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Trial registered on ANZCTR


Trial ID
ACTRN12613000607774
Ethics application status
Approved
Date submitted
23/05/2013
Date registered
28/05/2013
Date last updated
10/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of point-of-care testing on cardiovascular risk assessment completion in primary care practice-EPOCH
Scientific title
The impact of point-of-care testing on cardiovascular risk assessment completion in primary care practice-a prospective, cluster randomised trial of 20 GP practices in NZ.
Secondary ID [1] 282562 0
N/A
Universal Trial Number (UTN)
Trial acronym
EPOCH-Evaluating a Point-Of-Care device in Heart Healthcare
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 289230 0
Point of care testing 289231 0
Condition category
Condition code
Cardiovascular 289564 289564 0 0
Coronary heart disease
Public Health 289580 289580 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention study. 10 GP practices using the cobas b101 POC device to test HbA1c and Cholesterol levels in eligible patients in order to complete CVD risk assessment records. A GP or practice nurse at each center will administer the test using standard diagnostic cartridges and a blood sample obtained by pin prick. The number of completed and non-completed cardiovascular risk profiles of primary health patients achieved using point of care testing over a 12 month period will be compared between the two groups.
Intervention code [1] 287226 0
Treatment: Devices
Intervention code [2] 287240 0
Early detection / Screening
Comparator / control treatment
10 GP practices using standard traditional lab-based tests results for HbA1c and Cholesterol, collected prospectively over the 12 month period will be used to complete the CVD risk assessments. The number of completed and non-completed cardiovascular risk profiles of primary health patients achieved using traditional lab -based test results, over a 12 month period will be compared to the POC testing and CVD risk assessments.
Control group
Active

Outcomes
Primary outcome [1] 289659 0
The number of Completed CVD risk assessments obtained from the anonymised GP medical records in both groups using the Predict software programme for collecting cardiovascular risk assessments.
Timepoint [1] 289659 0
12 months
Secondary outcome [1] 302965 0
Incomplete "parked" CVD risk assessments obtained from the anonymised GP medical records in both groups using the Predict software programme for collecting cardiovascular risk assessments.
Timepoint [1] 302965 0
At 12 months
Secondary outcome [2] 302966 0
Average time to complete CVD risk assessment obtained from the anonymised GP medical records in both groups using the Predict software programme for collecting cardiovascular risk assessments.
Timepoint [2] 302966 0
At 12 months
Secondary outcome [3] 302967 0
Cost analysis of POC device use versus Lab based results for completing CVD risk assessments using cost information provided by PHO's and local laboratories.
Timepoint [3] 302967 0
Over 12 months

Eligibility
Key inclusion criteria
Male or female are aged at least 35 years and less than 80 years old, and meet New Zealand national age, gender and ethnicity guideline criteria for CVD risk assessment and repeat assessment
Minimum age
35 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- are under 35 years old
- are 80 years old or older
- are not eligible for CVD risk assessment

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
20 GP practices will be randomly allocated to the standard practice of lab-based HbA1c and cholesterol testing or using the POC cobas b 101 machine situated in the practice, to obtain HbA1c and Cholesterol test results. Eligible participants identified at each GP practice will be made aware of the method of obtaining the results in order to complete an nationally required CVD risk assessment. GP practices will be allocated two one of the two groups via phoning the study statistician who will hold the allocation schedule at the administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participating practices will be randomised by the study statistician into one of two groups. Randomisation using dynamic adaptive methods will be stratified by practice size (number of GPs) and the rurality of the location (urban or rural).
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
The primary outcome is whether the eligible patients have had a completed CVD risk assessment during a one-year study period. We assume a primary event rate of 70% in the laboratory group and a 10-15% increase to 85% in the POC group. This figure is based on a study set in community pharmacies where POC testing for cholesterol risk management led to a 10% increase a 5% two-sided level of significant test and study power of 90%, we estimate a minimum sample size of 1000 patients is needed

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 5099 0
New Zealand
State/province [1] 5099 0
Northland

Funding & Sponsors
Funding source category [1] 287338 0
Commercial sector/Industry
Name [1] 287338 0
Roche Diagnostics International Ltd

Address [1] 287338 0
Roche Diagnostics International Ltd
Forrenstrasse 2
6343 Rotkreuz
Switzerland
Country [1] 287338 0
Switzerland
Primary sponsor type
University
Name
University of Auckland
Address
National Institute for Health Innovation
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 286088 0
None
Name [1] 286088 0
Address [1] 286088 0
Country [1] 286088 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289316 0
Health and Disability Ethics Committees
Ethics committee address [1] 289316 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington 6011
Ethics committee country [1] 289316 0
New Zealand
Date submitted for ethics approval [1] 289316 0
03/06/2013
Approval date [1] 289316 0
24/06/2013
Ethics approval number [1] 289316 0
13/NTB/79/AM02

Summary
Brief summary
To measure the impact of point of care testing for lipids (TC/HDL) and diabetes (HbA1c) on the frequency of completed cardiovascular disease (CVD) risk assessments in the eligible population in primary care practices in Northland region, New Zealand
Trial website
Trial related presentations / publications
Manuscript in draft only so not applicable at this time
Public notes

Contacts
Principal investigator
Name 40290 0
Dr Susan Wells
Address 40290 0
Epidemiology and Biostatistics
School of Population Health
University of Auckland
Private Bag 92019
Auckland 1142, New Zealand



Country 40290 0
New Zealand
Phone 40290 0
+64 9 923 2463
Fax 40290 0
+64 9 373 1710
Email 40290 0
s.wells@auckland.ac.nz
Contact person for public queries
Name 40291 0
Dr Sue Wells
Address 40291 0
Epidemiology and Biostatistics School of Population Health University of Auckland Private Bag 92019 Auckland 1142, New Zealand
Country 40291 0
New Zealand
Phone 40291 0
+64 9 923 2463
Fax 40291 0
+64 9 373 1710
Email 40291 0
s.wells@auckland.ac.nz
Contact person for scientific queries
Name 40292 0
Dr Sue Wells
Address 40292 0
Epidemiology and Biostatistics School of Population Health University of Auckland Private Bag 92019 Auckland 1142, New Zealand
Country 40292 0
New Zealand
Phone 40292 0
+64 9 923 2463
Fax 40292 0
+64 9 373 1710
Email 40292 0
s.wells@auckland.ac.nz