Clinical trial NCT02225938: ICU Recovery in Australian Patients
Official title: ICU Recovery: A Multicentre Cohort Study in Critically Ill Patients to Determine Functional Recovery and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Syndrome
Keywords: Intensive Care
Recovery
Long term outcome
Function
Lead sponsor: Australian and New Zealand Intensive Care Research Centre
Sponsor class: OTHER
Collaborators: name: Monash University
First posted: 2014-08-26
Enrollment: 262
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 300 critically ill patients who were mechanically ventilated \>24 hours in an intensive care unit who have survived to hospital discharge.

Brief summary: Increasingly patients with critical illness requiring life support in an intensive care unit are surviving their hospital admission. Currently the investigators do not know what effect the ICU admission, and the life support, has on their long-term quality of life and whether they can return to their pre-illness level of function following ICU.

The investigators aim to test telephone follow-up of ICU survivors in assessing function and quality of life six months after ICU admission. Additionally, the investigators will identify if there are factors that lead to poor recovery. The investigators hope this can influence and change current ICU practice to improve recovery and long-term outcomes for patients.

The investigators aim to select a total of 300 patients from ICU, 75 patients from each of the four ICUs. If they survive to hospital discharge, patients and their relatives will receive a telephone questionnaire at 6 months after the ICU admission that aims to assess their long-term outcomes, including physical, cognitive and emotional function, quality of life, and whether they have been able to return to work following ICU.

Detailed description: The ICU Recovery program will measure psychological, functional and cognitive function and quality of life with health economic outcomes in critically ill patients 6 months after ICU admission. The initial pilot study will determine feasibility of the patient outcomes and measurement methods used. The study will consist of patients from three (3) Monash Partners ICUs (2 public and 1 private) as well as The Austin Hospital ICU. 10,000 ICU patients are managed by Monash Partners Academic Health Science Centre (MPAHSC) public and private hospitals each year, of which in the region of 8,500 patients survive. These patients add to the community burden and also influence community and rehabilitation costs. Ultimately, our goal is to establish a national National Health \& Medical Research Council (NHMRC) -funded interventional study, led by Monash Partners. Our aim is to improve long-term patient outcomes through: improving sedation practices, delirium prevention, neurocognitive stimulation, early mobilisation, post-ICU follow-up, and functional and psychological rehabilitation. This study is required for the evaluation of hospital and post-ICU rehabilitation practice as there is insufficient evidence to alter current clinical practice.

OBJECTIVES

Primary Aim:

To determine the feasibility of the multi-centre ICU Recovery study using telephone follow-up to assess quality of life, global, psychological, cognitive and physical outcomes at six months following ICU admission.

Secondary Aims

1. To determine the recovery of ICU patients ventilated \>24 hours at 6 months after ICU admission
2. To identify risk factors for poor recovery in ICU patients

Tertiary Aims

1. To establish the likely recruitment rate for future studies of long-term outcomes
2. To establish the resource requirements for long term follow-up (including staff, equipment and time taken for survey completion)

Eligibility criteria: Inclusion Criteria:

* ICU patients who have been invasively mechanically ventilated for over 24 hours

Exclusion Criteria:

* Patients aged less than 18 years old
* A proven or suspected acute primary brain process that is likely to result in global impairment of conscious level or cognition (e.g. traumatic brain injury, subarachnoid haemorrhage, stroke or hypoxic brain injury after cardiac arrest)
* Second or subsequent admission to ICU during a single hospital admission
* Death is deemed imminent and inevitable
* Participants who do not speak English

Primary outcomes:
measure: Feasibility of telephone interview
timeFrame: At completion of telephone interview, expected average of 6 months
Secondary outcomes:
measure: Health related quality of life
timeFrame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
Other outcomes:
measure: Pre-ICU function
timeFrame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
measure: Global function
timeFrame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
measure: Physical activity
timeFrame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
measure: Cognitive function
timeFrame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
measure: Anxiety and depression
timeFrame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
measure: Return to work
timeFrame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
Locations:
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Heidelberg
country: Australia
facility: The Austin Hospital
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Richmond
country: Australia
facility: Epworth Hospital
state: Victoria
Study officials:
affiliation: ANZIC-RC
name: Carol Hodgson, PhD MRes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hodgson CL, Udy AA, Bailey M, Barrett J, Bellomo R, Bucknall T, Gabbe BJ, Higgins AM, Iwashyna TJ, Hunt-Smith J, Murray LJ, Myles PS, Ponsford J, Pilcher D, Walker C, Young M, Cooper DJ. The impact of disability in survivors of critical illness. Intensive Care Med. 2017 Jul;43(7):992-1001. doi: 10.1007/s00134-017-4830-0. Epub 2017 May 22.