Simple Warfarin Dosing Algorithm Study

NCT ID: NCT01008215

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 553 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-06-30

Brief Summary

Can a simple and cost-free tool help family physicians to improve dosing of the blood thinner warfarin?

Warfarin is a blood thinner with a variable effect and requires regular blood monitoring and dose adjustments. Some family practices do not have the facilities or funding to use commercial tools than can assist with stabilizing the effect of warfarin. The investigators will test whether a simple and cost-free dosing tool can help these practices to improve warfarin management.

If this simple tool improves warfarin management, it will be freely available for practices in Canada and around the world. This will help physicians who have no access to more costly and/or complicated tools improve their warfarin dosing practice in a systematic fashion, and thereby maximize the health benefit of warfarin.

Detailed Description

Warfarin reduces the risk of thromboembolism, but requires regular blood monitoring to keep the international normalized ration (INR) within a narrow therapeutic range to achieve maximum benefits. A low proportion of time spent within the therapeutic INR range, (TTR) is associated with reduced warfarin efficacy and potentially harmful results. To optimize TTR, international guidelines recommend the use of systematic evidence-based dosing methods (anticoagulation clinic, computerized systems, manual algorithm and patient self-management). A survey in the Hamilton area revealed that half of family physicians manage warfarin dosing without assistance from an evidence-based method. The simple manual dosing algorithm is a simple tool that helped increase the TTR at the Hamilton General Hospital's anticoagulant clinic to an excellent 73% among patients with target INR range 2-3. We will test whether the simple dosing algorithm can help to improve warfarin dosing of family physicians who are not assisted by evidence-based methods. We will randomize family practices to either use the simple dosing algorithm or to manage warfarin dosing as usual, to test whether the simple dosing algorithm achieves a superior TTR.

Conditions

Warfarin Dosing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Algorithm

Algorithm (available in paper version and web-based version) will be used for warfarin maintenance dosing.

Group Type: EXPERIMENTAL

Algorithm

Intervention Type: OTHER

Warfarin Dosing algorithm (paper and electronic version)

Care as usual

Control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Algorithm

Warfarin Dosing algorithm (paper and electronic version)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Family practices that:

1. currently do not employ an evidence-based dosing method (anticoagulant clinic, computer system, manual algorithm or patient self-testing),

2. manage warfarin maintenance dosing in at least 10 patients with target INR 2-3, and

3. have at least one family physician providing written informed consent.

• Patients who:

1. are on long-term warfarin treatment (> 6 weeks before study entry and expected to continue for at least 6 more months) with target INR 2-3, for whom warfarin is managed by a participating family physician,

2. patient provides written informed consent.

Exclusion Criteria

• Family practices that:

1. are planning to start employing an evidence-based method for warfarin dosing within the next year,

2. are not expected to enroll at least 10 patients on long-term warfarin treatment with target INR 2-3.

• Patients:

1. with < 3 months warfarin management prior to the baseline observation,

2. patients on warfarin with a target INR other than 2-3, and

3. patients for whom warfarin is managed by a physician who is not participating in the trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

McMaster University

Principal Investigators

Stuart Connolly

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Caroline Medical Group

Burlington, Ontario, Canada

Countries

Canada

Other Identifiers

09-282

Identifier Type: -

Identifier Source: org_study_id