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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluation of patients’ warfarin knowledge and outcomes following secondary warfarin education (in an outpatient setting) compared with standard inpatient education, as measured by the Oral Anticoagulation Knowledge test.
Scientific title
In patients newly commenced on warfarin for any indication, does additional outpatient education compared to standard inpatient education improve patients' knowledge of warfarin and anticoagulation control, as measured by the Oral Anticoagulation Knowledge (OAK) test and International Normalised Ratio (INR) control.
Secondary ID [1] 286591 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anticoagulation control - Warfarin education 294885 0
Condition category
Condition code
Public Health 295129 295129 0 0
Health promotion/education
Cardiovascular 295182 295182 0 0
Diseases of the vasculature and circulation including the lymphatic system

Study type
Description of intervention(s) / exposure
Patients receive a 1 hour education session delivered by the primary researchers, as an outpatient. This includes a powerpoint presentation and a worksheet covering the basics of warfarin - how it works, indications, its purpose, practicalities for taking warfarin and testing INR, frequency of INR testing, interactions with drugs and diet, and major side of effects of warfarin (including when to seek help). The session occurs within 2 weeks of the patient leaving hospital.
Intervention code [1] 291708 0
Treatment: Other
Comparator / control treatment
Patients receive standard inpatient warfarin education, which is usually delivered by a ward pharmacist and normally takes 15-20 minutes. This involves the basics of warfarin including why the patient is on warfarin, checking their INR, dietary interactions and when to seek help.
Control group

Primary outcome [1] 294893 0
Oral Anticoagulation Knowledge (OAK) Test, a validated 20 question multiple choice test for assessing patients' knowledge of warfarin.
Timepoint [1] 294893 0
Administered 6 weeks post discharge from hospital
Secondary outcome [1] 314293 0
Patients' International Normalised Ratio (INR) control, as measured by Time in Therapeutic Range.
Timepoint [1] 314293 0
INR data was gathered from the time of discharge up to 2 months post discharge from hospital.

Key inclusion criteria
1. Newly commenced on warfarin (any indication)
2. Inpatient at Royal Melbourne Hospital
3. Age greater than or equal to 18 years old
Minimum age
18 Years
Maximum age
No limit
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
1. Duration of warfarin therapy <6 weeks
2. Non English speaking background with no available family translator
3. Prior warfarin therapy
4. Pregnancy
5. Moderate to severe cognitive impairment, defined as an Abbreviated Mental Test Score (AMTS) of 6 or less
6. Discharged to residential or nursing care, as warfarin was unlikely to be self-managed
7. Health professionals with prior knowledge of warfarin

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation schedule is generated in code (in SPSS, by a third party) prior to recruitment and held by a blinded third party. Allocation involves contacting the holder of the randomisation schedule who is “off-site”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people analysing the results/data
Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 3729 0
Royal Melbourne Hospital - City campus - Parkville

Funding & Sponsors
Funding source category [1] 291156 0
Self funded/Unfunded
Name [1] 291156 0
Shireen Bhatt
Address [1] 291156 0
9 Mercantile Parade,
VIC 3031
Country [1] 291156 0
Funding source category [2] 291157 0
Self funded/Unfunded
Name [2] 291157 0
Claire McCurdy
Address [2] 291157 0
19/8-10 Martin St
VIC 3071
Country [2] 291157 0
Primary sponsor type
Royal Melbourne Hospital
300 Grattan Street
VIC 3050
Secondary sponsor category [1] 289834 0
Name [1] 289834 0
The University of Melbourne
Address [1] 289834 0
VIC 3010
Country [1] 289834 0

Ethics approval
Ethics application status
Ethics committee name [1] 292733 0
Melbourne Health's Human Research Ethics Committee
Ethics committee address [1] 292733 0
300 Grattan Street,
Parkville 3050
Ethics committee country [1] 292733 0
Date submitted for ethics approval [1] 292733 0
Approval date [1] 292733 0
Ethics approval number [1] 292733 0

Brief summary
This study aims to examine the impact of extra education on patients' warfarin knowledge and anticoagulation control.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above who has been admitted to the Royal Melbourne Hospital and newly commenced on warfarin.

Study details
Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive the standard hospital warfarin education, delivered by pharmacists. Participants in the other group, in addition to the hospital education, will receive an extra hour of warfarin education once they have left hospital. This will be delivered by the primary investigators.

All participants will be asked to complete a 20 question multiple choice test to assess their knowledge of warfarin 6 weeks after they have left hospital.

We also ask participants for permission to collect their INR data to check their warfarin control.

It is hoped that this project will provide guidance as to whether we need to do more to educate patients about their warfarin therapy, or whether the education system we have in place currently is sufficient.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 56778 0
Dr Shireen Bhatt
Address 56778 0
Department of General Medicine
The Royal Melbourne Hospital
300 Grattan Street
VIC 3050
Country 56778 0
Phone 56778 0
Fax 56778 0
Email 56778 0
Contact person for public queries
Name 56779 0
Dr Shireen Bhatt
Address 56779 0
Department of General Medicine
The Royal Melbourne Hospital
300 Grattan Street
VIC 3050
Country 56779 0
Phone 56779 0
Fax 56779 0
Email 56779 0
Contact person for scientific queries
Name 56780 0
Dr Claire McCurdy
Address 56780 0
Department of General Medicine
The Royal Melbourne Hospital
300 Grattan Street
VIC 3050
Country 56780 0
Phone 56780 0
Fax 56780 0
Email 56780 0

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