Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000334303
Ethics application status
Not yet submitted
Date submitted
7/07/2008
Date registered
16/07/2008
Date last updated
3/07/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The Role Of Community Pharmacy in Post Hospital Management of Patients Initiated on Warfarin
Scientific title
The Development of a post hospital discharge pathway for adults taking warfarin which will result in an improved model of care compared to the current process.
Universal Trial Number (UTN)
Trial acronym
RFT-04
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication misadventure reduction in patients discharged from hospital after being commenced on warfarin or whose warfarin treatment was disrupted due to hospitalisation. 3369 0
Condition category
Condition code
Blood 3521 3521 0 0
Haematological diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A proposed best practice discharge pathway for patients either initiated on warfarin in hospital or whose treatment with warfarin was disrupted due to hospitalisation.
Currently, the usual management of patients taking warfarin who are discharged from hospital into the community involves providing the patient with a medication discharge sheet and notifying the general practitioner (GP) of the patient's condition requiring warfarin, their warfarin dose, their International Normalised Ratio (INR) at discharge and recommended dosage regimen for warfarin for that patient. Patient's routinely have follow-up pathology tests organised by their GP to monitor their INR levels and these are normally more frequent to begin with but taper to a once monthly pathology check once the patient's INR has stabilised. Unfortunately incomplete or misdirected information together with patient misunderstanding have resulted in inadequate or incorrect patient care. Often community pharmacies are overlooked in the discharge process.
This study will include, in addition to this usual care, a home follow-up medication review by an accredited pharmacist with an emphasis on patient warfarin education. Additionally a trained accredited pharmacist will take up to three measurements of the INR, two or three days apart, using a portable monitor. This will occur within the first 10 days of the patient's discharge. Feed back to the patient's GP will be provided in each instance. A final visit 90 days after discharge will be used to assess outcomes. Thirty suitable and consenting patients will then be trained to use a point of care monitor to measure their INR in the home. Result obtained will be sent to their GP on a weekly basis over 90 days for his consideration.
Intervention code [1] 3099 0
Treatment: Devices
Intervention code [2] 3100 0
Prevention
Comparator / control treatment
The control group will be adult patients initiated on warfarin or whose warfarin treatment was disrupted due to hospital admission and will receive, in addition to the usual care discharge pathway, one visit from a research pharmacist at day 8 post discharge when the INR will be measured. Any issues the pharmacist may discover at this time will be discussed with the patient's GP. This group will also be assessed at 90 days post discharge.
Control group
Active

Outcomes
Primary outcome [1] 4421 0
The development of a model supporting the role of the pharmacy profession in improving the transition between hospital and community-based care for patients taking warfarin. The evaluation which will be used to inform the development of this model will include process indicators and clinical outcomes from the study such as INR control and bleeding events in addition to participant satisfaction, determined by a questionnaire and the reconciliation of qualitative interviews and focus group sessions with key stakeholders.
Timepoint [1] 4421 0
90 days after discharge
Secondary outcome [1] 7548 0
To demonstrate that the proposed Patient Self Monitoring (PSM) model is feasible and that patients, their general practitioners and pharmacists are satisfied with this model of care. Clinical outcomes, such as the time of the INR in therapeutic range (TTR), and participant and stakeholder feedback (GP's and community pharmacists) via questionnaires will inform this part of the study. Issues raised will allow the refinement of the PSM phase of this trial.
Timepoint [1] 7548 0
180 days after discharge

Eligibility
Key inclusion criteria
Minimum age :18years
Maximum age: no limit
Gender: both males and females
Health: must have had their warfarin treatment disrupted due to hospitalisation or have been initiated on warfarin.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Language; Non English speaking
Other studies: Participation in a concurrent other study.
Demographics; not-home based on discharge or no GP
Dementia.

Study design
Purpose of the study
Prevention
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
Parallel
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
1/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 941 0
7000
Recruitment postcode(s) [2] 942 0
5000
Recruitment postcode(s) [3] 943 0
5042
Recruitment postcode(s) [4] 944 0
5600
Recruitment postcode(s) [5] 945 0
2139
Recruitment postcode(s) [6] 946 0
2065
Recruitment postcode(s) [7] 947 0
2500
Recruitment postcode(s) [8] 948 0
7320

Funding & Sponsors
Funding source category [1] 3554 0
Government body
Name [1] 3554 0
Department of Health and Ageing via the Fourth Community Pharmacy Agreement Research and Development Program
Country [1] 3554 0
Australia
Primary sponsor type
University
Name
The Unit for Medication Outcomes Research and Education, University of Tasmania
Address
Unit for Medication Outcomes Research and Education,
Tasmanian School of Pharmacy
University of Tasmania
105 Churchill Ave
Sandy Bay 7005
Country
Australia
Secondary sponsor category [1] 3193 0
University
Name [1] 3193 0
Faculty of Pharmacy, University of Sydney
Address [1] 3193 0
Faculty of Pharmacy,
University of Sydney,
NSW 2006
Country [1] 3193 0
Australia
Other collaborator category [1] 326 0
University
Name [1] 326 0
University of Wollongong
Address [1] 326 0
University of Wollongong
Wollongong
NSW 2522
Country [1] 326 0
Australia
Other collaborator category [2] 327 0
University
Name [2] 327 0
University of South Australia
Address [2] 327 0
School of Pharmacy and Medical Sciences
University of South Australia
Adelaide 5839
Country [2] 327 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 5597 0
Ethics committee address [1] 5597 0
Ethics committee country [1] 5597 0
Date submitted for ethics approval [1] 5597 0
09/06/2008
Approval date [1] 5597 0
Ethics approval number [1] 5597 0
EC00337

Summary
Brief summary
Warfarin is a difficult drug to manage safely especially when commenced. The Australian population is ageing and the use of warfarin particularly in the elderly as a treatment for stroke prevention is increasing. Furthermore changing treatment trends have resulted in shorter hospital stays which has increased the risk for warfarin patients who are being discharged before achieving a stable and effective warfarin level. This study will compare a control group following the usual care post discharge pathway with an intervention group receiving the proposed best practice discharge pathway. This will include a home medication review from an accredited pharmacist and follow-up checking of the INR of patients using a portable monitor within their home. Result will be referred to the patient's GP for evaluation. Outcomes such as bleeding and clotting events as well as unplanned hospital re-admission will be compared between the two groups. A small group of thirty of the intervention patients will, if consenting and able, be trained to perform self monitoring of the INR in their homes. The results obtained will be forwarded to their GP on a weekly basis for evaluation and possible warfarin dosage adjustment.
Trial website
www.anticoagulation.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28728 0
Address 28728 0
Country 28728 0
Phone 28728 0
Fax 28728 0
Email 28728 0
Contact person for public queries
Name 11885 0
Geoff Hill
Address 11885 0
UMORE
The School of Pharmacy
University of Tasmania
Private Bag 83
Hobart 7001
Country 11885 0
Australia
Phone 11885 0
03 62261024
Fax 11885 0
03 62267627
Email 11885 0
geoffh@utas.edu.au
Contact person for scientific queries
Name 2813 0
Gregory Peterson
Address 2813 0
UMORE
The School of Pharmacy
University of Tasmania
Private Bag 83
Hobart 7001
Country 2813 0
Australia
Phone 2813 0
03 62262197
Fax 2813 0
03 62267627
Email 2813 0
G.Peterson@utas.edu.au

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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