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

• ClinicalTrials.gov Identifier: NCT03226912
• Recruitment Status: Active, not recruiting
• First Posted: July 24, 2017
• Last Update Posted: September 3, 2019
• Sponsor: Australian and New Zealand Intensive Care Research Centre
• Collaborator: National Health and Medical Research Council, Australia
• Information provided by (Responsible Party): Australian and New Zealand Intensive Care Research Centre

Study Description

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.

Study Design

• 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

Groups and Cohorts

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

• 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
• Last Update Posted: September 3, 2019
• Last Verified: August 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Critical Illness; Disease Attributes; Pathologic Processes