Critical IllnessPREDICTNCT03226912
The PREDICT Study- a Registry in Critically Ill Patients to Determine Predictors of Disability Free Survival
An observational study of Critical Illness and Mechanical Ventilation Complication, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.
Trial summary
As mortality from critical illness has reduced, the importance of measuring disabilities (cognitive, functional and psychological) in surviving critically ill patients has become more important. Currently, the causes, long-term effects and frequency of disabilities in patients surviving ICU in Australia are unknown. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Mechanical Ventilation Complication, Disabilities Multiple
- How many people
- 500 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Jul 2017to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 500 critically ill patients who were mechanically ventilated > 24 hours in an intensive care unit who have survived to hospital discharge.
Who may be able to join
- ICU patients who have been mechanically ventilated for over 24 hours
- Patients 18 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Australia1 site
Australian New Zealand Intensive Care Reseearch Centre
Melbourne, Victoria, 3004
About this study
As mortality from critical illness has reduced, the importance of measuring disabilities (cognitive, functional and psychological) in surviving critically ill patients has become more important. Currently, the causes, long-term effects and frequency of disabilities in patients surviving ICU in Australia are unknown. In the US and UK, studies have been undertaken to assess the effects of specific long-term outcomes, such as functional disability and depression, which found long-term disabilities were much higher than baselines (pre-illness function) and ongoing at five years after ICU discharge. In order to improve quality of life of ICU survivors and ensure that medical specialists apply appropriate interventions to reduce the cost of these surviving patients on the community, the PREDICT management committee proposes the introduction of a patient-reported outcomes registry.
Read the 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.
- Conditions
- Critical Illness, Mechanical Ventilation Complication, Disabilities Multiple, Quality of Life, Physical Disability, Anxiety
- Medical subject headings
- Critical Illness, Anxiety Disorders, Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of a risk-prediction model for disability-free survival in high risk patients (after > 24 hours of mechanical ventilation)
Development of a risk-prediction model for disability-free survival in high risk patients (after > 24 hours of mechanical ventilation)
Measured: 3-6 months post ICU admission
Secondary outcomes (8)
Health related quality of life (HRQOL)
Health related quality of life (HRQOL) measured with EQ5D before ICU
Measured: 3-6 months post ICU admission
Pre ICU health status
pre ICU health status measured by retrospective EQ5D
Measured: 3 months post ICU admission
Global function
Global function measured with the WHODAS
Measured: 3-6 months post ICU admission
Physical activity at 6 months
Physical activity at 6 months measured with the IADL
Measured: 6 months post ICU admission
Cognitive function at 6 months
Cognetive function measured using the MOCA blind
Measured: 6 months post ICU admission
Anxiety and depression at 6 months will be assessed
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)
Measured: 6 months post ICU admission
Return to work at 3 and 6 months
Return to work at 3 and 6 months will be measured using extra questions
Measured: 3-6 months post ICU admission
Pre ICU disability and work status
Pre ICU disability and work status measured using the WHODAS
Measured: 3 months post ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start18 Jul 2017
- Primary completion31 Oct 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226912
- Sponsor's protocol ID
- ANZIC-RC/CH002
- Acronym
- PREDICT
- Status last verified
- Sep 2023
- First submitted
- 17 Jul 2017
- Last updated
- 15 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34089063Hodgson 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.
PubMed 35698201
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PREDICT Study- a Registry in Critically Ill Patients to Determine Predictors of Disability Free Survival
- ClinicalTrials.gov ID
- NCT03226912
- Acronym / sponsor ID
- PREDICT / ANZIC-RC/CH002
- Conditions
- Critical Illness, Mechanical Ventilation Complication, Disabilities Multiple, Quality of Life, Physical Disability, Anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- National Health and Medical Research Council, Australia
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
As mortality from critical illness has reduced, the importance of measuring disabilities (cognitive, functional and psychological) in surviving critically ill patients has become more important. Currently, the causes, long-term effects and frequency of disabilities in patients surviving ICU in Australia are unknown. In the US and UK, studies have been undertaken to assess the effects of specific long-term outcomes, such as functional disability and depression, which found long-term disabilities were much higher than baselines (pre-illness function) and ongoing at five years after ICU discharge. In order to improve quality of life of ICU survivors and ensure that medical specialists apply appropriate interventions to reduce the cost of these surviving patients on the community, the PREDICT management committee proposes the introduction of a patient-reported outcomes registry.
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 design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 500 critically ill patients who were mechanically ventilated > 24 hours in an intensive care unit who have survived to hospital discharge.
Key inclusion criteria (2 listed)
- ICU patients who have been mechanically ventilated for over 24 hours
- Patients 18 years or older
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Development of a risk-prediction model for disability-free survival in high risk patients (after > 24 hours of mechanical ventilation)
8 secondary outcomes
Health related quality of life (HRQOL)
Time frame: 3-6 months post ICU admission
Pre ICU health status
Time frame: 3 months post ICU admission
Global function
Time frame: 3-6 months post ICU admission
Physical activity at 6 months
Time frame: 6 months post ICU admission
Cognitive function at 6 months
Time frame: 6 months post ICU admission
Anxiety and depression at 6 months will be assessed
Time frame: 6 months post ICU admission
Return to work at 3 and 6 months
Time frame: 3-6 months post ICU admission
Pre ICU disability and work status
Time frame: 3 months post ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Results publication: PubMed 34089063Higgins 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.
- Derived from this study: PubMed 35698201Hodgson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Mechanical Ventilation Complication, run by Australian and New Zealand Intensive Care Research Centre at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03226912, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2023.