Point of Care Testing Trial (PoCT) More Information

General information about the Point of Care Testing (PoCT) trial.

Page last updated: 20 March 2012

Final Report

The Executive Summary and final report of the trial are available at the following links:
Point of Care Testing in General Practice Trial Report - Executive Summary
Point of Care Testing in General Practice Trial Report - Full report (PDF)

For queries about PoCT, please email npaac@health.gov.au

What is Point of Care Testing (PoCT)?

Technological advances in the area of PoCT mean that there are a number of tests now available that can be used in a non-laboratory setting.

PoCT is pathology investigation by or on behalf of the treating medical practitioner in their surgery at the time of consultation allowing results to be used to make immediate, informed decisions about patient care. For the purposes of this trial it was defined as:

  • being conducted in a general practice setting at the time of consultation;
  • performed by the GP or a trained surgery staff member; and
  • the test result provided is used to inform treatment at the time of the consultation.

Why was there a trial?

The Pathology Services Table (PST) lists the pathology tests for which Medicare benefits are payable. Only a few tests, defined as simple and basic, can currently be performed in a non-laboratory environment and be rebated under the Medicare Benefits Schedule (MBS).

Top of page The Health Insurance Act 1973 allows the Minister for Health and Ageing to determine an appropriate Pathology Services Table which is then prescribed by Regulation.

A report to the Medical Services Advisory Committee (MSAC) in 2001 indicated that there is a lack of evidence around the clinical and economic benefits of PoCT. The report recommended that further information be collected on the diagnostic performance of PoCT in the community setting.

How large was the trial?

The trial covered urban, rural and remote regions with each region being supported by a lead Division of General Practice.

There were 58 practices and 247 General Practitioners participating in the trial. Each practice was randomly assigned to an experimental group or a control group.

The total number of patients who participated was over 5,000.

How long did the trial last?

The trial started in early 2005 with an initial six month preparation phase during which participants were recruited and the trial set up.

There were three phases during the live part of the trial, each of approximately six months duration. During the first phase patients in the experimental group had their testing performed by pathology laboratories and by PoCT. In the second and third phases, patients in the experimental group were generally tested using only PoCT while those in the control group continued to be tested by pathology laboratories.

The Trial Manager reported to the PoCT Steering Group on a regular basis, and particularly at the end of each phase, on the continuing safety and effectiveness of PoCT.

The live phase of the trial commenced on 1 September 2005 and ended on 28 February 2007. Extensive data analysis was then undertaken. The final report was released in March 2009.Top of page

How was it funded?

The trial was fully funded by the Australian Government. Practices were provided with the equipment and consumables required for PoCT and received payment through temporary arrangements on the MBS for each test conducted.

Practices with patients in the control group were funded for the time required to seek informed consent and to provide the data required for trial evaluation.

What are the advantages of PoCT?

Potential advantages of PoCT include:
  • enhanced clinical management;
  • greater patient compliance with pathology requests;
  • greater convenience and satisfaction for patients - speed of diagnosis and treatment decision with fewer visits to the doctor;
  • better health outcomes to the patient;
  • greater satisfaction for the GP;
  • savings in cost and time for patients because PoCT is done at the time of consultation; and
  • improvement in doctor/patient relationship.

And the disadvantages of PoCT?

Potential disadvantages of PoCT include:
  • inappropriate testing leading to increased costs with no benefits to the patient or to society;
  • inaccurate results which leads to less than optimal health outcomes for the patient with additional testing and treatment;
  • possible increased consultation and waiting time.

What were the research questions?

The primary research question was 'Should PoCT in General Practice be funded by the Australian Government'?

A number of secondary research questions were evaluated during the trial:

  • Is it safe to perform PoCT?
  • Is the effectiveness of PoCT at least as good as for the same tests using pathology laboratory testing?
  • Is it the same or more cost-effective to perform PoCT compared with pathology laboratory testing?
  • Are patients and other stakeholders more satisfied with PoCT than with pathology laboratory testing?
  • Are there differences between urban, rural and remote geographic regions in any of the parameters measured?
  • Would the regulatory environment used for the trial meet the needs of all the stakeholders if PoCT were to be made generally available?
  • What would the appropriate MBS fees be for the PoCT tests selected to be in the trial?Top of page

How were the tests chosen?

The pathology tests for the trial were chosen on the basis of:
  • minimising risk to patients;
  • recognising that cardiovascular disease and diabetes are National Health Priority Areas;
  • what would give the most likely positive outcome for the trial on the basis of prevalence of chronic conditions;
  • following recommendations from MSAC; and
  • previous reports commissioned by the Department of Health and Ageing and submissions to MSAC.

    How were practices chosen?

    The trial was supported in each of the geographical areas by three Divisions of General Practice and a trial Node Manager. The Divisions and Node Manager, in consultation with the Trial Manager, assessed expressions of interest from practices against the following criteria:
    • the practice had current accreditation under 2nd Edition RACGP Standards for General Practice;
    • the practice was not involved in other primary care pathology trials;
    • associated pathology practice agreement on provision of quality assurance reports;
    • the practice had a minimum patient load from all disease groups;
    • the practice had suitable facilities for PoCT;
    • the practice could demonstrate a commitment to the trial and its objectives;
    • there had been previous involvement in projects and/or in on-site pathology testing; and
    • the practice had a willingness to direct bill the PoCT items to Medicare.

    How were Divisions chosen?

    Divisions provided advice to the Node Managers and the Trial Manager. They were also involved in the selection of practices, the training workshops and trial governance.

    Divisions were asked to prepare an expression of interest to participate in the trial. The Divisions were required to prepare a two page document addressing each of the following criteria:

    • capacity to recruit 20 practices meeting the criteria or to lead a consortium of Divisions to achieve the same goal;
    • demonstrated project management experience;
    • existing infrastructure, including project coordinator and practice support capacity;
    • relative cost to the trial of each participating Division in their comparable geographic area; and
    • how typical the Division was of their geographic region.

