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NCT Number: NCT02225938

ICU Recovery in Australian Patients

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.

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Key information

Conditions

Intensive Care Unit Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Monash Medical Centre, Clayton, Victoria, Australia

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About this study

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

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

Tertiary Aims

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Feasibility of telephone interview

    Time frame: At completion of telephone interview, expected average of 6 months

    Determine feasibility of using a telephone interview to ascertain the functional recovery and quality of life and critically ill ICU survivors.

Secondary outcomes

  1. Health related quality of life

    Time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

    Health related quality of life (HRQOL) measured with EuroQol five dimensions questionnaire (EQ-5D) before ICU (retrospective survey) and at 6 months (prospective survey)

Other outcomes

  1. Pre-ICU function

    Time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

    Pre-ICU function measured with EuroQol five dimensions questionnaire (EQ-5D) and work details

  2. Global function

    Time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

    Global function at 6 months, assessed with World Health Organization Disability Assessment Schedule (WHODAS)

  3. Physical activity

    Time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

    Physical activity at 6 months, assessed with International Physical Activity Questionnaire (IPAQ).

  4. Cognitive function

    Time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

    Cognitive function at 6 months, assessed with Telephone Interview for Cognitive Status (TICS).

  5. Anxiety and depression

    Time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

    Anxiety and depression at 6 months will be assessed with the Hospital Anxiety and Depression Scale (HADS) and the Impact of Event Scale (IES-R)

  6. Return to work

    Time frame: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit

    Return to work at 6 months

Sponsors and collaborators

Lead sponsor

Australian and New Zealand Intensive Care Research Centre

Other

Collaborators

  • Monash University

Registry information

Official study title

ICU Recovery: A Multicentre Cohort Study in Critically Ill Patients to Determine Functional Recovery and Quality of Life

Acronym: ICU-RECOVERY

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 26, 2014
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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