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
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)?
Scientific title
What is the functional outcome of Intensive Care (ICU) survivors utilizing the Acute Care Index of Function (ACIF)?
Secondary ID [1] 301204 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
critically ill 317350 0
intensive care survivors 317783 0
Condition category
Condition code
Public Health 315457 315457 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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
Intervention code [1] 317505 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323703 0
Acute Care Index of Function Score, which is a measure of global function
Timepoint [1] 323703 0
ICU discharge and hospital discharge
Secondary outcome [1] 382654 0
discharge destination (home, other acute care facility, rehabilitation facility, death) from hospital records
Timepoint [1] 382654 0
Hospital discharge
Secondary outcome [2] 382655 0
12 month mortality data from Australian Institute of Health and Wellfare
Timepoint [2] 382655 0
12 months post hospital discharge
Secondary outcome [3] 382656 0
In hospital mortality from ANZICs data base
Timepoint [3] 382656 0
Hospital Discharge
Secondary outcome [4] 382657 0
Readmission to ICU from ANZICs data base
Timepoint [4] 382657 0
Hospital discharge

Eligibility
Key inclusion criteria
admitted Canberra Hospital ICU 1 July 2018-30 June 2019
Required 72 hours or more of ICU care
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
transferred to another ICU for ongoing acute care
insufficient Data to complete both ICU and hospital discharge ACIF

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
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

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
20/12/2019
Date of last participant enrolment
Anticipated
Actual
20/12/2019
Date of last data collection
Anticipated
10/08/2020
Actual
Sample size
Target
600
Accrual to date
Final
715
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 16608 0
The Canberra Hospital - Garran
Recruitment postcode(s) [1] 30204 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 305653 0
University
Name [1] 305653 0
Australian National University
Country [1] 305653 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
Acton, Australian Capital Territory 2600
Country
Australia
Secondary sponsor category [1] 306060 0
Hospital
Name [1] 306060 0
Canberra Hospital
Address [1] 306060 0
Yamba Drive Garran, Australian Capital Territory 2605
Country [1] 306060 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305936 0
Canberra Hospital Human Ethics Committee
Ethics committee address [1] 305936 0
Ethics committee country [1] 305936 0
Australia
Date submitted for ethics approval [1] 305936 0
28/10/2019
Approval date [1] 305936 0
02/12/2019
Ethics approval number [1] 305936 0
2019.LRE.00216
Ethics committee name [2] 305939 0
Australian National University Human Ethics Committee
Ethics committee address [2] 305939 0
Ethics committee country [2] 305939 0
Australia
Date submitted for ethics approval [2] 305939 0
11/01/2019
Approval date [2] 305939 0
20/01/2020
Ethics approval number [2] 305939 0
2019/958

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

Contacts
Principal investigator
Name 102130 0
Mr Vincenzo Marzano
Address 102130 0
Australian National University
Acton, ACT 2600
Country 102130 0
Australia
Phone 102130 0
+61 410658181
Fax 102130 0
Email 102130 0
vince.marzano@act.gov.au
Contact person for public queries
Name 102131 0
Vincenzo Marzano
Address 102131 0
Australian National University
Acton, ACT 2600
Country 102131 0
Australia
Phone 102131 0
+61 410658181
Fax 102131 0
Email 102131 0
vince.marzano@act.gov.au
Contact person for scientific queries
Name 102132 0
Vincenzo Marzano
Address 102132 0
Australian National University
Acton, ACT 2600
Country 102132 0
Australia
Phone 102132 0
+61 410658181
Fax 102132 0
Email 102132 0
vince.marzano@act.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all deidentified data will be available
When will data be available (start and end dates)?
commencing 12 months post publication with no end date
Available to whom?
reviewers and other researchers
Available for what types of analyses?
re analysis or subgroup analaysis
How or where can data be obtained?
contacting the chief investigator via email (vince.marzano@act.gov.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7865Study protocol  vince.marzano@act.gov.au 379768-(Uploaded-06-05-2020-10-44-55)-Study-related document.doc
7866Statistical analysis plan  vince.marzano@act.gov.au
7867Ethical approval  vince.marzano@act.gov.au
7868Analytic code  vince.marzano@act.gov.au
7869Clinical study report  vince.marzano@act.gov.au



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.