Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000617066
Ethics application status
Not yet submitted
Date submitted
22/07/2010
Date registered
28/07/2010
Date last updated
28/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Maternity early warning score and the frequency of vital sign measurement in maternity patients
Scientific title
In maternity patients does the introduction of a maternity early warning score have an impact on frequency of vital sign measurement and medical practitioner review.
Secondary ID [1] 252269 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frequency of vital sign measurement and medical review in maternity patients in the inpatient setting 257789 0
Condition category
Condition code
Other 257961 257961 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above
Other 257983 257983 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
1)Maternity early warning scores- this is a track and trigger system to detect vital signs that are outside the normal ranges expected and will be calculated when vital signs are done
2)a new observation chart- this will incorporate the early warning score as well as other information specific to maternity in-patients such as per vagina(pv) loss, protein in urine
3)education program about deteriorating maternity pateints including prelearning with a CD an manual and a 2 1/2 hour face to face session with lecture and case studies
The intervention period will run for 4 months once 50% of the clinical staff have completed the education program.
Intervention code [1] 256855 0
Other interventions
Intervention code [2] 256874 0
Early detection / Screening
Intervention code [3] 256875 0
Treatment: Other
Comparator / control treatment
Four months of data from the same period from the previous year will be compared to determine the interventions impact.
The data will be collected in four group, a historical group and a intervention group at each of the 2 hospitals
Control group
Historical

Outcomes
Primary outcome [1] 258827 0
Increased measurement of vital signs- medical records will be examined to collect data which will be entered in an Access database. Comparison of the 2009 group with the trial period to note changes.
Timepoint [1] 258827 0
Compare 4 months control period with 4 months trial period
Secondary outcome [1] 264930 0
Increased medical review- following collection of vital signs a early warning score will be calculated by the database. Any set of vital signs that have reach a trigger for medical review, a search of the medical record will be undertaken to see if a review was requested by the midwives and if a medical officer reviewed the woman. The two time periods will be compared.
Timepoint [1] 264930 0
Compare 4 months control period with 4 months trial period

Eligibility
Key inclusion criteria
Maternity pateints admitted as an inpatient
18 years and older
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18 years of age

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)
all patients who meet the criteria will be included,
historical comparison for those prior to interventions
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2010
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)

Funding & Sponsors
Funding source category [1] 257313 0
Hospital
Name [1] 257313 0
ACT Health
Country [1] 257313 0
Australia
Primary sponsor type
Hospital
Name
ACT Health
Address
Early recognition of the deteriorating patient program
Level 3, 11 Moore St
Canberra City ACT
2601
Country
Australia
Secondary sponsor category [1] 256558 0
None
Name [1] 256558 0
Address [1] 256558 0
Country [1] 256558 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 259342 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 259342 0
Building 10, Level 6
Canberra Hospital
Yamba Drive, Garran
Canberra, ACT 2605
Ethics committee country [1] 259342 0
Australia
Date submitted for ethics approval [1] 259342 0
23/07/2010
Approval date [1] 259342 0
Ethics approval number [1] 259342 0
Ethics committee name [2] 259343 0
Calvary Health Care Public Human Research & Ethics Committee
Ethics committee address [2] 259343 0
Calvary Health Care ACT
PO Box 254
Jamison ACT 2614
Ethics committee country [2] 259343 0
Australia
Date submitted for ethics approval [2] 259343 0
30/07/2010
Approval date [2] 259343 0
Ethics approval number [2] 259343 0

Summary
Brief summary
The study is to examine the impact of early warning scores, observation charts and education on the measurement of vital signs and subsequent review by medical staff.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31420 0
Address 31420 0
Country 31420 0
Phone 31420 0
Fax 31420 0
Email 31420 0
Contact person for public queries
Name 14667 0
Heather Mckay
Address 14667 0
Level 3, 11 Moore St
Canberra City
ACT 2601
Country 14667 0
Australia
Phone 14667 0
+ 61 2 6244 3885
Fax 14667 0
Email 14667 0
[email protected]
Contact person for scientific queries
Name 5595 0
Heather McKay
Address 5595 0
Level 3, 11 Moore St
Canberra City
ACT 2601
Country 5595 0
Australia
Phone 5595 0
+ 61 2 6244 3885
Fax 5595 0
Email 5595 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.