Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000808246
Ethics application status
Approved
Date submitted
12/09/2009
Date registered
17/09/2009
Date last updated
9/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective controlled trial of effect of the use of the Modified Early Warning Score on morbidity and mortality rates
Scientific title
The effect of the modified early warning score on unplanned admissions to the intensive care unit in general medical and surgical patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient Deterioration 243821 0
Condition category
Condition code
Cardiovascular 239994 239994 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
4 months duration (February to June 2007).
The installation of a new observation chart into 4 wards (two at The Canberra Hospital and two at Calvary Hosptial) which was colour coded for a modified early warning score.
The modified early warning score was utilised as a track and trigger system whereby if the score reached more than 4, a junior doctor was contacted by the bedside nurse to review and manage the patient within a 30 minute timeframe. The Medical Emergency Team (MET) could be contacted if the patient fulfilled standard MET criteria.
In order for the wards to be part of the pilot program, more than 50% of the healthcare workers needed to have undertaken a novel education package, COMPASS. This was a program that bought physiology to the bedside and informed people of the use of the SBAR communication tool. (Situation, Background, Assessment, Response).
The data will be collected from case records of the patients in a deidentified manner.
Intervention code [1] 241292 0
Early detection / Screening
Comparator / control treatment
The historical group was obtained from the same four wards during the same part of calendar in 2006 (Feb to June 2006)
During this time, there was no change to the usual patient care so that there was no added education on the deteriorating patient and the general observation chart was utilised with no colour coding and no track and trigger system. Patient review relied on either the nurse contacting the doctor with their concerns or calling for a Medical Emergency Team (MET) if they fulfilled the standard criteria for a MET.
The data will be collected from the patient's case records in a deidentified manner.
Control group
Historical

Outcomes
Primary outcome [1] 240897 0
Unplanned admissions to the intensive care unit.
The data will be collected from the two hospitals' intensive care databases. Unplanned admissions are those that are not elective surgical patients or those that come from the emergency department.
Timepoint [1] 240897 0
Hospital Discharge
Secondary outcome [1] 257177 0
Hospital Mortality
Timepoint [1] 257177 0
Hospital Discharge
Secondary outcome [2] 257178 0
Patient Adverse Events
eg: Medical Emergency Team Review
From data from the hospitals' switch board and followed up with the relevant patient case record.
eg: Unexpected Death
From the hospitals' list of deaths and subsequent follow up with the relevant patient case record.
Cardiac Arrest
From data from the hospitals' switch board and followed up with the relevant patient case record.
Timepoint [2] 257178 0
Hospital Discharge
Secondary outcome [3] 257581 0
Frequency of Vital Sign Measurements
The patient records identified initially from four pilot wards admission data for the relevant time periods and then 25%randomly selected to record all vital sign measurements for the length of stay from the observation charts in the patients' case record.
Timepoint [3] 257581 0
Admission to hospital discharge

Eligibility
Key inclusion criteria
Admission to four pilot wards
Two from The Canberra Hospital
Two from Calvary Hospital ACT
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients admitted for palliative care
Aged under 18 years old

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 2006 0
2605

Funding & Sponsors
Funding source category [1] 243722 0
Government body
Name [1] 243722 0
ACT Health
Country [1] 243722 0
Australia
Primary sponsor type
Individual
Name
Mr Mark Cormack
Address
Chief Executive, ACT Health
11 Moore Street
Canberra
ACT 2601
Country
Australia
Secondary sponsor category [1] 237086 0
Individual
Name [1] 237086 0
Mr Ian Thompson
Address [1] 237086 0
Deputy Chief Executive, ACT Health
11 Moore Street
Canberra
ACT 2601
Country [1] 237086 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239609 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 239609 0
Ethics committee country [1] 239609 0
Australia
Date submitted for ethics approval [1] 239609 0
Approval date [1] 239609 0
22/02/2007
Ethics approval number [1] 239609 0
ETH1/07.120
Ethics committee name [2] 239610 0
Calvary HealthCare ACT
Ethics committee address [2] 239610 0
Ethics committee country [2] 239610 0
Australia
Date submitted for ethics approval [2] 239610 0
Approval date [2] 239610 0
22/02/2007
Ethics approval number [2] 239610 0
HREC 3-2007

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

Contacts
Principal investigator
Name 30040 0
Address 30040 0
Country 30040 0
Phone 30040 0
Fax 30040 0
Email 30040 0
Contact person for public queries
Name 13287 0
Dr Imogen Mitchell
Address 13287 0
Department of Intensive Care
The Canberra Hospital
Yamba Drive
Garran
ACT 2605
Country 13287 0
Australia
Phone 13287 0
+61 2 62443423
Fax 13287 0
+61 2 62443507
Email 13287 0
imogen.mitchell@act.gov.au
Contact person for scientific queries
Name 4215 0
Dr Imogen Mitchell
Address 4215 0
Department of Intensive Care
The Canberra Hospital
Yamba Drive
Garran
ACT 2605
Country 4215 0
Australia
Phone 4215 0
+61 2 62443423
Fax 4215 0
+61 2 62443507
Email 4215 0
imogen.mitchell@act.gov.au

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.