- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03226912
The PREDICT Study- a Registry in Critically Ill Patients to Determine Predictors of Disability Free Survival (PREDICT)
Study Overview
Status
Detailed Description
Critical illness affects more than 100,000 patients per year in Australia and more than 25,000 per year in Victoria. Although, hospital mortality in Australia and New Zealand has decreased over the past decade in all major admission categories, and 90% of these patients now survive to return to live in the community, just 28% of previously working ICU survivors are currently expected to return to work after discharge. Most ICU survivors suffer from post-ICU accelerated neurocognitive decline, prolonged neuromuscular weakness, post-traumatic stress disorder, depression, and/or anxiety. The recovery process and long-term outcomes for critically ill patients may be poor, and they can be improved by appropriate interventions, continual support and tracking of patients post-ICU as they recover, as opposed to being discharged to a single general practitioner who may not have the resources to provide adequate rehabilitation. Although this method has been previously seen as cost-effective, this approach actually carries huge costs for the community of the individuals as they often cannot return to work and have ultimately lost independence. By assessing risk factors and measuring long-term outcomes of patient's post-ICU, the severity of the community burden could be decreased with the application of suitable interventions.
The PREDICT study follows on from the successful completion of the ICU-Recovery Project (HREC Reference Alfred Health 180/14) which found that disability was prevalent in ICU and was associated with sepsis and pre-existing mental health problems. The PREDICT study will measure disability-free survival, psychological function, cognitive function and quality of life with health economic outcomes in critically ill patients 3 and 6 months after ICU admission. The study will confirm the predictors of disability-free survival.
These patients add to the community burden and also influence community and rehabilitation costs. Our aim is to improve long-term patient outcomes through: improving sedation practices, delirium prevention, neurocognitive stimulation, early mobilisation, post-ICU follow-up, and functional and psychological rehabilitation. This study is required for the evaluation of hospital and post-ICU rehabilitation practice as there is insufficient evidence to alter current clinical practice.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Victoria
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Melbourne, Victoria, Australia, 3004
- Australian New Zealand Intensive Care Reseearch Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- ICU patients who have been mechanically ventilated for over 24 hours
- Patients 18 years or older
Exclusion Criteria:
- A Proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition (e.g. TBI, SAH, stroke or hypoxic brain injury after cardiac arrest)
- Second or subsequent admission to ICU during a single hospital admission
- Participants who do not speak English
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of a risk-prediction model for disability-free survival in high risk patients (after > 24 hours of mechanical ventilation)
Time Frame: 3-6 months post ICU admission
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Development of a risk-prediction model for disability-free survival in high risk patients (after > 24 hours of mechanical ventilation)
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3-6 months post ICU admission
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health related quality of life (HRQOL)
Time Frame: 3-6 months post ICU admission
|
Health related quality of life (HRQOL) measured with EQ5D before ICU
|
3-6 months post ICU admission
|
Pre ICU health status
Time Frame: 3 months post ICU admission
|
pre ICU health status measured by retrospective EQ5D
|
3 months post ICU admission
|
Global function
Time Frame: 3-6 months post ICU admission
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Global function measured with the WHODAS
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3-6 months post ICU admission
|
Physical activity at 6 months
Time Frame: 6 months post ICU admission
|
Physical activity at 6 months measured with the IADL
|
6 months post ICU admission
|
Cognitive function at 6 months
Time Frame: 6 months post ICU admission
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Cognetive function measured using the MOCA blind
|
6 months post ICU admission
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Anxiety and depression at 6 months will be assessed
Time Frame: 6 months post ICU admission
|
Anxiety and depression at 6 months will be assessed with the Hospital Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES-R)
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6 months post ICU admission
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Return to work at 3 and 6 months
Time Frame: 3-6 months post ICU admission
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Return to work at 3 and 6 months will be measured using extra questions
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3-6 months post ICU admission
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Pre ICU disability and work status
Time Frame: 3 months post ICU admission
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Pre ICU disability and work status measured using the WHODAS
|
3 months post ICU admission
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Hodgson CL, Higgins AM, Bailey M, Barrett J, Bellomo R, Cooper DJ, Gabbe BJ, Iwashyna T, Linke N, Myles PS, Paton M, Philpot S, Shulman M, Young M, Serpa Neto A; PREDICT Study Investigators. Comparison of 6-month outcomes of sepsis versus non-sepsis critically ill patients receiving mechanical ventilation. Crit Care. 2022 Jun 13;26(1):174. doi: 10.1186/s13054-022-04041-w.
- Higgins AM, Neto AS, Bailey M, Barrett J, Bellomo R, Cooper DJ, Gabbe BJ, Linke N, Myles PS, Paton M, Philpot S, Shulman M, Young M, Hodgson CL; PREDICT Study Investigators. Predictors of death and new disability after critical illness: a multicentre prospective cohort study. Intensive Care Med. 2021 Jul;47(7):772-781. doi: 10.1007/s00134-021-06438-7. Epub 2021 Jun 5.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANZIC-RC/CH002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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