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

Depression Clinical Trial

— PREDICT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226912
• Other study ID #: ANZIC-RC/CH002
• Status: Completed
• Start date: July 18, 2017
• Est. completion date: March 31, 2020

Study information

• Verified date: September 2023
• Source: Australian and New Zealand Intensive Care Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 31, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Australia	Australian New Zealand Intensive Care Reseearch Centre	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Australian and New Zealand Intensive Care Research Centre	National Health and Medical Research Council, Australia

Country where clinical trial is conducted

Australia, 

References & Publications (1)

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 pros — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3-6 months post ICU admission
Secondary	Health related quality of life (HRQOL)	Health related quality of life (HRQOL) measured with EQ5D before ICU	3-6 months post ICU admission
Secondary	Pre ICU health status	pre ICU health status measured by retrospective EQ5D	3 months post ICU admission
Secondary	Global function	Global function measured with the WHODAS	3-6 months post ICU admission
Secondary	Physical activity at 6 months	Physical activity at 6 months measured with the IADL	6 months post ICU admission
Secondary	Cognitive function at 6 months	Cognetive function measured using the MOCA blind	6 months post ICU admission
Secondary	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)	6 months post ICU admission
Secondary	Return to work at 3 and 6 months	Return to work at 3 and 6 months will be measured using extra questions	3-6 months post ICU admission
Secondary	Pre ICU disability and work status	Pre ICU disability and work status measured using the WHODAS	3 months post ICU admission