Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000374369
Ethics application status
Approved
Date submitted
17/07/2008
Date registered
31/07/2008
Date last updated
31/07/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
Pharmacy-Based Model Enabling Patient Self-Monitoring of Warfarin: Development and Evaluation
Scientific title
Providing community based patients taking warfarin with a clinical pathway to facilitate their transition from the current method of warfarin management to patient self-monitoring of the International Normalised Ratio.
Secondary ID [1] 651 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
In Australia there is currently no pathway to enable consumers taking warfarin who are suitable to perform patient self-monitoring (PSM) of the International Normalised Ratio (INR) to be trained and provided with on-going support. 3371 0
Condition category
Condition code
Blood 3523 3523 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
International research has established that patient self-monitoring (PSM) represents the gold standard for warfarin management. However PSM is not well established in Australia. This project aims to develop and implement a program to enable Australians taking warfarin to be provided with the necessary training and support to perform PSM.
A total of 30 patients will be involved in this trial, which will be conducted in NSW and Tasmania. Selected community pharmacies will identify participants according to a set of criteria which includes a willingness of the consumer to participate, a previous history of warfarin usage of at least 6 months and consent of the consumer's general practitioner (GP). Participants will be supplied with comprehensive education on warfarin and their disease state by a trained accredited pharmacist who will provide an education session with the aid of a warfarin manual developed by the project team. This manual and additional warfarin educational material, also developed by the project team, will be given to consumers for later reference. A pre-validated warfarin questionnaire will be used to assess the consumer's warfarin knowledge. They will then be trained to use a point of care (POC) device, which measures the International Normalised Ratio (INR), by an accredited pharmacist and this will usually involve one 2 hour session within the consumer's home. The consumer must demonstrate proficiency with this device by providing two separate INR readings that are within 15% of a laboratory result taken on the same day. In each instance this will involve the consumer performing a test INR measurement, which takes about three minutes and involves placing a drop of capillary blood on a test strip in the POC device, followed on the same day by their GP taking a sample of their venous blood for pathology testing. Once they have been trained to perform PSM, consumers will use the POC unit to measure their INR. An INR measurement will be taken every 2 weeks and the result obtained will be supplied to their GP, for warfarin dosage adjustment, over a period of 6 months. In addition, if considered appropriate, GPs can direct their patients to provide more frequent INR results or to have pathology confirmation of results obtained using the POC device at any time during this study. Data on clinical outcomes such as minor and major bleeding will be collected as well as the percentage of time spent by participants in the target INR range. These results will be compared with outcomes obtained over a 6 month pre-trial period for participating consumers.
Intervention code [1] 3102 0
Treatment: Devices
Comparator / control treatment
The control group will be an historical comparison of the intervention group's previous warfarin management. Specifically percentage of time spend within the therapeutic INR range will be compared between pre-trial and trial data and used as a means of gauging the benefits provided by the education and training package.
Control group
Historical

Outcomes
Primary outcome [1] 4426 0
The implementation of a model to enable patient self monitoring of the INR in collaboration with consumers and other health professionals. The model will be informed and refined based on feedback, including a warfarin knowledge questionnaire and an evaluation of the study questionnaire from consumers and an evaluation of the study questionnaire from general practitioners and community pharmacists involved in this study along with clinical data obtained during the trial.
Timepoint [1] 4426 0
300 days from the commencement of this study on 01/09/2008
Secondary outcome [1] 7560 0
The development of a train-the-trainer package to enable pharmacists to train consumers in PSM. This outcome will be assessed and refined by feedback received from participating accredited pharmacists and by the level of competency achieved by consumers with PSM as well as by GP and consumer feedback regarding the training package provided by the accredited pharmacist.
Timepoint [1] 7560 0
300 days from the commencement of this study on 01/09/2008
Secondary outcome [2] 7572 0
The development of a train-the-consumer package for pharmacists to use to train consumers. The level of consumer competency in patient self-monitoring following training together with an assessment of their warfarin knowledge and satisfaction with the training package will be used to further refine the consumer training package.
Timepoint [2] 7572 0
300 days from the commencement of this study on 01/09/2008

Eligibility
Key inclusion criteria
Patients must be willing to participate
Patients must have a history of at least 6 months usage of warfarin
Patients must have a long term indication for warfarin use
Patients must have their GP's consent
Patients must have the dexterity to use the POC device or a competent carer capable of assisting
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Language: non English speaking
Dementia:
Participation in other concurrent trials:
Failure to complete training with the accredited pharmacist or to demonstrate the required competency in the use of the POC device

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 959 0
7005
Recruitment postcode(s) [2] 960 0
7109
Recruitment postcode(s) [3] 961 0
7008
Recruitment postcode(s) [4] 962 0
7140
Recruitment postcode(s) [5] 989 0
7010
Recruitment postcode(s) [6] 990 0
7015
Recruitment postcode(s) [7] 991 0
7173
Recruitment postcode(s) [8] 992 0
7021
Recruitment postcode(s) [9] 993 0
7249
Recruitment postcode(s) [10] 994 0
7025
Recruitment postcode(s) [11] 995 0
2810
Recruitment postcode(s) [12] 1005 0
2830
Recruitment postcode(s) [13] 1006 0
2380
Recruitment postcode(s) [14] 1007 0
2229
Recruitment postcode(s) [15] 1008 0
2529
Recruitment postcode(s) [16] 1009 0
2340
Recruitment postcode(s) [17] 1010 0
2450
Recruitment postcode(s) [18] 1011 0
2445
Recruitment postcode(s) [19] 1012 0
2110

Funding & Sponsors
Funding source category [1] 3556 0
Government body
Name [1] 3556 0
Department of Health and Ageing as part of the Fourth Community Pharmacy Agreement
Country [1] 3556 0
Australia
Primary sponsor type
University
Name
Unit for Medication Outcomes Research and Education
Address
The School of Pharmacy
University of Tasmania
105 Churchill Ave
Sandy Bay
Tas 7005
Country
Australia
Secondary sponsor category [1] 3194 0
University
Name [1] 3194 0
Faculty of Pharmacy
Address [1] 3194 0
The Faculty of Pharmacy
University of Sydney
NSW 2006
Country [1] 3194 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5700 0
Tasmanian Health & Medical Human Research Ethics Committee (EC00337)
Ethics committee address [1] 5700 0
Ethics committee country [1] 5700 0
Australia
Date submitted for ethics approval [1] 5700 0
Approval date [1] 5700 0
29/01/2008
Ethics approval number [1] 5700 0
H9825

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28730 0
Address 28730 0
Country 28730 0
Phone 28730 0
Fax 28730 0
Email 28730 0
Contact person for public queries
Name 11887 0
Geoff Hill
Address 11887 0
UMORE
The School of Pharmacy
The University of Tasmania
Private Bag 83
Hobart
Tas 7001
Country 11887 0
Australia
Phone 11887 0
03 62261024
Fax 11887 0
03 62267627
Email 11887 0
[email protected]
Contact person for scientific queries
Name 2815 0
Luke Bereznicki
Address 2815 0
UMORE
The School of Pharmacy
The University of Tasmania
Private Bag 83
Hobart
Tas 7001
Country 2815 0
Australia
Phone 2815 0
03 62262195
Fax 2815 0
03 62267627
Email 2815 0
[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
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