Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000407392
Ethics application status
Approved
Date submitted
31/05/2007
Date registered
19/08/2008
Date last updated
19/08/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian and New Zealand Cluster Randomised trial of Evidence-based Guidelines for Nutrition Support in Critical Illness
Scientific title
Cluster randomised trial evaluating the impact on mortality of evidence based guidelines for nutritional support in critical illness
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical illness, fasting, starvation, malnourishment 2163 0
Condition category
Condition code
Diet and Nutrition 2258 2258 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study intervention involves the implementation of National-level guidelines for the provision of nutritional support in critical illness. 27 hospitals participated in this trial: 14 hospitals were randomised to the intervention group (guidelines implementation) and 13 were randomised to the control (standard care) group. The 14 intervention group hospitals received education on the content of the feeding guidelines and the 13 control hospitals received no education. Education was provided via a formal practice change strategy composed of Educational Outreach (one session, 45-60mins), Academic Detailing (as much as required), Posters, Active Reminders, Audit and Feedback and traditional in-servicing (as many sessions as required, 30-60mins per session).
Intervention code [1] 1796 0
Prevention
Intervention code [2] 3279 0
Other interventions
Comparator / control treatment
In the Control / Standard Care arm of the trial, hospitals received no educational intervention and continued to practice nutritional support as determined by current local standards.
Control group
Active

Outcomes
Primary outcome [1] 3120 0
Mortality
Timepoint [1] 3120 0
Hospital Discharge
Primary outcome [2] 4626 0
Mortality
Timepoint [2] 4626 0
Hospital Discharge
Primary outcome [3] 4627 0
Mortality
Timepoint [3] 4627 0
Hospital Discharge
Secondary outcome [1] 5237 0
organ dysfunction, resource consumption, severity of illness
Timepoint [1] 5237 0
during ICU stay
Secondary outcome [2] 7821 0
Severity of illness / measures of morbidity
Timepoint [2] 7821 0
Durint ICU stay
Secondary outcome [3] 7822 0
morbidity
Timepoint [3] 7822 0
during ICU stay

Eligibility
Key inclusion criteria
Adult patients expected to require ICU care for longer than 2 days.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Already tolerating an adequate oral diet;
2. Scheduled to return to oral intake within 24 hours;
3. Admitted to ICU for palliative care;
4. Moribund and not expected to survive 6 hours;
5. Brain dead or suspected to be brain dead;
6. Admitted directly to the study ICU from any other ICU.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This was a cluster randomised trial. Hospitals (not patients) were randomised to implement the guideline or remain as controls. After agreeing to participate in the study, hospitals were randomised using a centralised computer program developed in SAS.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation, stratifed by key hospital characteristics (bed number), generated using SAS.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Cluster randomised. Hospitals (not patients) were randomised to receive and implement and evidence-based guideline or to remain as control (no guideline) hospitals.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3744 0
Charities/Societies/Foundations
Name [1] 3744 0
ANZIC Foundation
Country [1] 3744 0
Australia
Primary sponsor type
Individual
Name
Dr Gordon Doig
Address
Northern Clinical School
University of Sydney
Sydney 2006
Country
Australia
Secondary sponsor category [1] 3358 0
None
Name [1] 3358 0
Address [1] 3358 0
Country [1] 3358 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5798 0
University of Sydney
Ethics committee address [1] 5798 0
University of Sydney
Human Research Ethics Committee,
Sydney, NSW 2006
Ethics committee country [1] 5798 0
Australia
Date submitted for ethics approval [1] 5798 0
Approval date [1] 5798 0
26/06/2003
Ethics approval number [1] 5798 0
0209-150M

Summary
Brief summary
Nutritional support is accepted as a standard of care for critically ill patients although there is little agreement as to how it is best provided. Use of evidence-based guidelines has been shown to improve the effectiveness of care. The purpose of this project is to develop, promote and evaluate evidence-based clinical practice guidelines for nutritional support in the ICU in twenty-six hospitals throughout Australia and New Zealand. One half of the hospitals will be randomised to receive educational sessions based on the content of the guidelines using previously proven and accepted educational strategies. A cluster randomised trial will then evaluate the impact of these educational sessions on acceptance of the guideline and on patient outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27899 0
Address 27899 0
Country 27899 0
Phone 27899 0
Fax 27899 0
Email 27899 0
Contact person for public queries
Name 10985 0
Dr Gordon Doig
Address 10985 0
Intensive Care Unit (ICU)
Royal North Shore Hospital (RNSH)
Pacific Highway
St Leondards NSW 2065
Country 10985 0
Australia
Phone 10985 0
+61 2 99268656
Fax 10985 0
+61 2 94398418
Email 10985 0
[email protected]
Contact person for scientific queries
Name 1913 0
Dr Gordon Doig
Address 1913 0
Intensive Care Unit (ICU)
Royal North Shore Hospital (RNSH)
Pacific Highway
St Leondards NSW 2065
Country 1913 0
Australia
Phone 1913 0
+61 2 99268656
Fax 1913 0
+61 2 94398418
Email 1913 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.