The TEAM Long-Term Cohort Study (A Sub-study of TEAM(III))
NCT ID: NCT05298982
Last Updated: 2022-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
250 participants
OBSERVATIONAL
2020-02-11
2026-11-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Intervention arm: TEAM protocol
Based on TEAM (III) protocol patients will be assessed daily by an ICU physiotherapist using the ICU Mobility Scale (IMS) to determine the dosage and type of active exercises the patient will receive, using the early activity and mobilisation protocol. This protocol is hierarchical, with the objective of each intervention session beginning with the highest level of activity possible for the longest time possible, which then steps down to lower levels of activity if the patient fatigues. The intervention will be administered on all days in which the patient is admitted to ICU during the index hospitalisation, censored at 28days after.
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
Standard of Care arm: TEAM protocol
Based on TEAM (III) protocol the control group will receive standard care from physiotherapy staff not involved in delivering the intervention. We have previously established that standard care in Australia for a patient receiving prolonged IMV (control group intervention) frequently involves no active exercise out of bed.
No interventions assigned to this group
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
18 Years
ALL
No
Sponsors
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Medical Research Institute of New Zealand
OTHER
National Health and Medical Research Council, Australia
OTHER
ANZICS Clinical Trials Group
NETWORK
Australian and New Zealand Intensive Care Research Centre
OTHER
Responsible Party
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Principal Investigators
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Prof Carol Hodgson
Role: STUDY_CHAIR
ANZIC-RC
Locations
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Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
John Hunter Hospital
Sydney, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Wollongong Hospital
Wollongong, New South Wales, Australia
Sunshine Coast University Hospital
Birtinya, Queensland, Australia
Mater Health
Brisbane, Queensland, Australia
Mater Private Hospital
Brisbane, Queensland, Australia
Caboolture Hospital
Caboolture, Queensland, Australia
Redcliffe Hospital
Redcliffe, Queensland, Australia
Toowoomba Hospital
Toowoomba, Queensland, Australia
Launceston General Hospital
Launceston, Tasmania, Australia
Geelong Hospital - Barwon Health
Geelong, Victoria, Australia
Cabrini Hospital
Malvern, Victoria, Australia
Royal Melbourne Hospital
Parkville, Victoria, Australia
Alfred Hospital
Prahran, Victoria, Australia
Sunshine Hospital
St Albans, Victoria, Australia
Countries
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References
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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.
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.
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.
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.
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.
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.
Related Links
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TEAM study website
Other Identifiers
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U1111-1195-3567-A9
Identifier Type: -
Identifier Source: org_study_id
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