Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000099820
Ethics application status
Approved
Date submitted
3/12/2020
Date registered
1/02/2021
Date last updated
17/09/2023
Date data sharing statement initially provided
1/02/2021
Date results provided
17/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Patterns and provision of nutrition care in patients who are transferred to inpatient rehabilitation following critical illness: a retrospective observational study
Scientific title
Patterns and provision of nutrition care in patients who are transferred to inpatient rehabilitation following critical illness: a retrospective observational study
Secondary ID [1] 302938 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nutrition care in critical illness 319966 0
Condition category
Condition code
Diet and Nutrition 317900 317900 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This retrospective observational study will observe the nutrition process of care in critically ill patients from Intensive Care Unit (ICU) admission until discharge from inpatient rehabilitation.

Data collection will occur during the admission period of March 2019 – February 2020 (inclusive).

Data collection will stop either at 50 patients or at the end of the study period, whichever occurs first. Data collection will stop upon discharge from inpatient rehabilitation, or after study day 28, whichever occurs first.
Intervention code [1] 319224 0
Not applicable
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325916 0
Number of dietetic reviews
Timepoint [1] 325916 0
Data will be collected from medical records from day 1 of ICU admission until discharge from inpatient rehabilitation (or after study day 28, whichever occurs first) and reported separately for ICU, acute-ward and rehabilitation admissions.
Secondary outcome [1] 389491 0
Time to first nutrition assessment
Timepoint [1] 389491 0
Data will be collected from medical records from day 1 of ICU admission until discharge from inpatient rehabilitation (or after study day 28, whichever occurs first) and reported separately for ICU, acute-ward and rehabilitation admissions.
Secondary outcome [2] 389492 0
Days on enteral nutrition, oral, parenteral nutrition (and combination of modes)
Timepoint [2] 389492 0
Data will be collected from medical records from day 1 of ICU admission until discharge from inpatient rehabilitation, or after study day 28, whichever occurs first.
Secondary outcome [3] 389494 0
Nasogastric tube management including reasons for removal
Timepoint [3] 389494 0
Data will be collected from medical records from day 1 of ICU admission until discharge from inpatient rehabilitation, or after study day 28, whichever occurs first.
Secondary outcome [4] 389495 0
Nutrition impacting symptoms (exploratory outcome)
Timepoint [4] 389495 0
Data will be collected from medical records from day 1 of ICU admission until discharge from inpatient rehabilitation (or after study day 28, whichever occurs first) and reported separately for ICU, acute-ward and rehabilitation admissions.
Secondary outcome [5] 389496 0
Malnutrition Universal Screening Tool (MUST) completion
Timepoint [5] 389496 0
Data will be collected from medical records from day 1 of ICU admission until discharge from inpatient rehabilitation, or after study day 28, whichever occurs first. Data will be reported separately for acute-ward and rehabilitation admissions.
Secondary outcome [6] 389497 0
Diagnosis of malnutrition
Timepoint [6] 389497 0
Data will be collected from medical records from day 1 of ICU admission until discharge from inpatient rehabilitation, or after study day 28, whichever occurs first.

Eligibility
Key inclusion criteria
- 18 years of age or older
- ICU admission at The Alfred Hospital for more than 48 hours with discharge to Caulfield inpatient rehabilitation within 28 days during index hospitalisation admission
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Where death occurred during acute care hospitalisation
- Enrolled in the intervention arm of INTENT (Intensive nutrition therapy compared to usual care in critically ill adults: A randomised pilot trial)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Retrospective
Statistical methods / analysis
A convenience sample of 50 patients was targeted as it was deemed feasible within the time available and was considered adequate to gain an understanding of the research objectives.

Continuous data will be summarised using mean ± standard deviation (SD), or median (interquartile range) depending on the distribution of the data. Categorical data will be summarised using frequency tables, presented as counts (n) and percentages (%). Univariate analyses will be used to compare the nutrition process of care between hospital settings (ICU, ward, rehabilitation) and will be performed using the T test or the Mann-Whitney U test as appropriate for continuous data, and the chi squared test and Fischer’s exact test as appropriate for categorical data. A 2-sided P value will be used to observe statistical significance. A P value of <0.05 will be deemed statistically significant. Data analysis will be conducted using SPSS and/or SAS software with input from a Monash University statistician.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2021
Actual
22/04/2021
Date of last participant enrolment
Anticipated
Actual
4/05/2021
Date of last data collection
Anticipated
Actual
3/11/2021
Sample size
Target
50
Accrual to date
Final
50
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18140 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 32135 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 307567 0
University
Name [1] 307567 0
Monash University
Country [1] 307567 0
Australia
Primary sponsor type
Individual
Name
Dr Emma Ridley
Address
Australian and New Zealand Intensive Care Research Centre,
Public Health and Preventive Medicine
Monash University
Level 3, 553 St Kilda Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 308253 0
None
Name [1] 308253 0
Address [1] 308253 0
Country [1] 308253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307445 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 307445 0
Ethics committee country [1] 307445 0
Australia
Date submitted for ethics approval [1] 307445 0
22/10/2020
Approval date [1] 307445 0
28/10/2020
Ethics approval number [1] 307445 0
696/20
Ethics committee name [2] 307446 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 307446 0
Ethics committee country [2] 307446 0
Australia
Date submitted for ethics approval [2] 307446 0
18/11/2020
Approval date [2] 307446 0
19/11/2020
Ethics approval number [2] 307446 0
27152

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

Contacts
Principal investigator
Name 107266 0
Dr Emma Ridley
Address 107266 0
Australian and New Zealand Intensive Care Research Centre,
Public Health and Preventive Medicine
Monash University
Level 3, 553 St Kilda Rd
Melbourne VIC 3004
Country 107266 0
Australia
Phone 107266 0
+61 3 9905 6643
Fax 107266 0
Email 107266 0
[email protected]
Contact person for public queries
Name 107267 0
Emma Ridley
Address 107267 0
Australian and New Zealand Intensive Care Research Centre,
Public Health and Preventive Medicine
Monash University
Level 3, 553 St Kilda Rd
Melbourne VIC 3004
Country 107267 0
Australia
Phone 107267 0
+61 3 9905 6643
Fax 107267 0
Email 107267 0
[email protected]
Contact person for scientific queries
Name 107268 0
Emma Ridley
Address 107268 0
Australian and New Zealand Intensive Care Research Centre,
Public Health and Preventive Medicine
Monash University
Level 3, 553 St Kilda Rd
Melbourne VIC 3004
Country 107268 0
Australia
Phone 107268 0
+61 3 9905 6643
Fax 107268 0
Email 107268 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.