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Trial registered on ANZCTR


Registration number
ACTRN12613000060741
Ethics application status
Approved
Date submitted
16/01/2013
Date registered
16/01/2013
Date last updated
16/01/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising Stroke Prevention in Older People with Atrial Fibrillation.
Scientific title
The increasing burden of stroke with ageing: Using a computerised antithrombotic risk assessment tool to optimise preventative treatment in the community.
Secondary ID [1] 281785 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Computerised Antithrombotic Risk Assessment Tool (CARAT) Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 288106 0
Atrial Fibrillation 288107 0
Condition category
Condition code
Blood 288480 288480 0 0
Clotting disorders
Cardiovascular 288481 288481 0 0
Other cardiovascular diseases
Stroke 288482 288482 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
General Practitioners (GPs) in the intervention arm will utilise an online computerised antithrombotic risk assessment tool (CARAT) during routine clinical practice to support their decision-making processes in selecting and/or reviewing antithrombotic (anti-clotting) therapy in their elderly patients with atrial fibrillation. Administration of CARAT will take 15-20 minutes. The intervention will be trialled by GPs over 12 months. CARAT will be applied at 0 and 12 months, and involves a combination of questions that assess stroke risk, bleeding risk and medication safety issues. CARAT will then quantify the patient’s estimated risk of stroke versus bleeding, flag pertinent medication management issues, and generate a recommendation for therapy (warfarin, aspirin, none, other).The GP will consider the CARAT output and make a final treatment decision to initiate, cease, or maintain current therapy. Where the GP may disagree with CARAT, the rationale for the decision will be documented in the data collection process. Reviewed patients will be followed-up for up to 12 months (0, 1, 6, 12 months) to document key clinical outcomes (i.e., strokes, bleeds).
Intervention code [1] 286328 0
Prevention
Comparator / control treatment
GPs in the control arm will follow their usual care practices, i.e., they will review and select antithrombotic therapy using their own clinical judgement, processes and resources.
Control group
Active

Outcomes
Primary outcome [1] 288640 0
changes to antithrombotic therapy (initiations, changes, cessations) made by GPs following application of CARAT.
Timepoint [1] 288640 0
0, 1, 6, 12 months
Primary outcome [2] 288641 0
difference in the proportion of patients receiving antithrombotic therapy and those receiving no therapy at all.
Timepoint [2] 288641 0
0, 1, 6, 12 months
Primary outcome [3] 288642 0
difference in the proportion of patients experiencing adverse clinical outcomes (ALL events).
Timepoint [3] 288642 0
0, 1, 6, 12 months
Secondary outcome [1] 300681 0
the sustainability of prescribed therapy over time, i.e., changes to antithrombotic therapy made during patient follow-up over 12 months.
Timepoint [1] 300681 0
0, 1, 6, 12 months
Secondary outcome [2] 300682 0
incidence of any clotting (thromboembolism, stroke) and bleeding (minor or major haemorrhage) events over 12 months.
Timepoint [2] 300682 0
0,1, 6, 12 months
Secondary outcome [3] 300683 0
Health related quality of life (using SF-36 Health Survey).
Timepoint [3] 300683 0
0, 12 months

Eligibility
Key inclusion criteria
GPs:
1. must be practicing in one site (i.e., general practice surgery), not across multiple sites or surgeries
2. must practice in the specified Divisions of General Practice
3. must provide informed written consent to participate in the study

Patients:
1. aged >= 65 years (older persons)
2. have a diagnosis of chronic (persistent) AF, whether new or pre-existing, irrespective of the antithrombotic therapy prescribed at the time of recruitment
3. provide informed written consent to participate in the study, including telephone follow-up
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
GPs:
1. not practicing in one site (i.e., general practice surgery across multiple sites or surgeries)
2. not practicing in the specified Divisions of General Practice
3. do not provide informed written consent to participate in the study

Patients:
1. aged < 65 years
2. do not have a diagnosis of chronic (persistent) AF
3. do not provide informed written consent to participate in the study, including telephone follow-up