    What was the role of pathology laboratories?

    GPs participating in the trial advised their Division and Node Manager which pathology laboratories they used. Their Division and Node Manager then contacted the pathology laboratory to ask them to participate in the trial.

    For the first six months of the trial patients in the experimental group had their tests undertaken by both PoCT and by a pathology laboratory. At the end of the six months the trial's Steering Group examined the analysis of the results to see if the PoCT results were valid and accurate when compared to the laboratory tests. The Steering Group then gave approval for patients to have PoCT testing only, although for a short period of time laboratory testing, in addition to PoCT testing, was undertaken for International Normalised Ratio (INR) tests.

    At any stage of the trial the patient or GP could have decided to opt out of the trial.

    The pathology laboratory provided data, such as relevant quality assurance reports and pathology reports, to the PoCT Trial Manager. Top of page

    Which patients were eligible?

    Initial diagnosis or population screening was not permitted during this trial. Patients from the selected general practices were eligible if they had a pre-existing diagnosis for:

    Anticoagulant therapy

    • The patient had been prescribed warfarin and had had International Normalised Ratio (INR) test results within the therapeutic range for at least one month.
    Hyperlipidaemia
    • The patient was, or had been, eligible for pharmaceutical benefits for lipid lowering drugs.
    Diabetes
    • The patient had a fasting plasma glucose greater than or equal to 7.0mmol/L or two hour post glucose load greater than or equal to 11.1mmol/L.

    Patients were recruited in the first three months of the trial. Patients chose to participate in the trial and could leave the trial at any time. Top of page

    What tests were performed?

    Anticoagulant therapy
    • INR - the result for the prothombin time was expressed as a ratio (clotting time for patient plasma divided by time for control plasma). A correction factor (International Sensitivity Index) was applied to the prothrombin ratio (as the sensitivity of commercial throboplastin reagents is variable) and the result issued as an INR.

    Hyperlipidaemia
    • Total Cholesterol (TC) - quantitation in blood, plasma or serum after a 12 hour fast;
    • High Density Lipoprotein (HDL) - quantitation in blood, plasma or serum after a 12 hour fast; and
    • Triglycerides (TG) - quantitation in blood, plasma or serum after a 12 hour fast.

    Diabetes
    • Glycosylated haemoglobin (HbA1c) - quantitation in blood of HbA1c; and
    • Microalbumin - quantitation as determined by urine albumin excretion on a timed overnight urine sample or urine albumin/creatinine ratio as determined on a first morning sample.

      What support was offered?

      The Trial Manager and node managers provided support to trial participants. The Trial Manager also provided educational and trial guidance materials.
    In conjunction with device suppliers, the node managers acted as trainers in the use of the PoCT devices and as mentors for the practice trial participants. They were also trained in all aspects of troubleshooting for the devices and the protocols of the trial.

    What were the reporting requirements?

    Practices and/or pathology laboratories, with the agreement of participating patient, GP and pathology laboratory sent to the Trial Manager:
    • copies of pathology reports and requests;
    • quality assurance reports and issues logs;
    • comparison of PoCT testing to laboratory testing;
    • costing data;
    • numbers of participating patients and the number and types of test performed; and
    • patients lost to follow-up.Top of page

    What about quality control?

    A Standards manual, titled Interim Standards for PoCT Testing in General Practice Incorporating PoCT Trial Guidelines, was developed to guide practices in maintaining quality assurance.

    Interim Standards for PoCT Testing in General Practice Incorporating PoCT Trial Guidelines (PDF 640 KB)

    Internal quality control was conducted by reference to this standard and to the device manufacturer's instruction. External quality assurance was conducted by the Royal College of Pathologists of Australasia Quality Assurance Programs Pty Limited.

    What were the accreditation requirements?

    Normal practice accreditation was a prerequisite of the trial. Practices also needed PoCT accreditation to be eligible to participate. This accreditation followed successful assessment of the practice by a surveyor against the Interim Standards for PoCT Testing in General Practice Incorporating PoCT Trial Guidelines.

    It was not necessary for practices to be accredited as a pathology provider as Medicare Item numbers for the nominated tests in a general practice were added to the PST for use by participants in the trial for its duration.

    Were surveys conducted?

    Yes, surveys were conducted for each of the groups participating in the trial.

    Practices were asked about a range of issues including their comments on training, equipment, health outcomes and convenience.

    Divisions were surveyed to obtain information about how the Divisions felt about the trial management, the coordination aspects of the trial, and what could be improved.

    Pathology laboratories were asked about their level of interaction with GPs, repeat and other testing, and what support they gave to GPs.

    Patients were surveyed during the trial to ascertain their compliance with disease management and medication instructions. Patients were also surveyed to determine the level of patients' confidence, satisfaction and convenience.

    Will a report be available to participants?

    Patients received a summary report based on group data.

    Other participants also received a report, based on aggregated data, containing more technical information.

    The final Executive Summary of the report has been published on the Department of Health and Ageing's web-site so all interested people have the opportunity to provide comment on it.Top of page

    Who were the members of the trial's Steering Group?

    Professor Paul Monagle represented the Australian Association of Pathology Practices, Royal College of Pathologists of Australasia and the National Coaliltion of Public Pathology.
    Mr Roger Killeen represented the Consumers Health Forum of Australia.
    The Dr Michael Harrison represented the Quality Use of Pathology Committee.
    The late Dr David Barton (medical adviser) and a Pathology Section director represented the Department of Health and Ageing.

    Who can I contact if I have questions?

    If you have any further questions regarding this topic, please contact the PoCT secretariat.
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