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Trial registered on ANZCTR

Registration number

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

Hyperlipidaemia and anticoagulantm therapy

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Diet and Nutrition

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]

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]

improved control for patients with lipids, diabetes and INR

Timepoint [1]

At 18 months

Secondary outcome [1]

1) safety (competency, quality asurance, quality control and precision and accuracy)

Timepoint [1]

6 months

Secondary outcome [2]

2) Cost effectiveness of PoCT

Timepoint [2]

18 months

Secondary outcome [3]

3) Satisfaction with PoCT (GPs, patients, practice staff, other stakeholders).

Timepoint [3]

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

Sex

Both males and females

Can healthy volunteers participate?

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

1/09/2005

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

6836

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Department of Health and Ageing

Address [1]

Country [1]

Australia

Primary sponsor type

University

Name

Department of General Practice, The University of Adelaide

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Adelaide Human Research Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

31/12/2005

Ethics approval number [1]

H-132-2004

Ethics committee name [2]

The Royal College of General Practitioners National Research and Evaluation Ethics Committee

Ethics committee address [2]

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

07/02/2005

Ethics approval number [2]

NREEC 05-01

Ethics committee name [3]

The Departmental Ethics Committee of the Australian Government Department of Health and Ageing

Ethics committee address [3]

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

28/05/2004

Ethics approval number [3]

3/2004

Ethics committee name [4]

The Monash University Standing Committee on Ethics in Research Involving Humans.

Ethics committee address [4]

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

Approval date [4]

Ethics approval number [4]

Ethics committee name [5]

The University of Sydney Human Research Ethics Committee

Ethics committee address [5]

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

Approval date [5]

Ethics approval number [5]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Ms Briony Glastonbury

Address

PoCT Trial Manager
Department of General Practice
University of Adelaide
North Terrace SA 5005

Country

Australia

Phone

+61 8 83033535

Fax

+61 8 83036271

[email protected]

Contact person for scientific queries

Name

Ms Caroline Laurence

Address

Evaluation Manager
Department of General Practice
University of Adelaide
North Terrace SA 5005

Country

Australia

Phone

+61 8 83034951

Fax

+61 8 83036271

[email protected]

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	Citations or Other Details
Study results article	Yes	Tirimacco T, Glastonbury B, Laurence CO, Bubner TK... [More Details]
Study results article	Yes	Yelland LN, Salter AB, Ryan P, Laurence CO. Adjust... [More Details]
Study results article	Yes	Laurence CO, Moss JR, Briggs NE, Beilby JJ. The co... [More Details]
Study results article	Yes	Laurence CO, Gialamas A, Bubner T, Yelland L, Will... [More Details]
Study results article	Yes	Gialamas A; St John A; Laurence C; Bubner T, PoCT,... [More Details]
Study results article	Yes	Yelland L, Gialamas A, Laurence COM, Willson K, Ry... [More Details]
Study results article	Yes	Gialamas A, Laurence CO, Yelland LN, Tideman P, Wo... [More Details]
Study results article	Yes	Gialamas A, Yelland L, Ryan P, Willson K, Laurence... [More Details]
Study results article	Yes	Shephard MD, Mazzachi B, Watkinson L, Shephard A, ... [More Details]
Study results article	Yes	Shephard MD, Shephard A, Watkinson L, Mazzachi B, ... [More Details]
Study results article	Yes	Bubner T, Laurence COM, Gialamas A, Yelland L, Rya... [More Details]
Study results article	Yes	Laurence COM, Gialamas A, Yelland L, Bubner T, Rya... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Does point-of-care testing lead to the same or better adherence to medication? A randomised controlled trial: The PoCT in general practice trial.	2009	https://dx.doi.org/10.5694/j.1326-5377.2009.tb02910.x

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically