Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000659202
Ethics application status
Approved
Date submitted
23/07/2009
Date registered
4/08/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Paediatric Early Warning Score and the frequency of vital sign measurement in paediatric patients.
Scientific title
Paediatric Early Warning Score and the frequency of vital sign measurement in paediatric patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early detection of deterioration in vital signs in paediatric inpatients 237347 0
Condition category
Condition code
Other 239668 239668 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the introduction of the new, age appropriate observation charts on wards 4A and 4B with the ability to record an early warning score and an associated education package. 4 month trial in 2009.
The charts will be completed by nursing staff in the clinical inpatient areas when vital signs are done. The chart is different based on the age of the child, < 3months, 3-11 months, 1-4 years, 5-11 years, 12-17 years.
Intervention code [1] 237009 0
Other interventions
Comparator / control treatment
4 month control period retrospectively in 2008. This information will be collected retrospectively from medical records. It will compare the documentation on the old observation charts with the new charts as well as what actions were taken if there was a deterioration.
Control group
Historical

Outcomes
Primary outcome [1] 238442 0
1. To determine if the new observation charts increase the number of vital sign observations documented.
Timepoint [1] 238442 0
Outcomes to be measured at the end of a 4 month trial
Primary outcome [2] 240514 0
To determine whether the early identification of the deteriorating child results in more timely clinical interventions as indicatedby an improvement in the rate of Code Blue activation (Medical Emergency TeamMET)
Timepoint [2] 240514 0
Outcomes to be measured at the end of a 4 month trial
Primary outcome [3] 240515 0
To determine whether the early identification of the deteriorating child results in more timely clinical interventions as indicatedby a reduction in unplanned admissions to the The Canberra Hospital (TCH) Intensive Care Unit or transfers to Neonatal or Paediatric Intensive Care Unit(ICU).
Timepoint [3] 240515 0
Outcomes to be measured at the end of a 4 month trial
Primary outcome [4] 240516 0
To determine whether the early identification of the deteriorating child results in more timely clinical interventions as indicatedby a reduction of in-hospital deaths where there is no do not resuscitate order
Timepoint [4] 240516 0
Outcomes to be measured at the end of a 4 month trial
Secondary outcome [1] 244947 0
To document the variance in the frequency of vital sign measurement and clinical actions before and after the intervention
Timepoint [1] 244947 0
Outcomes to be measured at the end of a 4 month trial

Eligibility
Key inclusion criteria
Paeditric inpatients up to and including 17 years in 2 inpatient wards
Minimum age
1 Days
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Palliated patients
Chronic care patients

Study design
Purpose of the study
Treatment
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)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
2009 particpants recieve all interventions, 2008 control group is retrospective therefore do no trecieve interventions
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/07/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237392 0
Hospital
Name [1] 237392 0
The Canberra Hospital
Country [1] 237392 0
Australia
Primary sponsor type
Hospital
Name
The Canberra Hospital
Address
PO Box 11
Woden, ACT
2601
Country
Australia
Secondary sponsor category [1] 236892 0
Government body
Name [1] 236892 0
ACT Health
Address [1] 236892 0
ERDP program
Level 3, 11 Moore St
Canberra City
2601
Country [1] 236892 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239524 0
ACT Health and Community Care Human Research Ethics Committee
Ethics committee address [1] 239524 0
Ethics committee country [1] 239524 0
Australia
Date submitted for ethics approval [1] 239524 0
13/10/2008
Approval date [1] 239524 0
23/10/2008
Ethics approval number [1] 239524 0
ETH.9/08.860

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

Contacts
Principal investigator
Name 29960 0
Address 29960 0
Country 29960 0
Phone 29960 0
Fax 29960 0
Email 29960 0
Contact person for public queries
Name 13207 0
Heather Mckay
Address 13207 0
Level 3, 11 Moore St
Canberra City
ACT 2600
Country 13207 0
Australia
Phone 13207 0
+61 2 6244 3885
Fax 13207 0
Email 13207 0
[email protected]
Contact person for scientific queries
Name 4135 0
Heather Mckay
Address 4135 0
Level 3, 11 Moore St
Canberra City
ACT 2600
Country 4135 0
Australia
Phone 4135 0
+61 2 6244 3885
Fax 4135 0
Email 4135 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.