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OpenTrials
Completed

NCT Number: NCT00735189

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

anticoagulation clinic care

Other

Patient receives care from the outpatient anticoagulation management service

Usual Care

Other

patient receives usual anticoagulation care from their regular primary care physician

Primary outcomes

  1. Adequacy of anticoagulation control (proportion of time in the therapeutic anticoagulation range +/- 0.5 INR unit) by the Rosendaal method.

    Time frame: 6 months

Secondary outcomes

  1. Time within expanded therapeutic range (+/- 0.7 INR unit) by the Rosendaal method

    Time frame: 6 months

  2. Rates of thrombosis between groups

    Time frame: 6 months

  3. Rates of major hemorrhage between groups

    Time frame: 6 months

  4. Patient satisfaction via postal survey

    Time frame: 6 months

  5. Rate of crossover from primary care physician group back to anticoagulation management service

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Aug 14, 2008
Registry last updated
Jun 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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