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Trial registered on ANZCTR


Registration number
ACTRN12616000963426
Ethics application status
Approved
Date submitted
5/07/2016
Date registered
21/07/2016
Date last updated
21/07/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical decision making in intensive care units for starting early rehabilitation.
Scientific title
Determining the factors that influence clinical decision making of when to commence early rehabilitation in intensive care units
Secondary ID [1] 289351 0
Nil known
Universal Trial Number (UTN)
U1111-1183-7122
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Critical Illness 298979 0
early rehabilitation 298981 0
Condition category
Condition code
Physical Medicine / Rehabilitation 299044 299044 0 0
Physiotherapy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Prospective evaluation of clinical decision making in critically ill patients.
Prospectively evaluate all the factors that influence clinical decision making of when to commence early rehabilitation in intensive care units. These factors will be identified through an extensive literature review and consultation with international experts who have published in the area of early rehabilitation in critically ill patients. Doctors, Nurses and Physiotherapists will be asked if the patient in front of them is ready to complete early mobilisation. If the therapist responds "No" they will then be asked to rank the factors that have influenced their decision. The duration of clinician involvement will be the time it takes to come to their decision each day. The participant who the decision is being made about will remain in the study for duration of their ICU stay or until 3 consecutive days of rehab occur.
Intervention code [1] 294927 0
Not applicable
Comparator / control treatment
No control treatment as the study is a prospective observational study of critically ill patients.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298509 0
Prospective evaluation of the factors that influence a clinician's decision to commence early rehabilitation in ICU utilising a specifically designed data collection tool created following an extensive literature review and international expert consultation to identify potential influential factors..
Timepoint [1] 298509 0
Daily ICU consultation for 20 days or until three consecutive days of rehabilitation occur.
Secondary outcome [1] 325750 0
Describe the early rehabilitation (duration, highest function level, personnel and equipment) completed by observed patients
Timepoint [1] 325750 0
Rehabilitation completed in ICU until three consecutive days of rehabilitation occur.

Eligibility
Key inclusion criteria
Observed Patient inclusion criteria
Predicted to be mechanically ventilated for greater 48 hours.
Predicted intensive care unit length of stay greater than or equal to 48 hours (as per ICU consultant prediction)

Medical, Nursing and Physiotherapist inclusion criteria
Any healthcare provider involved in decision making must hold tertiary degree (or equivalent) in area of practice.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Observed Patient exclusion criteria
Known primary systemic neuromuscular disease or intracranial process on admission (as this limits the patient's ability to complete early rehabilitation and alters the clinican's decision making process).

Doctors, Nurses and Physiotherapists exclusion criteria.
Nil.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Following discussion with the team statistician, Leonid Churilov and a senior ICU clinicians, the use of three different decision makers and twelve outcome variables, 1420 observations were required to allow sufficient splitting of nodes in a classification and regression analysis as the splitting of nodes ceases when the node arrived at is relatively homogeneous in relation to the outcome variable, or contains too few observations. One thousand four hundred and twenty observations will mean cessation at a node is dependent on node homogeneity relating to the variable rather than a consequence of too few observations. No formal power calculation was performed.

Descriptive statistics using frequencies and percentages will be used for categorical data. For continuous data mean and standard deviation or median and inter-quartile range for non-parametric data will be recorded. Weighted Kappas, Student t-tests and Mann-Whitney U tests will be used to determine differences between groups for continuous variables. Pearson chi square test of independence will be used to analyse the difference between categorical data. Alpha will be set at p<0.05

Classification and regression tree (CART) analysis to determine the best discriminating variables to predict whether a patient was ready to commenced early rehab

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 5903 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 5904 0
Western Hospital - Footscray
Recruitment hospital [3] 5905 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 5906 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment postcode(s) [1] 13347 0
3084 - Heidelberg
Recruitment postcode(s) [2] 13348 0
3011 - Footscray
Recruitment postcode(s) [3] 13349 0
3052 - Parkville
Recruitment postcode(s) [4] 13350 0
2010 - Darlinghurst

Funding & Sponsors
Funding source category [1] 293742 0
Government body
Name [1] 293742 0
NHMRC
Address [1] 293742 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 293742 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Sue Berney
Address
Austin Health
Studley Road,
Heidelberg, Vic, 3084
Country
Australia
Secondary sponsor category [1] 292572 0
None
Name [1] 292572 0
Not applicable
Address [1] 292572 0
Not applicable
Country [1] 292572 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295179 0
Austin Health
Ethics committee address [1] 295179 0
Austin Health
145 Studley Rd,
Heidelberg VIC 3084
Ethics committee country [1] 295179 0
Australia
Date submitted for ethics approval [1] 295179 0
27/03/2013
Approval date [1] 295179 0
24/04/2013
Ethics approval number [1] 295179 0
H2013/05021

Summary
Brief summary
Survivors of the intensive care unit (ICU) can suffer long standing impairments in physical function. Rehabilitation provided in the ICU has been shown to improve physical function outcomes at both hospital discharge and 12-months. Early rehabilitation has been shown to be safe and feasible and may help prevent the long term sequelae. However, early rehabilitation is not routinely implemented in ICU due to cultural barriers and a lack of well-defined safety parameters, it currently relies on the discretion of the clinicians caring for the patient. Clinician's decisions can be influenced by conventional wisdom, personal experience, intuition and knowledge. The factors that clinicians consider to be important in the decision to provide rehabilitation, particularly out of bed functional activities in the ICU, are currently unknown. Therefore we aim to identify the factors that influence the initiation of early rehabilitation and develop a decision making support tree that includes safety parameters to assist clinicians in the provision of early rehabilitation for patients in ICU.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66362 0
A/Prof Sue Berney
Address 66362 0
Austin Health
145 Studley Road,
Heidelberg, Vic 3084
Country 66362 0
Australia
Phone 66362 0
+61 394963070
Fax 66362 0
Email 66362 0
sue.berney@austin.org.au
Contact person for public queries
Name 66363 0
Miss Joleen Rose
Address 66363 0
Austin Health
145 Studley Road,
Heidelberg, Vic 3084
Country 66363 0
Australia
Phone 66363 0
+61 39496 6778
Fax 66363 0
Email 66363 0
joleen.rose@austin.org.au
Contact person for scientific queries
Name 66364 0
A/Prof Sue Berney
Address 66364 0
Austin Health
145 Studley Road,
Heidelberg, Vic 3084
Country 66364 0
Australia
Phone 66364 0
+61 39496 3070
Fax 66364 0
Email 66364 0
sue.berney@austin.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary