A correction for this article has been published in Trials 2009, 10:7

Study protocol

A pragmatic cluster randomised controlled trial to evaluate the safety, clinical effectiveness, cost effectiveness and satisfaction with point of care testing in a general practice setting – rationale, design and baseline characteristics

Caroline Laurence¹ , Angela Gialamas¹ , Lisa Yelland² , Tanya Bubner¹ , Philip Ryan² , Kristyn Willson² , Briony Glastonbury³ , Janice Gill⁴ , Mark Shephard⁵ and Justin Beilby⁶ for members of the PoCT Trial Management Committee

¹Discipline of General Practice, The University of Adelaide, Adelaide, South Australia, Australia

²Discipline of Public Health, The University of Adelaide, Adelaide, South Australia, Australia

³Save Sight Institute, University of Sydney, Sydney, New South Wales, Australia

⁴RCPA Quality Assurance Programs Pty Ltd, Adelaide, South Australia, Australia

⁵Community Point-of-Care Services, Flinders University Rural Clinical School, Flinders University, Adelaide, South Australia, Australia

⁶Faculty of Health Sciences, The University of Adelaide, Adelaide, South Australia, Australia

author email corresponding author email

Trials 2008, 9:50doi:10.1186/1745-6215-9-50

Published:	6 August 2008

Abstract

Background

Point of care testing (PoCT) may be a useful adjunct in the management of chronic conditions in general practice (GP). The provision of pathology test results at the time of the consultation could lead to enhanced clinical management, better health outcomes, greater convenience and satisfaction for patients and general practitioners (GPs), and savings in costs and time. It could also result in inappropriate testing, increased consultations and poor health outcomes resulting from inaccurate results. Currently there are very few randomised controlled trials (RCTs) in GP that have investigated these aspects of PoCT.

Design/Methods

The Point of Care Testing in General Practice Trial (PoCT Trial) was an Australian Government funded multi-centre, cluster randomised controlled trial to determine the safety, clinical effectiveness, cost effectiveness and satisfaction of PoCT in a GP setting.

The PoCT Trial covered an 18 month period with the intervention consisting of the use of PoCT for seven tests used in the management of patients with diabetes, hyperlipidaemia and patients on anticoagulant therapy. The primary outcome measure was the proportion of patients within target range, a measure of therapeutic control. In addition, the PoCT Trial investigated the safety of PoCT, impact of PoCT on patient compliance to medication, stakeholder satisfaction, cost effectiveness of PoCT versus laboratory testing, and influence of geographic location.

Discussion

The paper provides an overview of the Trial Design, the rationale for the research methodology chosen and how the Trial was implemented in a GP environment. 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 developed reflects 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 GP and every effort was made to ensure that, in these circumstances, internal and external validity was maintained.

Trial Registration

12612605000272695