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Trial registered on ANZCTR


Registration number
ACTRN12615000429550
Ethics application status
Approved
Date submitted
24/04/2015
Date registered
6/05/2015
Date last updated
6/05/2015
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
Nil
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

Intervention/exposure
Study type
Interventional
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
Active

Outcomes
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.

Eligibility
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
VIC
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,
Kensington
VIC 3031
Country [1] 291156 0
Australia
Funding source category [2] 291157 0
Self funded/Unfunded
Name [2] 291157 0
Claire McCurdy
Address [2] 291157 0
19/8-10 Martin St
Thornbury
VIC 3071
Country [2] 291157 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
300 Grattan Street
Parkville
VIC 3050
Country
Australia
Secondary sponsor category [1] 289834 0
University
Name [1] 289834 0
The University of Melbourne
Address [1] 289834 0
Parkville
VIC 3010
Country [1] 289834 0
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 292733 0
15/10/2013
Approval date [1] 292733 0
28/10/2013
Ethics approval number [1] 292733 0
QA2013164

Summary
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

Contacts
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
Australia
Phone 56778 0
+61429854359
Fax 56778 0
Email 56778 0
sheen.bhatt@gmail.com
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
Australia
Phone 56779 0
+61429854359
Fax 56779 0
Email 56779 0
sheen.bhatt@gmail.com
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
Australia
Phone 56780 0
+61418322181
Fax 56780 0
Email 56780 0
claire.e.mccurdy@gmail.com

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