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The PREDICT Study- a Registry in Critically Ill Patients to Determine Predictors of Disability Free Survival (PREDICT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226912
Recruitment Status : Active, not recruiting
First Posted : July 24, 2017
Last Update Posted : September 3, 2019
Sponsor:
Collaborator:
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Australian and New Zealand Intensive Care Research Centre

Brief 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. 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.

Condition or disease
Critical Illness Mechanical Ventilation Complication Disabilities Multiple Quality of Life Physical Disability Anxiety Depression Cognitive Change

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The PREDICT Study- a Registry in Critically Ill Patients to Determine Predictors of Disability Free Survival
Actual Study Start Date : July 18, 2017
Actual Primary Completion Date : December 30, 2018
Estimated Study Completion Date : November 28, 2019



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. Pre ICU health status [ Time Frame: 3 months post ICU admission ]
    pre ICU health status measured by retrospective EQ5D

  3. Global function [ Time Frame: 3-6 months post ICU admission ]
    Global function measured with the WHODAS

  4. Physical activity at 6 months [ Time Frame: 6 months post ICU admission ]
    Physical activity at 6 months measured with the IADL

  5. Cognitive function at 6 months [ Time Frame: 6 months post ICU admission ]
    Cognetive function measured using the MOCA blind

  6. 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)

  7. Return to work at 3 and 6 months [ Time Frame: 3-6 months post ICU admission ]
    Return to work at 3 and 6 months will be measured using extra questions

  8. Pre ICU disability and work status [ Time Frame: 3 months post ICU admission ]
    Pre ICU disability and work status measured using the WHODAS



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
500 critically ill patients who were mechanically ventilated > 24 hours in an intensive care unit who have survived to hospital discharge.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03226912


Locations
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Australia, Victoria
Australian New Zealand Intensive Care Reseearch Centre
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Australian and New Zealand Intensive Care Research Centre
National Health and Medical Research Council, Australia

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Responsible Party: Australian and New Zealand Intensive Care Research Centre
ClinicalTrials.gov Identifier: NCT03226912    
Other Study ID Numbers: ANZIC-RC/CH002
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Critical Illness
Disease Attributes
Pathologic Processes