Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000942550
Ethics application status
Approved
Date submitted
17/08/2015
Date registered
8/09/2015
Date last updated
6/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Rapid and accurate categorization of critically ill patients to measure recovery after hospital admission.
Scientific title
Rapid and accurate categorization of critically ill patients to identify outcomes of interest for longitudinal studies: a feasibility study
Secondary ID [1] 287291 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
RACE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critically ill patients who are mechanically ventilated and require enteral nutrition 295931 0
Condition category
Condition code
Public Health 296191 296191 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients will be categorized at baseline by the intensive care unit (ICU) research coordinator into one of eight unique and predefined social categories for the purpose of follow up at 6months for a large randomized controlled trial.
The categories are:
1. Less than 65 years of age in paid employment;
2. Less than 65 years of age and studying;
3. Less than 65 years of age and chronically disabled;
4.Less than 65 years of age and environmental factors impair ability to work (socially disadvantaged).
5. 65 years of age and over - living independently without essential supports;
6. 65 years of age and over living independently with essential supports;
7. 65 years of age and over living in supportive accommodation.
8. Other
The research coordinator will categorize the patient within 96 hours of admission to the intensive care unit (ICU) by reviewing the medical record, asking the clinical nurse or attending medical officer or other hospital personnel such as the social worker. If the family are at the bedside during assessment they may be asked. This assessment is called the "research coordinator" or baseline assessment. This assessment will take approximately 5 minutes to conduct.
To assess if the research coordinator has accurately categorized the patient a study investigator will conducted an interview with the patient when he or she is well enough to answer questions, which should be just before discharge from the ICU. If the patient is not well enough to answer questions about their social status then the patient's family may answer the questions for them. This assessment is called the "gold standard" assessment. The gold standard assessor will not know what category the research coordinator chose at baseline so as not to influence the answers of the interview. The gold standard assessment will take 1 - 5 minutes to complete. There are 1 to 5 questions to ask.
The 8 categories are broad enough so that patients should fall within one of them. If the patient falls into more than one category this information is collected on the data sheet.
This feasibility study is designed specifically to see if the research coordinator can accurately and rapidly categorize patients into the 8 social categories. If they can the study investigators will use this method for a large randomized controlled nutrition trial for patients to complete a specific questionnaire at the day 180 follow up.
Duration of this observations trial is until ICU discharge.
Intervention code [1] 292613 0
Not applicable
Comparator / control treatment
A gold standard assessment of the patient once they are extubated from mechanical ventilation for 24 hours or more and able to answer questions about the eight unique and predefined categories for the purpose of follow up.
Control group
Active

Outcomes
Primary outcome [1] 295861 0
Accurate categorization of patients by the research coordinator when compared to the "gold standard" semi structured interview subsequently conducted.
Timepoint [1] 295861 0
96 hours after meeting the eligibility criteria
Secondary outcome [1] 316746 0
Rapid assessment of the categorization. How long will it take for the research coordinator to categorization the patient.

The time taken to categorize the patient will be recorded on the assessment form; the number of minutes will be recorded.
Timepoint [1] 316746 0
96 hours after eligibility
Secondary outcome [2] 316747 0
Completeness of our coverage. Are we able to categorize all patients at baseline.
Timepoint [2] 316747 0
96 hours of eligibility
Secondary outcome [3] 316748 0
Uniqueness of categorization. How many patients will fit into just one of the 8 social categories and how many will overlap and could be categorized into more than one.
Timepoint [3] 316748 0
96 hours of eligibility

Eligibility
Key inclusion criteria
18 years of age or over.
Intubated and receiving invasive mechanical ventilation.
Commenced or are they about to commence enteral nutrition.
Expected to receive EN at least until the day after tomorrow.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Enteral nutrition or parenteral nutrition received for greater than 12 hours in this ICU admission.
Treating clinician considers the EN goal rate (i.e. 1ml/kg of ideal body weight per hour) to be clinically contraindicated e.g. requirement for fluid restriction.
Requirement for specific nutritional therapy as determined by the treating doctor or dietitian.
Death is deemed imminent or inevitable during this admission and either the treating physician, patient or substitute decision maker is not committed to active treatment.
The patient has an underlying disease that makes survival to 90 days unlikely.
15% or more burns.
Previously enrolled in this study.

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Recruitment goal will be set at an average of thirty patients at each site (n=120) who are eligible and survived to be discharged alive from ICU to another part of the hospital that provides less invasive care.
Our primary outcome is accuracy, defined as the fraction of patients with an exact match between the categorization at baseline and at gold standard. We wish to insure that accuracy is greater than 80%. If we observe at least 83% accuracy in a sample size of 120 completed patients, then we have greater than 80% confidence that our true accuracy is 80% or above (one-sided confidence intervals) with a two-sided p-value of 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/09/2015
Actual
18/09/2015
Date of last participant enrolment
Anticipated
31/12/2015
Actual
26/02/2016
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 4215 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 4216 0
The Queen Elizabeth Hospital - Woodville
Recruitment hospital [3] 4217 0
The Alfred - Prahran
Recruitment postcode(s) [1] 10179 0
5000 - Adelaide
Recruitment postcode(s) [2] 10181 0
5011 - Woodville
Recruitment postcode(s) [3] 10182 0
3181 - Prahran
Recruitment outside Australia
Country [1] 7094 0
New Zealand
State/province [1] 7094 0
Wellington

Funding & Sponsors
Funding source category [1] 291860 0
Self funded/Unfunded
Name [1] 291860 0
Country [1] 291860 0
Primary sponsor type
University
Name
Monash University
Address
Level 6, 99 Commercial Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 290525 0
None
Name [1] 290525 0
Address [1] 290525 0
Country [1] 290525 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293369 0
Royal Adelaide Hospital Ethics Committee
Ethics committee address [1] 293369 0
Ethics committee country [1] 293369 0
Australia
Date submitted for ethics approval [1] 293369 0
23/07/2015
Approval date [1] 293369 0
28/09/2015
Ethics approval number [1] 293369 0
HREC/15/RAH/322
Ethics committee name [2] 293370 0
The Alfred Hospital Ethics Committee
Ethics committee address [2] 293370 0
Ethics committee country [2] 293370 0
Australia
Date submitted for ethics approval [2] 293370 0
13/08/2015
Approval date [2] 293370 0
16/09/2015
Ethics approval number [2] 293370 0
413/15
Ethics committee name [3] 294974 0
Wellington Hospital
Ethics committee address [3] 294974 0
Ethics committee country [3] 294974 0
New Zealand
Date submitted for ethics approval [3] 294974 0
18/09/2015
Approval date [3] 294974 0
02/11/2015
Ethics approval number [3] 294974 0
15/STH/179

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

Contacts
Principal investigator
Name 59594 0
Dr Adam Deane
Address 59594 0
Intensive Care Unit
The Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 59594 0
Australia
Phone 59594 0
+61 8 8222 2818
Fax 59594 0
+61 8 8222 2367
Email 59594 0
[email protected]
Contact person for public queries
Name 59595 0
Lorraine Little
Address 59595 0
Monash University
Level 6, 99 Commercial Road
Melbourne Vic 3004
Country 59595 0
Australia
Phone 59595 0
+61 3 9903 0513
Fax 59595 0
+61 3 9903 0071
Email 59595 0
[email protected]
Contact person for scientific queries
Name 59596 0
Adam Deane
Address 59596 0
Intensive Care Unit
The Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Country 59596 0
Australia
Phone 59596 0
+61 8 8222 2818
Fax 59596 0
+61 8 8222 2367
Email 59596 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

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