Trial from ANZCTR


Trial ID ACTRN12608000407392
Trial Status: Registered
Date Submitted: 31/05/2007
Date Registered: 19/08/2008
Retrospectively registered

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Public title Australian and New Zealand Cluster Randomised trial of Evidence-based Guidelines for Nutrition Support in Critical Illness
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Cluster randomised trial evaluating the impact on mortality of evidence based guidelines for nutritional support in critical illness
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Critical illness, fasting, starvation, malnourishment 2163 0
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Condition category: Condition code:
Diet and nutrition Other diet and nutrition disorders
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2258 2258 0 0

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Descriptions 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).
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Intervention Code:
Prevention 1796 0
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Intervention Code:
Other interventions 3279 0
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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.
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Control group Active
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Primary Outcome: Mortality 3120 0
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Timepoint: Hospital Discharge 3120 0
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Primary Outcome: Mortality 4626 0
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Timepoint: Hospital Discharge 4626 0
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Primary Outcome: Mortality 4627 0
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Timepoint: Hospital Discharge 4627 0
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Secondary Outcome: organ dysfunction, resource consumption, severity of illness 5237 0
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Timepoint: during ICU stay 5237 0
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Secondary Outcome: Severity of illness / measures of morbidity 7821 0
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Timepoint: Durint ICU stay 7821 0
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Secondary Outcome: morbidity 7822 0
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Timepoint: during ICU stay 7822 0
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Key inclusion criteria Adult patients expected to require ICU care for longer than 2 days.
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Minimum age 18 Years
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Maximum age Not stated
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Gender Both males and females
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Healthy volunteers? No
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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.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Open (masking not used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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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.
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Type of endpoint(s) Efficacy
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Statistical Methods/Analysis
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Phase Phase 3 / Phase 4
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Anticipated date of first participant enrolment 1/04/2003
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 1500
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Recruitment status Completed
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Recruitment in Australia

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Recruitment outside Australia

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Funding Source: Charities/Societies/Foundations 3744 0
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Name: ANZIC Foundation 3744 0
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Address: Level 2, 10 Ievers Terrace - CARLTON VIC 3053 3744 0
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Country: Australia 3744 0
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Primary Sponsor Individual
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Name: Dr Gordon Doig
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Address: Northern Clinical School
University of Sydney
Sydney 2006
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Country: Australia
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Secondary Sponsor: None 3358 0
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Name: 3358 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: University of Sydney 5798 0
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Address: University of Sydney
Human Research Ethics Committee,
Sydney, NSW 2006
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Country: Australia 5798 0
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Approval Date: 26/06/2003 5798 0
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Submitted Date: 5798 0
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HREC: 0209-150M 5798 0
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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.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Gordon Doig
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Address: Intensive Care Unit (ICU) Royal North Shore Hospital (RNSH) Pacific Highway St Leondards NSW 2065
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Country: Australia
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Tel: +61 2 99268656
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Fax: +61 2 94398418
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Email: gdoig@med.usyd.edu.au
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Contact person for scientific queries
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Name: Dr Gordon Doig
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Address: Intensive Care Unit (ICU) Royal North Shore Hospital (RNSH) Pacific Highway St Leondards NSW 2065
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Country: Australia
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Tel: +61 2 99268656
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Email: gdoig@med.usyd.edu.au
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Contact person responsible for updating information
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Name: Dr Gordon Doig
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Address: Intensive Care Unit (ICU) Royal North Shore Hospital (RNSH) Pacific Highway
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Country: Australia
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Tel: 612 9926 8656
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Fax: 612 9439 8418
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Email: gdoig@med.usyd.edu.au
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Addition Cancer fields
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