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

NCT00735189 | Completed Phase 4

• 1 other identifier: epicore ams1
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Warfarin

Keywords

warfarin; anticoagulation; anticoagulation clinics

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (5)

• 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

Study Arms (2)

1

EXPERIMENTAL

Patient continues to receive anticoagulation care from the Anticoagulation Management Service

Other: anticoagulation clinic care

2

ACTIVE COMPARATOR

Patient receives anticoagulation care from their usual primary care physician

Other: usual care

Interventions

anticoagulation clinic care OTHER

Patient receives care from the outpatient anticoagulation management service

1

usual care OTHER

patient receives usual anticoagulation care from their regular primary care physician

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• current patient of the Anticoagulation Management Service
• anticipated need for long term anticoagulation
• have a regular primary care physician

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

Study Officials

• Tammy J Bungard, PharmD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2008
• First Posted: August 14, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: June 24, 2010

Record last verified: 2010-06

Locations

CA (1)