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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03226912
Acronym
PREDICT
Enrollment
500
Registered
2017-07-24
Start date
2017-07-18
Completion date
2020-03-31
Last updated
2023-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

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.

Interventions

None listed

Sponsors

National Health and Medical Research Council, Australia
CollaboratorOTHER
Australian and New Zealand Intensive Care Research Centre
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Development of a risk-prediction model for disability-free survival in high risk patients (after > 24 hours of mechanical ventilation)3-6 months post ICU admissionDevelopment of a risk-prediction model for disability-free survival in high risk patients (after \> 24 hours of mechanical ventilation)

Secondary

MeasureTime frameDescription
Pre ICU health status3 months post ICU admissionpre ICU health status measured by retrospective EQ5D
Global function3-6 months post ICU admissionGlobal function measured with the WHODAS
Physical activity at 6 months6 months post ICU admissionPhysical activity at 6 months measured with the IADL
Health related quality of life (HRQOL)3-6 months post ICU admissionHealth related quality of life (HRQOL) measured with EQ5D before ICU
Anxiety and depression at 6 months will be assessed6 months post ICU admissionAnxiety and depression at 6 months will be assessed with the Hospital Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES-R)
Return to work at 3 and 6 months3-6 months post ICU admissionReturn to work at 3 and 6 months will be measured using extra questions
Pre ICU disability and work status3 months post ICU admissionPre ICU disability and work status measured using the WHODAS
Cognitive function at 6 months6 months post ICU admissionCognetive function measured using the MOCA blind

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026