None listed
Conditions
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.
Interventions
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.
Sponsors
Department of General Practice, The University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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).
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.
Outcome results
None listed