Simple Warfarin Dosing Algorithm Study (KT-INR)

Population Health Research Institute (PHRI)

Status

Completed

Conditions

Warfarin Dosing

Treatments

Other: Algorithm

Study type

Interventional

Funder types

Other

Identifiers

NCT01008215

09-282

Details and patient eligibility

About

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.

Full 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.

Enrollment

553 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.