibility
Key inclusion criteria
admitted Canberra Hospital ICU 1 July 2018-30 June 2019
Required 72 hours or more of ICU care
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
transferred to another ICU for ongoing acute care
insufficient Data to complete both ICU and hospital discharge ACIF
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Study design
Purpose
Natural history
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Duration
Cross-sectional
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
As this is a cohort study over a defined period of time, there is no statistical assumptions regarding sample size
Data will be extracted and organized in excel spreadsheets with all variables defined and a data dictionary established. Patient outcomes will be reported with descriptive statistics. Multiple regression models will be used to explore the relationships between functional measures (ACIF) (dependent variable) and length of stay, discharge destination, and clinical subpopulations. Survival analysis will be used if time to event data can be analyzed. Comparisons between groups will be performed with Pearsons’ Chi-square, t-test, ANOVA and their non-parametric equivalents. These models will be adjusted for demographic factors such as age, sex, clinical frailty and comorbidity. Medical interventions will be categorized, and their effect will be modelled with ACIF and length of stay as the dependent variables. At this point significance will be accepted where p < 0.05 in line with current research practices
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
20/12/2019
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Date of last participant enrolment
Anticipated
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Actual
20/12/2019
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Date of last data collection
Anticipated
10/08/2020
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Actual
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Sample size
Target
600
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Accrual to date
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Final
715
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Recruitment in Australia
Recruitment state(s)
ACT
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Recruitment hospital [1]
16608
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The Canberra Hospital - Garran
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Recruitment postcode(s) [1]
30204
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2605 - Garran
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Australian National University
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Address [1]
305653
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Acton, ACT 2600
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Country [1]
305653
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Australia
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Primary sponsor type
University
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Name
Australian National University
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Address
Acton, Australian Capital Territory 2600
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Canberra Hospital
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Address [1]
306060
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Yamba Drive Garran, Australian Capital Territory 2605
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Country [1]
306060
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
305936
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Canberra Hospital Human Ethics Committee
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Ethics committee address [1]
305936
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Yamba Drive Garran, ACT, 2605
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Ethics committee country [1]
305936
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Australia
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Date submitted for ethics approval [1]
305936
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28/10/2019
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Approval date [1]
305936
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02/12/2019
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Ethics approval number [1]
305936
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2019.LRE.00216
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Ethics committee name [2]
305939
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Australian National University Human Ethics Committee
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Ethics committee address [2]
305939
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Acton, ACT 2600
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Ethics committee country [2]
305939
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Australia
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Date submitted for ethics approval [2]
305939
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11/01/2019
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Approval date [2]
305939
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20/01/2020
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Ethics approval number [2]
305939
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2019/958
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Summary
Brief summary
A retrospective observational study to determine the outcomes of ICU survivors measured by the Acute Care Index of Function (ACIF) and determining factors that may effect outcome. The hypotheses for this study are:
• That ACIF scores at ICU discharge will predict physical function and discharge destination at hospital discharge
• That a relationship exists between patient factors and severity of illness on functional outcome measured by the ACIF at hospital discharge
• That the ACIF is a valid tool to measure the functional outcome of ICU survivors
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Mr Vincenzo Marzano
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Address
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Australian National University
Acton, ACT 2600
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Country
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Australia
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Phone
102130
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+61 410658181
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Fax
102130
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Email
102130
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[email protected]
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Contact person for public queries
Name
102131
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Mr Vincenzo Marzano
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Address
102131
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Australian National University
Acton, ACT 2600
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Country
102131
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Australia
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Phone
102131
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+61 410658181
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Fax
102131
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Email
102131
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[email protected]
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Contact person for scientific queries
Name
102132
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Mr Vincenzo Marzano
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Address
102132
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Australian National University
Acton, ACT 2600
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Country
102132
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Australia
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Phone
102132
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+61 410658181
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Fax
102132
0
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Email
102132
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
all deidentified data will be available
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When will data be available (start and end dates)?
commencing 12 months post publication with no end date
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Available to whom?
reviewers and other researchers
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Available for what types of analyses?
re analysis or subgroup analaysis
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How or where can data be obtained?
contacting the chief investigator via email (
[email protected]
)
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
7865
Study protocol
[email protected]
379768-(Uploaded-06-05-2020-10-44-55)-Study-related document.doc
7866
Statistical analysis plan
[email protected]
7867
Ethical approval
[email protected]
7868
Analytic code
[email protected]
7869
Clinical study report
[email protected]
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.
Download to PDF