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
GPs will be recruited via invitational letters, flyers inside newsletters, and presentations during education events, coordinated by the Divisions of General Practice. Patients will be recruited by their GPs during routine care (consecutive consults over 3 months). Participants will be required to provide informed written consent.
Randomisation will be coordinated centrally by a Chief Investigator independent of GP recruitment, intervention implementation, or data collection, and who will conceal the initial allocation process from Research Assistants (e.g., allocation numbers will be placed in sealed, serially coded envelopes, and housed in a locked cabinet in Chief Investigators office).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once recruited, GPs will be randomly allocated to a study arm using computer-generated random allocation number sequences.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Computerised data analysis will employ SPSS (Statistical Package for the Social Sciences). ANOVA will test for differences in continuous variables. The Chi-square test will examine differences in independent proportions. Kappa analysis will detect the level of agreement between prescribers’ clinical judgement and the CARAT output. Logistic regression analysis will identify predictors of clinical events (clotting versus bleeding), and selection of antithrombotic therapy, accounting for the use of the CARAT. Survival analysis will assess mortality rates in both arms. All analyses will be adjusted for the effects of clustering, and set at a significance (p) level of 0.05.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 286568 0
Government body
Name [1] 286568 0
National Health and Medical Research Council
Address [1] 286568 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Postal Address:
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 286568 0
Australia
Primary sponsor type
University
Name
University of Technology, Sydney
Address
City campus
15 Broadway,
Ultimo, NSW 2007

Postal Address:
University of Technology, Sydney
P.O. Box 123
Broadway, NSW 2007
Australia
Country
Australia
Secondary sponsor category [1] 285354 0
University
Name [1] 285354 0
University of Sydney
Address [1] 285354 0
The University of Sydney
NSW 2006
Australia
Country [1] 285354 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288634 0
Human Research Ethics Committee
Ethics committee address [1] 288634 0
Research Integrity
Level 6
Jane Foss Russell Building G02
University of Sydney NSW 2006


Ethics committee country [1] 288634 0
Australia
Date submitted for ethics approval [1] 288634 0
Approval date [1] 288634 0
22/02/2010
Ethics approval number [1] 288634 0
12453
Ethics committee name [2] 288635 0
Human Research Ethics Committee
Ethics committee address [2] 288635 0
University of Technology, Sydney
Level 14,
Building 1,
15 Broadway,
Ultimo, NSW 2007

Ethics committee country [2] 288635 0
Australia
Date submitted for ethics approval [2] 288635 0
Approval date [2] 288635 0
22/02/2010
Ethics approval number [2] 288635 0
2011-348R

Summary
Brief summary
The burden of stroke due to atrial fibrillation (AF; a common irregular heart rhythm) is high, especially in older persons in whom AF is most common. To prevent stroke in this high-risk population antithrombotic (anti-clotting) medicines must be used. Warfarin is currently the recommended therapy, however, it requires careful monitoring & management to avoid side-effects (eg bleeding), leading some clinicians to choose less effective therapies (aspirin) for their patients. This clinical trial will test the use of a novel computerised clinical tool (CARAT) to assist GPs in assessing their patients risk of stroke versus side-effects from treatment, and recommended treatment based on ‘risk assessment’.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37086 0
A/Prof Beata Bajorek
Address 37086 0
University of Technology, Sydney
School of Pharmacy
CB01.13.31

P.O. Box 123
Broadway, NSW 2007
Country 37086 0
Australia
Phone 37086 0
+61-2-9514-8301
Fax 37086 0
Email 37086 0
Beata.Bajorek@uts.edu.au
Contact person for public queries
Name 37087 0
A/Prof Beata Bajorek
Address 37087 0
University of Technology, Sydney
School of Pharmacy
CB01.13.31

P.O. Box 123
Broadway, NSW 2007
Country 37087 0
Australia
Phone 37087 0
+61-2-9514-8301
Fax 37087 0
Email 37087 0
Beata.Bajorek@uts.edu.au
Contact person for scientific queries
Name 37088 0
A/Prof Beata Bajorek
Address 37088 0
University of Technology, Sydney
School of Pharmacy
CB01.13.31

P.O. Box 123
Broadway, NSW 2007
Country 37088 0
Australia
Phone 37088 0
+61-2-9514-8301
Fax 37088 0
Email 37088 0
Beata.Bajorek@uts.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary