The TEAM Long-Term Cohort Study (A Sub-study of TEAM(III))
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
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
|
| 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. |
Outcome Measures
Primary Outcome Measures
- Level of disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) 2.0 [Assessed 2 years after recruitment]
level of disability as measured by the World Health Organisation's Disability Schedule 2.0, 2 level (WHODAS) at 2 years after recruitment.
Secondary Outcome Measures
- Time from randomisation until death [From date of randomisation until date of death from all cause, censored at 5 years]
- All-cause mortality [From date of randomisation to 1 year]
- All-cause mortality [From date of randomisation to 2 years]
- All-cause mortality [From date of randomisation to 5 years]
- Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS) [Assessed 1 year after recruitment]
- Generic function and disability measured using World Health Organisation's Disability Assessment Schedule (WHODAS) [Assessed 5 years after recruitment]
- Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) [Assessed 1 year after recruitment]
- Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) [Assessed 2 years after recruitment]
- Quality of life and health status measured using the European Quality of Life 5 Dimensions 5 Level (EQ5D-5L) [Assessed 5 years after recruitment]
- Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL) [Assessed 1 year after recruitment]
- Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL) [Assessed 2 years after recruitment]
- Independent activities of daily living measured with The Lawton Instrumental Activities of Daily Living Scale (IADL) [Assessed 5 years after recruitment]
- Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind) [Assessed 1 year after recruitment]
- Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind) [Assessed 2 years after recruitment]
- Cognitive function measured using Montreal Cognitive Assessment (MOCA-Blind) [Assessed 5 years after recruitment]
- Psychological function measured using Hospital Anxiety and Depression scale [Assessed 1 year after recruitment]
- Psychological function measured using Hospital Anxiety and Depression scale [Assessed 2 years after recruitment]
- Psychological function measured using Hospital Anxiety and Depression scale [Assessed 5 years after recruitment]
- Psychological function measured using Impact of Event Scale - Revised (IES-R) [Assessed 1 year after recruitment]
- Psychological function measured using Impact of Event Scale - Revised (IES-R) [Assessed 2 years after recruitment]
- Psychological function measured using Impact of Event Scale - Revised (IES-R) [Assessed 5 years after recruitment]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Enrolled in the TEAM Phase III RCT Protocol.
Exclusion Criteria:
- There are no exclusion criteria.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Royal Prince Alfred Hospital | Camperdown | New South Wales | Australia | 2050 |
| 2 | John Hunter Hospital | Sydney | New South Wales | Australia | |
| 3 | Royal North Shore Hospital | Sydney | New South Wales | Australia | |
| 4 | Wollongong Hospital | Wollongong | New South Wales | Australia | |
| 5 | Sunshine Coast University Hospital | Birtinya | Queensland | Australia | |
| 6 | Mater Health | Brisbane | Queensland | Australia | |
| 7 | Mater Private Hospital | Brisbane | Queensland | Australia | |
| 8 | Caboolture Hospital | Caboolture | Queensland | Australia | |
| 9 | Redcliffe Hospital | Redcliffe | Queensland | Australia | 4020 |
| 10 | Toowoomba Hospital | Toowoomba | Queensland | Australia | |
| 11 | Launceston General Hospital | Launceston | Tasmania | Australia | |
| 12 | Geelong Hospital - Barwon Health | Geelong | Victoria | Australia | 3220 |
| 13 | Cabrini Hospital | Malvern | Victoria | Australia | 3144 |
| 14 | Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 15 | Alfred Hospital | Prahran | Victoria | Australia | 3004 |
| 16 | Sunshine Hospital | St Albans | Victoria | Australia | 3021 |
Sponsors and Collaborators
- Australian and New Zealand Intensive Care Research Centre
- Medical Research Institute of New Zealand
- National Health and Medical Research Council, Australia
- ANZICS Clinical Trials Group
Investigators
- Study Chair: Prof Carol Hodgson, ANZIC-RC
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Herridge MS, Tansey CM, Matté 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.
- Higgins AM, Pettilä 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.
- 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.
- 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.
- 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.
- 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;19:81. doi: 10.1186/s13054-015-0765-4.
- U1111-1195-3567-A9