ICU Recovery in Australian Patients

NCT ID: NCT02225938

Last Updated: 2023-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

262 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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)

Conditions

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Intensive Care Unit Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Intensive care survivors

Patients surviving an admission to an intensive care unit

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Monash University

OTHER

Sponsor Role collaborator

Australian and New Zealand Intensive Care Research Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carol Hodgson, PhD MRes

Role: PRINCIPAL_INVESTIGATOR

ANZIC-RC

Locations

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Monash Medical Centre

Clayton, Victoria, Australia

Site Status

The Austin Hospital

Heidelberg, Victoria, Australia

Site Status

Cabrini Hospital

Malvern, Victoria, Australia

Site Status

The Alfred Hospital

Melbourne, Victoria, Australia

Site Status

Epworth Hospital

Richmond, Victoria, Australia

Site Status

Countries

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Australia

References

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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.

Reference Type DERIVED
PMID: 28534110 (View on PubMed)

Other Identifiers

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SGS15-0104

Identifier Type: -

Identifier Source: org_study_id

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