Intensive Care Unit SyndromeICU-RECOVERYNCT02225938
ICU Recovery in Australian Patients
An observational study of Intensive Care Unit Syndrome, run by Australian and New Zealand Intensive Care Research Centre at 5 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome
- How many people
- 262 participants
- Where
- 5 sitesAustralia
- Study dates
- Aug 2014to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 300 critically ill patients who were mechanically ventilated >24 hours in an intensive care unit who have survived to hospital discharge.
Who may be able to join
- ICU patients who have been invasively mechanically ventilated for over 24 hours
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites
Monash Medical Centre
Clayton, Victoria, 3168
The Austin Hospital
Heidelberg, Victoria, 3084
Cabrini Hospital
Malvern, Victoria, 3144
The Alfred Hospital
Melbourne, Victoria, 3004
Epworth Hospital
Richmond, Victoria, 3121
About this study
Official title: ICU Recovery: A Multicentre Cohort Study in Critically Ill Patients to Determine Functional Recovery and Quality of Life
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.
Read the 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
- 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)
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- Intensive Care, Recovery, Long term outcome, Function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intensive care survivors | Patients surviving an admission to an intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of telephone interview
Determine feasibility of using a telephone interview to ascertain the functional recovery and quality of life and critically ill ICU survivors.
Measured: At completion of telephone interview, expected average of 6 months
Secondary outcomes (1)
Health related quality of life
Health related quality of life (HRQOL) measured with EuroQol five dimensions questionnaire (EQ-5D) before ICU (retrospective survey) and at 6 months (prospective survey)
Measured: At telephone interview, conducted at an expected average of 6 months following discharge from the Intensive Care Unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Australian and New Zealand Intensive Care Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Monash University
- Responsible party
- Sponsor
- Investigators
- Carol Hodgson, PhD MRes, Principal investigator, ANZIC-RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02225938
- Sponsor's protocol ID
- SGS15-0104
- Acronym
- ICU-RECOVERY
- Status last verified
- Aug 2018
- First submitted
- 6 Aug 2014
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28534110
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ICU Recovery: A Multicentre Cohort Study in Critically Ill Patients to Determine Functional Recovery and Quality of Life
- ClinicalTrials.gov ID
- NCT02225938
- Acronym / sponsor ID
- ICU-RECOVERY / SGS15-0104
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- Intensive Care, Recovery, Long term outcome, Function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Australian and New Zealand Intensive Care Research CentreUniversity, hospital or other
- Collaborators
- Monash University
- Study start
- Aug 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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)
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intensive care survivors | – | –Patients surviving an admission to an intensive care unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 300 critically ill patients who were mechanically ventilated >24 hours in an intensive care unit who have survived to hospital discharge.
Key inclusion criteria (1 listed)
- ICU patients who have been invasively mechanically ventilated for over 24 hours
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
- Derived from this study: PubMed 28534110Hodgson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carol Hodgson, PhD MRes principal investigator
ANZIC-RC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Syndrome, run by Australian and New Zealand Intensive Care Research Centre at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of telephone interview (time frame: At completion of telephone interview, expected average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02225938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.