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Trial registered on ANZCTR


Registration number
ACTRN12611001228976
Ethics application status
Approved
Date submitted
29/11/2011
Date registered
30/11/2011
Date last updated
9/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of an Integrated Point of Care Testing service in the Emergency Department: a randomised trial
Scientific title
Impact of an Integrated Point of Care Testing service for patients presenting to the Emergency Department on time to disposition decision: a randomised trial
Secondary ID [1] 273465 0
NIL
Universal Trial Number (UTN)
U1111-1126-0569
Trial acronym
IPoCT in the ED
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Time taken for a disposition decision to be reached by doctors treating emergency depatment patients. 279253 0
Condition category
Condition code
Public Health 279454 279454 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is to process blood tests of emergency department patients who meet inclusion/exclusion criteria using a point of care blood analyser stationed within the emergency department. The blood tests available are haemoglobin, electrolytes, creatinine, calcium, glucose, INR, troponin, D-Dimer, beta-HCG. Patient may recieve one or more of theses tests, but only once as part of their emergency department evaluation. Patients are involved in the study only as long as it takes for their doctor to make an admission or discharge decision (typically several hours at most).
Patients will be recruited over a period of 8 months.
Intervention code [1] 283790 0
Treatment: Devices
Intervention code [2] 283806 0
Early detection / Screening
Comparator / control treatment
The control arm will have their required blood tests processed in the usual way using the central laboratory service. This involves taking a blood sample by venepuncture or via an intravenous cannula, generating a request form, and sending both the bllod sample and paperwork to the central laboratory via a pneumatic tube delivery system.
Control group
Active

Outcomes
Primary outcome [1] 286021 0
Time to admission/discharge decision
Timepoint [1] 286021 0
Measured at time of admission/discharge decision
Secondary outcome [1] 295008 0
Length of stay in ED
Timepoint [1] 295008 0
Measured at time patient leaves the ED
Secondary outcome [2] 295009 0
Time to admission/discharge decision for patients with acute coronary syndrome
Timepoint [2] 295009 0
Measured at time of admission/discharge decision
Secondary outcome [3] 295010 0
Length of stay for those sent home from ED
Timepoint [3] 295010 0
Measured at time patient leaves the ED
Secondary outcome [4] 295011 0
Length of stay for those sent to emergency short stay ward
Timepoint [4] 295011 0
Measured at time patient leaves the ED
Secondary outcome [5] 298168 0
Economic evaluation
Timepoint [5] 298168 0
All costs from time of arrival to ED to the time of departure from the ED

Eligibility
Key inclusion criteria
1.Age greater or equal to 18 years
2.Presenting to the Emergency department
3.Suspected acute coronary syndrome, or patient only requires blood tests that are available on point of care analyser
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Acute ST elevation mycardial infarct

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study allocation will be recorded on a sheet of paper, each sheet sealed inside opaque sequentially numbered envelopes. These will be stored with the team co-ordinator in the ED. When a patient meets inclusion criteria, the staff member enrolling the patient will ask the team co-ordinator for an allocation envelope. The team co-ordinator will take the next envelope in the sequence and give this to the treating doctor to open.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We will use a stratified block randomisation method to ensure balanced numbers of participants in each arm of the study. There will be two strata (those patients suspected of an acute coronary syndrome, and all other patient appropriate for point of care testing). Given that this study is unblinded, random block sizes will be used to prevent the possibility of predicting the allocation sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/12/2011
Actual
12/12/2011
Date of last participant enrolment
Anticipated
28/02/2012
Actual
26/04/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
620
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284279 0
Government body
Name [1] 284279 0
Ministerial taskforce for Emercency Care (MTEC)
Country [1] 284279 0
Australia
Primary sponsor type
Hospital
Name
Sty George Hospital
Address
Gray St,
Kogarah, NSW, 2217
Country
Australia
Secondary sponsor category [1] 283230 0
None
Name [1] 283230 0
Address [1] 283230 0
Country [1] 283230 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286238 0
South Eastern Sydney and Illawarra Area Health Service Human Research Ethics Committee Central
Ethics committee address [1] 286238 0
Ethics committee country [1] 286238 0
Australia
Date submitted for ethics approval [1] 286238 0
11/10/2011
Approval date [1] 286238 0
18/11/2011
Ethics approval number [1] 286238 0
HREC/11/STG/170

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

Contacts
Principal investigator
Name 33436 0
Dr Dr Stephen Asha
Address 33436 0
Emergency Department St George Hospital Gray St, Kogarah, 2217 NSW
Country 33436 0
Australia
Phone 33436 0
+61 2 9113 1650
Fax 33436 0
+61 2 9113 1505
Email 33436 0
stephen.asha@sesiahs.health.nsw.gov.au
Contact person for public queries
Name 16683 0
Dr Stephen Asha
Address 16683 0
Emergency Department
St George Hospital
Gray St, Kogarah, 2217
NSW
Country 16683 0
Australia
Phone 16683 0
+61 2 9113 1650
Fax 16683 0
+61 2 9113 1505
Email 16683 0
stephen.asha@sesiahs.health.nsw.gov.au
Contact person for scientific queries
Name 7611 0
Dr Stephen Asha
Address 7611 0
Emergency Department
St George Hospital
Gray St, Kogarah, 2217
NSW
Country 7611 0
Australia
Phone 7611 0
+61 2 9113 1650
Fax 7611 0
+61 2 9113 1505
Email 7611 0
stephen.asha@sesiahs.health.nsw.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.