A Phase 4 interventional study of anticoagulation clinic care and usual care in Warfarin, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-06-24.
Sponsored by University of Alberta · Phase 4, Interventional, and Health services research
Warfarin is a medication typically referred to as a blood thinner and is used to prevent the formation of blood clots, and hence prevent life-threatening events such as strokes and clots on the lungs (known as pulmonary emboli). This therapy is only safe and effective if the degree of blood thinning is kept within a narrow window - if the blood is "too thick" clots may form but if the blood is "too thin" the risk of bleeding increases. Complicating the control of warfarin is that different people require different amounts of it to have an appropriate degree of blood thinning, and once this amount is determined for a patient, it may be changed by factors that are encountered on a daily basis (i.e., diet, acute and chronic diseases, alcohol, medications, etc.). As such, regular monitoring is necessary to confer the benefits of this medication. Our Anticoagulation Management Service (AMS) has demonstrated really good control of blood thinning therapy by working with patients to inform them of the rationale for this medicine, the factors having the ability to impact its control, and encouraging the patient to be involved in their care (via provision of tools to document test results, one-on-one education and access to our program at any time with questions, etc.) Currently, our AMS has to limit the volume of patients seen due to resource limitations. As such, it is imperative that we investigate alternate strategies to manage these patients. Paramount, however, is that any long-term strategy must not confer inferior control of warfarin. The purpose of this study is to determine if the impact of AMS Care is sustained following the transfer of anticoagulation management to the family doctor. Operationally, the results of this study will guide future management of patients. If control of warfarin therapy declines with family doctor management, alternate strategies, such as patient self-management, will need to be investigated in a larger scale trial.
University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient continues to receive anticoagulation care from the Anticoagulation Management Service
Other: anticoagulation clinic care
Patient receives anticoagulation care from their usual primary care physician
Other: usual care
Patient receives care from the outpatient anticoagulation management service
patient receives usual anticoagulation care from their regular primary care physician
Adequacy of anticoagulation control (proportion of time in the therapeutic anticoagulation range +/- 0.5 INR unit) by the Rosendaal method.
Time frame: 6 months
Time within expanded therapeutic range (+/- 0.7 INR unit) by the Rosendaal method
Time frame: 6 months
Rates of thrombosis between groups
Time frame: 6 months
Rates of major hemorrhage between groups
Time frame: 6 months
Patient satisfaction via postal survey
Time frame: 6 months
Rate of crossover from primary care physician group back to anticoagulation management service
Time frame: 6 months
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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University of Alberta