Clinical trial NCT05298982: The TEAM Long-Term Cohort Study (A Sub-study of TEAM(III))
Official title: Long-term Evaluation of Disability and Quality of Life at 1,2 and 5 Years in Invasively Mechanically Ventilated Patients Who Received Early Activity and Mobilisation Compared to Standard Care.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Critically Ill
Mechanical Ventilation
Long Term Outcome
Keywords: Early activity and mobilization
rehabilitation
intensive care
health status
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: Medical Research Institute of New Zealand
name: National Health and Medical Research Council, Australia
name: ANZICS Clinical Trials Group
First posted: 2022-03-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 380 critically ill adult Australian patients, who met all of the inclusion criteria and none of the exclusion criteria, as defined in the TEAM Phase III RCT and consent to follow-up.

Brief summary: This study is a prospective cohort study to evaluate the long-term effects of early activity and mobilisation compared to standard care on disability, function and health status for patients at 1, 2 and 5 years after recruitment of patients randomised into the TEAM Phase III RCT (ClinicalTrials.gov NCT03133377). The primary outcome of the study will be the level of disability as measured by the World Health Organisation's Disability Schedule 2.0, 12 level (WHODAS) at 2 years after recruitment.

Detailed description: Incomplete recovery following critical illness is a major public health problem in Australia.

Each year around 150,000 Australians are admitted to intensive care (ICU). These critically ill patients require substantial resources and invasive, expensive interventions. Approximately 10% die and many of the remaining patients who survive have delayed and compromised functional recovery. As many as 25% of the ICU survivors who were living at home prior to ICU are unable to return home due to impaired physical function. Globally, the quality of survival following an ICU admission has been identified as one of the largest health challenges for these patients. This study will address the quality of survival and long-term functional recovery for patients who require life support in ICU. These patients account for 62% of the total bed-days in Australian ICUs, with direct care costs of $2 billion per year. The long-term outcomes for these patients are very poor. In my Australian cohort study, 50% of patients who survived hospital had disability

Eligibility criteria: Inclusion Criteria:

* Enrolled in the TEAM Phase III RCT Protocol.

Exclusion Criteria:

* There are no exclusion criteria.

Primary outcomes:
measure: Level of disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) 2.0
timeFrame: Assessed 2 years after recruitment
Secondary outcomes:
measure: Time from randomisation until death
timeFrame: From date of randomisation until date of death from all cause, censored at 5 years
measure: All-cause mortality
timeFrame: From date of randomisation to 1 year
measure: All-cause mortality
timeFrame: From date of randomisation to 2 years
measure: All-cause mortality
timeFrame: From date of randomisation to 5 years
measure: Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS)
timeFrame: Assessed 1 year after recruitment
measure: Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS)
timeFrame: Assessed 5 years after recruitment
measure: Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
timeFrame: Assessed 1 year after recruitment
measure: Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
timeFrame: Assessed 2 years after recruitment
measure: Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L)
timeFrame: Assessed 5 years after recruitment
measure: Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)
timeFrame: Assessed 1 year after recruitment
measure: Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)
timeFrame: Assessed 2 years after recruitment
measure: Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL)
timeFrame: Assessed 5 years after recruitment
measure: Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)
timeFrame: Assessed 1 year after recruitment
measure: Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)
timeFrame: Assessed 2 years after recruitment
measure: Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind)
timeFrame: Assessed 5 years after recruitment
measure: Psychological function measured using Hospital Anxiety and Depression scale
timeFrame: Assessed 1 year after recruitment
measure: Psychological function measured using Hospital Anxiety and Depression scale
timeFrame: Assessed 2 years after recruitment
measure: Psychological function measured using Hospital Anxiety and Depression scale
timeFrame: Assessed 5 years after recruitment
measure: Psychological function measured using Impact of Event Scale - Revised (IES-R)
timeFrame: Assessed 1 year after recruitment
measure: Psychological function measured using Impact of Event Scale - Revised (IES-R)
timeFrame: Assessed 2 years after recruitment
measure: Psychological function measured using Impact of Event Scale - Revised (IES-R)
timeFrame: Assessed 5 years after recruitment
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Sydney
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
state: Queensland
city: Brisbane
country: Australia
facility: Mater Health
state: Queensland
city: Brisbane
country: Australia
facility: Mater Private Hospital
state: Queensland
city: Caboolture
country: Australia
facility: Caboolture Hospital
state: Queensland
city: Redcliffe
country: Australia
facility: Redcliffe Hospital
state: Queensland
city: Toowoomba
country: Australia
facility: Toowoomba Hospital
state: Queensland
city: Launceston
country: Australia
facility: Launceston General Hospital
state: Tasmania
city: Geelong
country: Australia
facility: Geelong Hospital - Barwon Health
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital
state: Victoria
city: Prahran
country: Australia
facility: Alfred Hospital
state: Victoria
city: St Albans
country: Australia
facility: Sunshine Hospital
state: Victoria
Study officials:
affiliation: ANZIC-RC
name: Prof Carol Hodgson
role: STUDY_CHAIR
References:
citation: Kaukonen KM, Bailey M, Suzuki S, Pilcher D, Bellomo R. Mortality related to severe sepsis and septic shock among critically ill patients in Australia and New Zealand, 2000-2012. JAMA. 2014 Apr 2;311(13):1308-16. doi: 10.1001/jama.2014.2637.
citation: Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.
citation: TEAM Study Investigators; Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4.
citation: Iwashyna TJ. Survivorship will be the defining challenge of critical care in the 21st century. Ann Intern Med. 2010 Aug 3;153(3):204-5. doi: 10.7326/0003-4819-153-3-201008030-00013. No abstract available.
citation: Iwashyna TJ, Netzer G. The burdens of survivorship: an approach to thinking about long-term outcomes after critical illness. Semin Respir Crit Care Med. 2012 Aug;33(4):327-38. doi: 10.1055/s-0032-1321982. Epub 2012 Aug 8.
citation: Higgins AM, Pettila V, Harris AH, Bailey M, Lipman J, Seppelt IM, Webb SA. The critical care costs of the influenza A/H1N1 2009 pandemic in Australia and New Zealand. Anaesth Intensive Care. 2011 May;39(3):384-91. doi: 10.1177/0310057X1103900308.