Simple Warfarin Dosing Algorithm Study (KT-INR)

Cluster Randomized Trial to Assess the Effect of Using a Simple Warfarin Maintenance Dosing Algorithm on the Quality of INR Control Among Canadian Family Practices

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.

Study Overview

• Status: Completed
• Conditions: Warfarin Dosing
• Intervention / Treatment: Other: Algorithm

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.

• Study Type: Interventional
• Enrollment (Actual): 553
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Burlington, Ontario, Canada, L7R 4C7
      • Caroline Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Algorithm; Algorithm (available in paper version and web-based version) will be used for warfarin maintenance dosing.	Other: Algorithm; Warfarin Dosing algorithm (paper and electronic version)
No Intervention: Care as usual; Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean time in therapeutic range for patients	1 Year

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with TTR > 65%	1 Year
Correlation between algorithm adherence and TTR	1 Year
Among patients in both baseline and study sample: proportion of patients with TTR improvement	1 Year

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Investigators: Principal Investigator: Stuart Connolly, McMaster University

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: October 28, 2009
• First Submitted That Met QC Criteria: November 4, 2009
• First Posted (Estimate): November 5, 2009

Study Record Updates

• Last Update Posted (Estimate): July 22, 2011
• Last Update Submitted That Met QC Criteria: July 20, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Cluster randomization; Family physicians; INR Control; Warfarin dosing
• Other Study ID Numbers: 09-282