The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Trial ID
ACTRN12605000272695
Ethics application status
Approved
Date submitted
23/08/2005
Date registered
2/09/2005
Date last updated
19/01/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Point of CARE testing in a general practice setting trial
Scientific title
A randomised controlled trial to evaluate the safety, clinical effectiveness and cost effectiveness of Point of Care testing in a general practice setting on the management of diabetes, anticoagulant therapy and hyperlipidaemia.
Universal Trial Number (UTN)
Trial acronym
PoCT trial in General Practice
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 359 0
Hyperlipidaemia and anticoagulantm therapy 360 0
Condition category
Condition code
Metabolic and Endocrine 421 421 0 0
Diabetes
Diet and Nutrition 422 422 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The primary purpose of the trial is to evaluate the clinical effectiveness, cost effectiveness and safety of PoCT in a general practice setting. There are two phases to the trial. In the first phase, patients in practices from the experimental group will have their testing performed both by pathology laboratories in the usual manner and by PoCT in general practice. In phase 2 of the trial, patients in the experimental group will be tested using only PoCT in their usual general practice.
Intervention code [1] 230 0
Treatment: Devices
Comparator / control treatment
The control group will undertake testing by pathology laboratories in accordance with the protocol of the trial. Phase 1 will go for 6 months.
Patients in the control group will continue to be tested as for phase 1. Phase 2 will go for 12 months.
Control group
Active

Outcomes
Primary outcome [1] 483 0
improved control for patients with lipids, diabetes and INR
Timepoint [1] 483 0
At 18 months
Secondary outcome [1] 1043 0
1) safety (competency, quality asurance, quality control and precision and accuracy)
Timepoint [1] 1043 0
6 months
Secondary outcome [2] 1044 0
2) Cost effectiveness of PoCT
Timepoint [2] 1044 0
18 months
Secondary outcome [3] 1045 0
3) Satisfaction with PoCT (GPs, patients, practice staff, other stakeholders).
Timepoint [3] 1045 0
17 month

Eligibility
Key inclusion criteria
Have an established disease. The criteria for categorising a patient as having established disease are: 1. Anticoagulant therapy patient has been prescribed warfarin and has had INR test results within the therapeutic range for at least one month (i.e. is stabilised). 2. Diabetes patient has had a fasting plasma glucose > = 7.0 mmol/L or 2-hour post glucose load >=11.1 mmol/L. 3. Hyperlipidaemia patient is, or has been, eligible for pharmaceutical benefits for lipid lowering drugs (statins).
Minimum age
18 Years
Maximum age
Not stated
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have significant cognitive impairment (eg dementia), and/or Patients unable to understand the instructions written in English, and/or patients who have poor insight into their disease process or physical disabilities.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/email after consent was obtained (recruiters did not know the sequence).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random allocation sequence was generated using Ralloc.ado version 3.2.5 in Stata 9.0. Randomisation was stratified by geographic area (urban, rural and remote) and used randomly permuted blocks of various sizes.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 474 0
Government body
Name [1] 474 0
Australian Government Department of Health and Ageing
Address [1] 474 0
Country [1] 474 0
Australia
Primary sponsor type
University
Name
Department of General Practice, The University of Adelaide
Address
Country
Australia
Secondary sponsor category [1] 381 0
None
Name [1] 381 0
None
Address [1] 381 0
Country [1] 381 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1448 0
The University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 1448 0
Ethics committee country [1] 1448 0
Australia
Date submitted for ethics approval [1] 1448 0
Approval date [1] 1448 0
31/12/2005
Ethics approval number [1] 1448 0
H-132-2004
Ethics committee name [2] 1449 0
The Royal College of General Practitioners National Research and Evaluation Ethics Committee
Ethics committee address [2] 1449 0
Ethics committee country [2] 1449 0
Australia
Date submitted for ethics approval [2] 1449 0
Approval date [2] 1449 0
07/02/2005
Ethics approval number [2] 1449 0
NREEC 05-01
Ethics committee name [3] 1450 0
The Departmental Ethics Committee of the Australian Government Department of Health and Ageing
Ethics committee address [3] 1450 0
Ethics committee country [3] 1450 0
Australia
Date submitted for ethics approval [3] 1450 0
Approval date [3] 1450 0
28/05/2004
Ethics approval number [3] 1450 0
3/2004
Ethics committee name [4] 1451 0
The Monash University Standing Committee on Ethics in Research Involving Humans.
Ethics committee address [4] 1451 0
Ethics committee country [4] 1451 0
Australia
Date submitted for ethics approval [4] 1451 0
Approval date [4] 1451 0
Ethics approval number [4] 1451 0
Ethics committee name [5] 1452 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [5] 1452 0
Ethics committee country [5] 1452 0
Australia
Date submitted for ethics approval [5] 1452 0
Approval date [5] 1452 0
Ethics approval number [5] 1452 0

