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

Completed

• Conditions: Mechanical Ventilation Complication; Disabilities Multiple; Quality of Life; Critical Illness; Depression; Anxiety; Physical Disability; Cognitive Change

• Registration Number: NCT03226912
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-07-17
• Study Start: 2017-07-18
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-24
• Primary Completion: 2019-10-31
• Study Completion: 2020-03-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 admission	Development of a risk-prediction model for disability-free survival in high risk patients (after \> 24 hours of mechanical ventilation)

Secondary Outcome Measures

Name	Time	Method
Pre ICU disability and work status	3 months post ICU admission	Pre ICU disability and work status measured using the WHODAS
Return to work at 3 and 6 months	3-6 months post ICU admission	Return to work at 3 and 6 months will be measured using extra questions
Cognitive function at 6 months	6 months post ICU admission	Cognetive function measured using the MOCA blind
Pre ICU health status	3 months post ICU admission	pre ICU health status measured by retrospective EQ5D
Health related quality of life (HRQOL)	3-6 months post ICU admission	Health related quality of life (HRQOL) measured with EQ5D before ICU
Global function	3-6 months post ICU admission	Global function measured with the WHODAS
Physical activity at 6 months	6 months post ICU admission	Physical activity at 6 months measured with the IADL
Anxiety and depression at 6 months will be assessed	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)

Trial Locations

Locations (1)

Australian New Zealand Intensive Care Reseearch Centre; 🇦🇺 Melbourne, Victoria, Australia