Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001092785
Ethics application status
Approved
Date submitted
23/09/2013
Date registered
30/09/2013
Date last updated
2/03/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
A four-stage quality improvement study aimed at increasing the frequency of mobilisation of patients in the Royal Adelaide Hospital Intensive Care Unit: Parts 1 and 4
Scientific title
A four-stage quality improvement study aimed at increasing the frequency of mobilisation of patients in the Royal Adelaide Hospital Intensive Care Unit: Parts 1 and 4
Secondary ID [1] 283284 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mobilisation of Intensive Care Unit patients 290159 0
Condition category
Condition code
Physical Medicine / Rehabilitation 290551 290551 0 0
Physiotherapy
Public Health 290588 290588 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The participants in Parts 1 and 4 of the study – the prospective audits – will comprise all patients in the Royal Adelaide Hospital Intensive Care Unit over the audit periods. Patients will receive usual care. The frequency of mobilisation, type of mobilisation, adverse events during mobilisation, staff involved in mobilisation and reasons mobilisation did not occur will be recorded. Audit 1 will occur for a 1 month period in November 2013. Audit 2 (Part 4) will occur for a 1 month period in June 2014.
A prospective staff survey investigating staff perceptions of the effectiveness of the quality improvement project will also be undertaken in June 2014 (Part 4 of the study). This will involve permanent/semi-permanent Royal Adelaide Hospital Intensive Care Unit staff (i.e. medical staff [consultants, senior registrars], nursing staff, physiotherapists. Return of the completed survey
will be taken as an indication of informed consent. The survey consists of a series of closed statements that require responses using a visual analogue scale and two open questions that explore perceived barriers
to the early progressive mobilisation of Intensive Care Unit patients. The survey will be distributed on a single occasion to relevant staff.
Intervention code [1] 288009 0
Not applicable
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290574 0
Frequency of mobilisation. Relevant data will be retrieved from patient observation sheets and/or medical records and/or recorded by physiotherapy staff in the physiotherapy workbooks that are currently used on a day-to-day basis by the Intensive Care Unit physiotherapists.
Timepoint [1] 290574 0
1-month audit periods.
Primary outcome [2] 290575 0
Type of mobilisation. Relevant data will be retrieved from patient observation sheets and/or medical records and/or recorded by physiotherapy staff in the physiotherapy workbooks that are currently used on a day-to-day basis by the Intensive Care Unit physiotherapists.
Timepoint [2] 290575 0
1-month audit periods.
Secondary outcome [1] 304813 0
Adverse events during mobilisation. Adverse events will include deterioration in conscious state, excessive increase/decrease in blood pressure, heart rate or percutaneous oxygen saturation, or a fall. Relevant data will be retrieved from patient observation sheets and/or medical records and/or recorded by physiotherapy staff in the physiotherapy workbooks that are currently used on a day-to-day basis by the Intensive Care Unit physiotherapists.
Timepoint [1] 304813 0
1-month audit periods.
Secondary outcome [2] 304814 0
Staff involved in mobilisation. Relevant data will be retrieved from patient observation sheets and/or medical records and/or recorded by physiotherapy staff in the physiotherapy workbooks that are currently used on a day-to-day basis by the Intensive Care Unit physiotherapists.
Timepoint [2] 304814 0
1-month audit periods.
Secondary outcome [3] 304815 0
Reasons mobilisation did not occur. Relevant data will be retrieved from patient observation sheets and/or medical records and/or recorded by physiotherapy staff in the physiotherapy workbooks that are currently used on a day-to-day basis by the Intensive Care Unit physiotherapists.
Timepoint [3] 304815 0
1-month audit periods.
Secondary outcome [4] 309160 0
A purpose-designed survey has been developed by the researchers to investigate staff perceptions of the success of the quality improvement project (Part 4).
Timepoint [4] 309160 0
One-off measurement (Part 4).

Eligibility
Key inclusion criteria
Audits (Part 1 and 4) will include all patients in the Royal Adelaide Hospital Intensive Care Unit during the two 1-month audit periods. The prospective staff survey (Part 4) will include medical, nursing and physiootherapy staff working in the Royal Adelaide Hospital Intensive Care Unit.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Descriptive analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2013
Actual
1/11/2013
Date of last participant enrolment
Anticipated
21/07/2014
Actual
30/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 1536 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 7375 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 288024 0
Self funded/Unfunded
Name [1] 288024 0
Country [1] 288024 0
Primary sponsor type
Individual
Name
Simone Dafoe
Address
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 286740 0
Individual
Name [1] 286740 0
Kathy Stiller
Address [1] 286740 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country [1] 286740 0
Australia
Secondary sponsor category [2] 286741 0
Individual
Name [2] 286741 0
Marianne Chapman
Address [2] 286741 0
Intensive Care Unit, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country [2] 286741 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289946 0
Royal Adelaide Hospital
Ethics committee address [1] 289946 0
Ethics committee country [1] 289946 0
Australia
Date submitted for ethics approval [1] 289946 0
Approval date [1] 289946 0
17/09/2013
Ethics approval number [1] 289946 0
HREC/13/RAH/376

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43206 0
Ms Simone Dafoe
Address 43206 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 43206 0
Australia
Phone 43206 0
61 8 82225334
Fax 43206 0
Email 43206 0
[email protected]
Contact person for public queries
Name 43207 0
Simone Dafoe
Address 43207 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 43207 0
Australia
Phone 43207 0
61 8 82225334
Fax 43207 0
Email 43207 0
[email protected]
Contact person for scientific queries
Name 43208 0
Simone Dafoe
Address 43208 0
Physiotherapy Department, Royal Adelaide Hospital, North Terrace, Adelaide, SA 5000
Country 43208 0
Australia
Phone 43208 0
61 8 82225334
Fax 43208 0
Email 43208 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.