Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000031561
Ethics application status
Approved
Date submitted
11/12/2014
Date registered
19/01/2015
Date last updated
8/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The Fluid Translation of Research into Practice Study - Discrete Choice Experiment (Survey) of Intensive Care clinicians preferences of resuscitation fluid.
Scientific title
Discrete choice experiment to understand what drives intensive care clinicians' choice of fluid type used for fluid resuscitation in intensive care patients
Secondary ID [1] 285817 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Fluid TRIPS DCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 293720 0
Hypovolemia 293721 0
Fluid resuscitation 293722 0
Condition category
Condition code
Public Health 294022 294022 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The aim of this study is to define and understand the fundamental drivers of fluid resuscitation choice for critically ill patients. The study uses a scenario based survey of clinician preferences using the Discrete Choice Experiment (DCE) methodology. The survey will be administered online via a secure database and will take each clinician approximately 20-30 minutes to complete. The study period is anticipated to run for 2-3 months.
Intervention code [1] 290789 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293799 0
The primary objective of this study is to identify key attributes that have the largest influence on the choice of fluid used for resuscitation.

The statistical analysis of the DCE data will involve a mixed multinomial (randoms parameters) logit model (MMNL) using a panel size specification.
Timepoint [1] 293799 0
Within 6 months of completion of the Fluid TRIPS Study
Australian New Zealand Clinical Trials Registry, Number:ACTRN12613001172796
Secondary outcome [1] 311899 0
The secondary objective is to describe a “willingness to spend” threshold (by international region) where clinicians will switch from less expensive preparations to more expensive preparations.

The analysis will enable: 1) estimates of the marginal effect of each attribute, and respondent characteristic on choice of resuscitation fluid; 2) the relative tradeoff (or marginal rate of substitution) between attributes, in particular the calculation of clinician “willingness to spend” thresholds, and 3) predictions to be made of the preference for current resuscitation fluids.
Timepoint [1] 311899 0
Within 6 months of completion of the Fluid TRIPS Study Australian New Zealand Clinical Trials Registry, Number:ACTRN12613001172796

Eligibility
Key inclusion criteria
Intensive Care Clinician at participating hospital
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/03/2015
Actual
14/08/2015
Date of last participant enrolment
Anticipated
Actual
30/12/2015
Date of last data collection
Anticipated
Actual
29/02/2016
Sample size
Target
352
Accrual to date
Final
367
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 6517 0
New Zealand
State/province [1] 6517 0
Country [2] 6518 0
Brazil
State/province [2] 6518 0
Country [3] 6519 0
Belgium
State/province [3] 6519 0
Country [4] 6520 0
Canada
State/province [4] 6520 0
Country [5] 6521 0
Chile
State/province [5] 6521 0
Country [6] 6522 0
France
State/province [6] 6522 0
Country [7] 6523 0
Germany
State/province [7] 6523 0
Country [8] 6524 0
Ireland
State/province [8] 6524 0
Country [9] 6525 0
Italy
State/province [9] 6525 0
Country [10] 6526 0
Japan
State/province [10] 6526 0
Country [11] 6527 0
Monaco
State/province [11] 6527 0
Country [12] 6528 0
Singapore
State/province [12] 6528 0
Country [13] 6529 0
South Africa
State/province [13] 6529 0
Country [14] 6530 0
United Arab Emirates
State/province [14] 6530 0
Country [15] 6531 0
Switzerland
State/province [15] 6531 0
Country [16] 6532 0
United States of America
State/province [16] 6532 0
Country [17] 6534 0
China
State/province [17] 6534 0
Country [18] 6535 0
Denmark
State/province [18] 6535 0
Country [19] 6536 0
Hong Kong
State/province [19] 6536 0
Country [20] 6537 0
Sweden
State/province [20] 6537 0

Funding & Sponsors
Funding source category [1] 290377 0
Other Collaborative groups
Name [1] 290377 0
The George Institute for Global Health
Country [1] 290377 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The George Institute for Global Health
Address
L13, 321 Kent Street
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 289204 0
None
Name [1] 289204 0
Address [1] 289204 0
Country [1] 289204 0
Other collaborator category [1] 278266 0
Charities/Societies/Foundations
Name [1] 278266 0
Intensive Care Foundation
Address [1] 278266 0
Level 2, 10 Ievers Terrace
Carlton South
VIC AUSTRALIA 3053
Country [1] 278266 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292097 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 292097 0
Research Development Office
Suite 210A
RPAH Medical Centre
100 Carillon Avenue
NEWTOWN NSW 2042
Ethics committee country [1] 292097 0
Australia
Date submitted for ethics approval [1] 292097 0
08/01/2015
Approval date [1] 292097 0
08/05/2015
Ethics approval number [1] 292097 0
EC00152

Summary
Brief summary
Hypotheses: The choice of fluid resuscitation preparations selected by clinicians is determined by short term considerations such as time to haemodynamic benefit and fluid volume required rather than by level of evidence, risk of adverse events or cost.
Objectives: The primary objective of this study is to identify the attributes that have the largest influence on the choice of fluid used for resuscitation. The secondary objective is to describe a “willingness to spend” threshold (by international region) where clinicians will switch from less expensive preparations to more expensive preparations.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53390 0
Dr Colman Taylor
Address 53390 0
The George Institute for Global Health
L13,321 Kent Street
Sydney NSW 2000
Country 53390 0
Australia
Phone 53390 0
+61 2 9657 0316
Fax 53390 0
Email 53390 0
ctaylor@georgeinstitute.org.au
Contact person for public queries
Name 53391 0
Dr Colman Taylor
Address 53391 0
The George Institute for Global Health
L13,321 Kent Street
Sydney NSW 2000
Country 53391 0
Australia
Phone 53391 0
+61 2 9657 0316
Fax 53391 0
Email 53391 0
ctaylor@georgeinstitute.org.au
Contact person for scientific queries
Name 53392 0
Dr Colman Taylor
Address 53392 0
The George Institute for Global Health
L13,321 Kent Street
Sydney NSW 2000
Country 53392 0
Australia
Phone 53392 0
+61 2 9657 0316
Fax 53392 0
Email 53392 0
ctaylor@georgeinstitute.org.au

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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