Does Anticoagulant Control Change Following Referral Back to the Primary Care Physician?

Study Overview
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Brief Summary
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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.

Official Title
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Does Anticoagulant Control Change Following Referral Back to the Primary Care Physician? A Prospective Randomized Trial

Conditions
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Warfarin

Intervention / Treatment
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* Other: anticoagulation clinic care
* Other: usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: current patient of the Anticoagulation Management Service anticipated need for long term anticoagulation have a regular primary care physician Exclusion Criteria: previous failure of warfarin therapy (a bleed or clot despite therapeutic anticoagulation have a planned procedure (surgery) mandating discontinuation of warfarin are taking warfarin for a mechanical valve indication

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patient continues to receive anticoagulation care from the Anticoagulation Management Service | Other: anticoagulation clinic care<br>* Patient receives care from the outpatient anticoagulation management service<br>|
| Active Comparator: 2<br>Patient receives anticoagulation care from their usual primary care physician | Other: usual care<br>* patient receives usual anticoagulation care from their regular primary care physician<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of anticoagulation control (proportion of time in the therapeutic anticoagulation range +/- 0.5 INR unit) by the Rosendaal method. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time within expanded therapeutic range (+/- 0.7 INR unit) by the Rosendaal method |  | 6 months | 
| Rates of thrombosis between groups |  | 6 months | 
| Rates of major hemorrhage between groups |  | 6 months | 
| Patient satisfaction via postal survey |  | 6 months | 
| Rate of crossover from primary care physician group back to anticoagulation management service |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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warfarin, anticoagulation, anticoagulation clinics