Point of Care Testing Trial Report - Executive Summary
I. Overview
Table of contents
The Point of Care Testing (PoCT) in General Practice Trial (the Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial (RCT), to investigate and evaluate the safety, clinical effectiveness cost effectiveness and satisfaction of PoCT in a general practice environment.
The Trial also sought to determine:
- if there were any differences between urban, rural and remote geographic regions in any of the parameters measured
- if the regulatory environment used for the Trial would meet the needs of all the stakeholders if PoCT were to be made more generally available
- what would be the appropriate Medical Benefits Schedule (MBS) fee for the tests selected in the Trial?
The Trial involved:
- an 18-month ‘live’ period from 1September 2005 to 28 February 2007
- a total of 58 practices over a large geographic area (urban, rural and remote areas in South Australia, New South Wales and Victoria)
- a broad range of 26 practices randomised to the control group and 32 practices randomised to the intervention group
- the participation of 247 General Practitioners (GPs)
- 5,234 patients recruited from the practices of which 944 patients were on anticoagulant therapy, 1,967 had established diabetes and 3,819 had established hyperlipidaemia
- the use of PoC for seven tests used in the management of patients with diabetes (HbA1c, urine albumin and albumin creatinine ratio), hyperlipidaemia (total cholesterol, high density lipoprotein (HDL-C) and triglycerides) and patients on anticoagulant therapy (INR)
- 80 practice staff trained as Device Operators – five were GPs and the rest other practice staff
- 23 pathology providers/laboratories representing 10 parent companies linked to the practices recruited for the Trial.
The aim of the PoCT Trial was to answer the primary research question ‘Should PoCT in general practice be implemented by the Australian Government (for patients with established diabetes, established hyperlipidaemia or on anticoagulant therapy).
The evaluation protocol and data collection processes took into account the large number of patients, the broad range of practice types distributed over a large geographic area, and the inclusion of pathology test results from multiple pathology laboratories. The evaluation protocol also reflected the complexity of the Trial setting, the Trial Design and the approach taken within the funding provided.
The PoCT Trial is regarded as a pragmatic RCT, evaluating the effectiveness of implementing PoCT in general practice. Every effort was made to ensure that, in these circumstances, internal and external validity was maintained.
