The Australian Clinical Trials Alliance (ACTA) announced the winner of the 2023 ACTA Trial of the Year Award at the International Clinical Trials Symposium on Monday evening. The spotlight shone on the Trial of Early Activity and Mobilisation (TEAM) as it emerged victorious, clinching this year's coveted award. With a room filled with distinguished peers, the announcement was met with resounding applause, acknowledging the exceptional contributions of the TEAM trial.

The Trial of the Year Award celebrates the vital role clinical trials have in advancing clinical practice and saving or improving patients' lives every year.

TEAM is a randomised, multicentre, multinational and multidisciplinary randomised controlled trial, funded by the NHMRC and the New Zealand HRC. Established in 2017, the trial provided evidence for the provision of rehabilitation and mobilisation of critically ill, mechanically ventilated patients. Immobilisation contributes substantially to the development of muscle weakness and wasting, factors that are linked with longer hospital stays, higher post-discharge mortality, and poor long-term functional recovery. More than forty percent of mechanically ventilated patients in ICU experience acquired weakness. The trial addressed a crucial evidence gap regarding this widespread ICU-related condition.

Early rehabilitation and mobilisation are a complex intervention that has been proposed to reduce ICU-acquired weakness and poor outcomes associated with it. Several single centre pilot studies have found a benefit, including a reduced length of hospital stay, improved physical function at hospital discharge and improved cognitive function and HRQoL at 6-months. At least seven international clinical practice guidelines (SCCM USA, NICE UK, ESICM Europe) have advocated for early rehabilitation and mobilisation, despite the lack of evidence from a well conducted Phase III trial.

The award-winning trial led by Chief Investigator Professor Carol Hodgson, oversaw a team of Australian researchers and clinicians, in collaboration with several international partners. The multidisciplinary trial obtained key leadership from a team of medical doctors, nurses, physiotherapists, consumers, health economists, project managers and statisticians. Few other trials have included a multidisciplinary team to deliver a complex intervention in intensive care.

The investigating team worked with several hospitals in different countries, including the United Kingdom, New Zealand, Ireland, Brazil, and Europe, and included 750 critically ill patients to compare the effects of early physical therapy to standard care. The trial found no difference between early activity and standard care in terms of the number of days patients were alive and out of the hospital after 180 days. The study found that patients who received early activity were more likely to experience adverse events such as heart rhythm issues, low blood pressure and low oxygen levels.

Professor Hodgson highlighted that eight international guidelines recommend early mobilisation or rehabilitation in critically ill patients receiving mechanical ventilation, without evidence for the optimal dose.

“The TEAM trial, led by a multidisciplinary team questioned the dose of mobilisation in ICU,” said Professor Hodgson.

“We found that a high dose of mobilisation increased adverse events without improving days alive and at home compared to usual care mobilisation.

The findings of the trial now influence how medical professionals take care of critically ill patients in ICUs around the world. It suggests that activity and mobilisation delivered as usual care in Australia is a safer approach than a much higher and more intensive amount.

In addition, millions of dollars per year are now being saved in healthcare costs across Australia and New Zealand alone.

“This finding saves the healthcare system approximately $110 million per annum and reduces the risk of harm to critically ill patients,” Professor Hodgson added.

ACTA Deputy Chair Professor Chris Reid said, “Prof Hodgson and her team have made a direct and significant impact for patient outcomes and the financial burden on the healthcare system, and their findings have the potential to be replicated in healthcare settings across the world”.

“Our role at ACTA is to bring together those who are involved in the nation’s investigator-led clinical trials, and these Awards are a way to celebrate and recognise their extraordinary efforts for better patient outcomes, added Professor Reid.

Full detail on the awards, winners and finalists are available on request.

2023 ACTA Awards:

•Trial of the Year Award Winner: TEAM
Treatment of Invasively Ventilated Adults with Early Mobilisation Activity and Mobilisation (TEAM) is arandomised, multicentre, multinational and multidisciplinary randomised controlled trial.

•Trial of the Year Award Finalist: SuDDICU Australia
The effect of selective decontamination of the digestive tract on hospital mortality in critically illpatients receiving mechanical ventilation.

•Trial of the Year Award Finalist: Effect of audit and feedback on rates and musculoskeletaldiagnostic imaging requests by Australian general practitioners
Investigation into the effectiveness of audit and feedback, used at a national level, for reducingrequests for 11 overused musculoskeletal diagnostic imaging tests by Australian GPs compared withno intervention control. A factorial cluster randomised controlled trial.

•Excellence in Trials Statistics Award Winner: ASCOT
Australasian COVID-19 Trial (ASCOT) is an adaptive platform trial for non-critically ill patientshospitalised with COVID-19. The investigators tested different levels of anticoagulation (bloodthinning) and a novel antiviral agent called nafamostat.

•Excellence in Trials Statistics Award Finalist: CRISTAL
A cluster-randomised, crossover, noninferiority trial of aspirin compared to low-molecular-weightheparin for venous thromboembolism prophylaxis in hip or knee arthroplasty.

•Consumer Involvement Award Winner: ACCELERATE
ACCELERATE Plus Trial: a stepped-wedge cluster randomised controlled trial to assess the effect ofimproving patient assessment and clinical communication on patient adverse events.

•Health Economics Alongside Trials Winner: TARGET-D
Economic evaluation of the Target-D Platform to match depression management to severity prognosisin primary care.