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.

Overview

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

Interventions

• Behavioral Early activity and Mobilisation Intervention
  The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities

Primary outcome measures

• Level of disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) 2.0 [Time frame: Assessed 2 years after recruitment]

Secondary outcome measures (12)

• Time from randomisation until death [Time frame: From date of randomisation until date of death from all cause, censored at 5 years]
• All-cause mortality [Time frame: From date of randomisation to 1 year]
• All-cause mortality [Time frame: From date of randomisation to 2 years]
• All-cause mortality [Time frame: From date of randomisation to 5 years]
• Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS) [Time frame: Assessed 1 year after recruitment]
• Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS) [Time frame: Assessed 5 years after recruitment]
• Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) [Time frame: Assessed 1 year after recruitment]
• Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) [Time frame: Assessed 2 years after recruitment]
• Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) [Time frame: Assessed 5 years after recruitment]
• Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL) [Time frame: Assessed 1 year after recruitment]
• Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL) [Time frame: Assessed 2 years after recruitment]
• Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL) [Time frame: Assessed 5 years after recruitment]

Eligibility criteria

Inclusion criteria

• Enrolled in the TEAM Phase III RCT Protocol.

Exclusion criteria

• There are no exclusion criteria.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Australia · 16 centers

• Royal Prince Alfred Hospital — Camperdown
• John Hunter Hospital — Sydney
• Royal North Shore Hospital — Sydney
• Wollongong Hospital — Wollongong
• Sunshine Coast University Hospital — Birtinya
• Mater Health — Brisbane
• Mater Private Hospital — Brisbane
• Caboolture Hospital — Caboolture
• … and 8 more centers

Publications

• 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. PMID 24638143
• 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. PMID 21470008
• 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. PMID 25715872
• 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. PMID 20679565
• 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. PMID 22875378
• 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. PMID 21675057

Identifiers

NCT: NCT05298982 · U1111-1195-3567-A9

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