The TEAM Long-Term Cohort Study (A Sub-study of TEAM(III))

NCT05298982 | Enrolling By Invitation

• 1 other identifier: U1111-1195-3567-A9
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 16

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.

Conditions

Critically Ill; Mechanical Ventilation; Long Term Outcome

Keywords

Early activity and mobilization; rehabilitation; intensive care; health status

Outcome Measures

Primary Outcomes (1)

• Level of disability measured with the World Health Organisation's Disability Assessment Schedule (WHODAS) 2.0

  level of disability as measured by the World Health Organisation's Disability Schedule 2.0, 2 level (WHODAS) at 2 years after recruitment.

  Assessed 2 years after recruitment

Secondary Outcomes (21)

• 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

Study Arms (2)

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

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.

Interventions

Early activity and Mobilisation Intervention BEHAVIORAL

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

Intervention arm: TEAM protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Enrolled in the TEAM Phase III RCT Protocol.

Sponsors & Collaborators

• Australian and New Zealand Intensive Care Research Centre: lead
• Medical Research Institute of New Zealand: collaborator
• National Health and Medical Research Council, Australia: collaborator
• ANZICS Clinical Trials Group: collaborator

Study Sites (16)

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

John Hunter Hospital

Sydney, New South Wales, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, Australia

Location

Wollongong Hospital

Wollongong, New South Wales, Australia

Location

Sunshine Coast University Hospital

Birtinya, Queensland, Australia

Location

Mater Health

Brisbane, Queensland, Australia

Location

Mater Private Hospital

Brisbane, Queensland, Australia

Location

Caboolture Hospital

Caboolture, Queensland, Australia

Location

Redcliffe Hospital

Redcliffe, Queensland, 4020, Australia

Location

Toowoomba Hospital

Toowoomba, Queensland, Australia

Location

Launceston General Hospital

Launceston, Tasmania, Australia

Location

Geelong Hospital - Barwon Health

Geelong, Victoria, 3220, Australia

Location

Cabrini Hospital

Malvern, Victoria, 3144, Australia

Location

Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

Alfred Hospital

Prahran, Victoria, 3004, Australia

Location

Sunshine Hospital

St Albans, Victoria, 3021, Australia

Location

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• TEAM study website

MeSH Terms

Conditions

Critical Illness; Motor Activity

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Prof Carol Hodgson

  ANZIC-RC

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 28, 2022
• Study Start: February 11, 2020
• Primary Completion: November 1, 2023
• Study Completion (Estimated): November 1, 2026
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (16)