Summary
Brief summary
The University of Adelaide, with funding from the Australian Government, Department of Health and Ageing (DoHA) is currently conducting a large research Trial investigating and evaluating the clinical effectiveness, cost effectiveness and safety of point of care testing (PoCT) in general practice. The Trial is of considerable national significance. In 2002, DoHA commissioned a review for the Medical Services Advisory Committee (MSAC) on the role and value of point of care testing in Australia. This report highlighted the potential advantages of PoCT, particularly in rural and remote practices, but concluded that further evidence needed to be collected concerning the clinical and economic benefits as well as the analytical performance of PoCT in the community setting.

The Point of Care Testing Trial will occur in three settings: urban, rural and remote. It will aim to demonstrate whether or not local pathology testing will improve and create more efficient care and be acceptable to both general practitioners (GPs) and their patients. It will also test whether these innovative models can be sustainable and safely implemented in general practice.

Approximately 6,000 patients of 60 general practices will participate in this Trial. Patients from half the practices will participate fully in the Trial and have their pathology tests conducted at the GP`s surgery; these will be known as the intervention group, while the other half will act as the control group and have their pathology testing done by the usual pathology group selected by their surgery.

Patients eligible to participate in the Trial are those 18 years and over and who have established diabetes, cardiovascular disease or who are taking anticoagulant medicine such as Warfarin.

There will be four tests used for the Trial. These four tests are:

Haemoglobin A1c (HbA1c): a blood test for monitoring the control of diabetes in patients with established diabetes.

Urine Albumin:Creatinine ratio (ACR): a urine test for detecting and, in this Trial, monitoring microalbuminuria (early renal disease) in patients with established diabetes.

Lipids: a blood test that measures different blood fats (total cholesterol [TC], high density lipoprotein [HDL] cholesterol, and triglyceride [TGL] in patients in this Trial who have hyperlipidaemia and who are taking lipid lowering drugs.

International Normalised Ratio (INR): a blood test that measures clotting time in patients receiving oral anticoagulant therapy (such as Warfarin).

Three different testing devices will be used in this Trial. These are the DCA 2000 (HbA1c and urine ACR [micralbuminuria]); the Cholestech LDX (blood lipids); and the CoagChek S (INR). All devices and consumables will be supplied to practices for the life of the Trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35335 0
Address 35335 0
Country 35335 0
Phone 35335 0
Fax 35335 0
Email 35335 0
Contact person for public queries
Name 9419 0
Ms Briony Glastonbury
Address 9419 0
PoCT Trial Manager
Department of General Practice
University of Adelaide
North Terrace SA 5005
Country 9419 0
Australia
Phone 9419 0
+61 8 83033535
Fax 9419 0
+61 8 83036271
Email 9419 0
briony.glastonbury@adelaide.edu.au
Contact person for scientific queries
Name 347 0
Ms Caroline Laurence
Address 347 0
Evaluation Manager
Department of General Practice
University of Adelaide
North Terrace SA 5005
Country 347 0
Australia
Phone 347 0
+61 8 83034951
Fax 347 0
+61 8 83036271
Email 347 0
caroline.laurence@adelaide.edu.au