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ISRCTN
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ISRCTN76463647
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ClinicalTrials.gov identifier
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Public title
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Optimising thromboembolic and stroke prevention in pharmacist-managed oral anticoagulotherapy
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Scientific title
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Optimising thromboembolic and stroke prevention: a randomised controlled trial of pharmacist-managed oral anticoagulotherapy
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Acronym
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PHARMA
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Serial number at source
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UCT-58955
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Study hypothesis
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Compared to the centralised care model, the integrated care model may be associated with similar anticoagulation control, similar incidence of major haemorrhagic and thromboembolic events and similar patient’s quality of life. However, the integrated care may represent a more efficient use of the health-care system. It may be less costly.
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Lay summary
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Ethics approval
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Cité de la Santé de Laval, Comité d'éthique et de la recherche (conditional approval of the project: 18th December 2001). Full approval as on 12th November 2002 until 11th November 2003; amendments to the protocol made on 16th September 2003. Reapprobation of the project on the following dates:
18th November 2003: reapprobation of the project until 11th November 2004
9th October 2004: reapprobation of the project until 15th September 2005
11th October 2005: reapprobation of the project until 11th November 2006
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Study design
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Randomised controlled trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Thromboembolism and stroke
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Participants - inclusion criteria
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1. The patient is referred to the Pharmacy Managed Anticoagulation Service (PMAS) with a prescription of warfarin for at least six months
2. The patient is aged 18 years and older, either sex
3. The patient agrees to go to the Cité de la Santé de Laval, the Centre Hospitalier Ambulatoire Régional de Laval, or one of the four Laval Centre Local de Services Communautaire for blood drawing during participation in the study (six months)
4. The patient lives in the Laval area
5. The patient is able to read and speak French or English
6. The patient agrees to participate in the study and has signed the informed consent form
7. The patient's treating physician has agreed to participate and has signed the informed consent form
8. It is expected that the patient will be transferred to the treating physician
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Participants - exclusion criteria
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1. The patient participates to another study
2. The patient is referred to the PMAS for a pre-admission
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Anticipated start date
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01/01/2001
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Anticipated end date
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31/03/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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500
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Interventions
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A three-year randomised controlled trial (RCT) will be conducted. All patients registering at the PMAS with a first prescription of warfarin for a minimum of six months and who agree to participate (n = 500) will be randomised to the integrated or the centralised PMAS model of care.
Integrated care model: Patients will be monitored by PMAS pharmacists until stabilisation of their international normalised ratio (INR) within their prescribed therapeutic range (six to eight weeks). Thereafter, they will be transferred to their treating physician.
Centralised care model: Patients will be monitored by PMAS for the entire duration of the study.
All patients will be followed for a total of six months. We will monitor the quality of INR control, the incidence of major thromboembolic and haemorrhagic events, the patient’s health-related quality of life, and direct health-care costs associated with each model of care.
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Primary outcome measure(s)
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The percentage of time spent within the target INR range.
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Secondary outcome measure(s)
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1. Incidence and severity of major thromboembolic and haemorrhagic events
2. Health-related quality of life
3. Direct medical-care costs
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Sources of funding
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1. Canadian Institutes of Health Research (CIHR) (Canada) - http://www.cihr-irsc.gc.ca (ref: UCT-58955)
2. Taro Pharmaceutical Inc. (Canada)
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Trial website
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Publications
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2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18585510
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Contact name
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Dr
Lyne
Lalonde
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Address
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Équipe de recherche
Soins de première ligne
Centre de santé et de services sociaux de Laval (Cité de la Santé de Laval)
1755 René-Laennec
Local D-S145
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City/town
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Laval
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Zip/Postcode
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H7M 3L9
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Country
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Canada
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Tel
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+1 514 343 6111 ext. 5315
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Fax
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+1 514 343 5691
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Email
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lyne.lalonde@umontreal.ca
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Sponsor
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Cité de la Santé de Laval (Canada)
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Address
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University of Montreal
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City/town
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Laval
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Zip/Postcode
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H3C 3J7
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Country
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Canada
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Sponsor website:
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http://www.cssslaval.qc.ca/
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Date applied
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05/09/2005
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Last edited
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11/03/2009
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Date ISRCTN assigned
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05/09/2005
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