Simple Warfarin Dosing Algorithm Study

NCT01008215 | Completed

• 1 other identifier: 09-282
• Study Type: interventional
• Target: 553
• Locations: 1 country
• Sites: 1

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.

Conditions

Warfarin Dosing

Keywords

INR Control; Warfarin dosing; Family physicians; Cluster randomization

Outcome Measures

Primary Outcomes (1)

• Mean time in therapeutic range for patients

  1 Year

Secondary Outcomes (3)

• 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

Study Arms (2)

Algorithm

EXPERIMENTAL

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

Other: Algorithm

Care as usual

NO INTERVENTION

Control group

Interventions

Algorithm OTHER

Warfarin Dosing algorithm (paper and electronic version)

Algorithm

Eligibility Criteria

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

You may qualify if:

• Family practices that:
• currently do not employ an evidence-based dosing method (anticoagulant clinic, computer system, manual algorithm or patient self-testing),
• manage warfarin maintenance dosing in at least 10 patients with target INR 2-3, and
• have at least one family physician providing written informed consent.
• Patients who:
• 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,
• patient provides written informed consent.

You may not qualify if:

• Family practices that:
• are planning to start employing an evidence-based method for warfarin dosing within the next year,
• are not expected to enroll at least 10 patients on long-term warfarin treatment with target INR 2-3.
• Patients:
• with \< 3 months warfarin management prior to the baseline observation,
• patients on warfarin with a target INR other than 2-3, and
• patients for whom warfarin is managed by a physician who is not participating in the trial.

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (1)

Caroline Medical Group

Burlington, Ontario, L7R 4C7, Canada

Location

MeSH Terms

Interventions

Algorithms

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

• Stuart Connolly

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 28, 2009
• First Posted: November 5, 2009
• Study Start: October 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 22, 2011

Record last verified: 2011-07

Locations

CA (1)