Warfarin Self-Management for Anticoagulation Therapy

Recruiting at 1 trial location

Overseen By Daniel M Witt, PharmD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Must be taking: Warfarin

Disqualifiers: Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether patients can safely manage their own warfarin treatment at home, potentially reducing costs and simplifying the process compared to regular clinic visits. Warfarin, a blood thinner, is the focus of this study, which examines the safety and effectiveness of self-management versus traditional doctor-managed care. Individuals who have taken warfarin for at least nine months and can use a home device to check their blood's clotting time (INR) may be suitable candidates. Participants should be prepared to adjust their medication based on these results and have internet access to submit data online. As an unphased trial, this study offers a chance to contribute to research that could simplify treatment for many patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it requires that you have been on warfarin for at least 9 months before joining. It seems you need to continue taking warfarin during the study.

What prior data suggests that patient self-management for warfarin is safe?

Research has shown that when patients manage their own warfarin treatment, it is as safe as when doctors manage it. Studies in real-life situations have found no additional safety risks when patients handle their own warfarin doses. The likelihood of issues such as bleeding or blood clots remains similar whether patients manage their own treatment or not. In fact, self-management might be even safer due to more frequent monitoring. Data suggest that with proper support, patients can safely determine their own doses. Overall, the evidence supports that patient-managed warfarin is safe and well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about warfarin self-management for anticoagulation therapy because it empowers patients to take control of their treatment. Unlike the traditional approach where healthcare providers make all dosing decisions, this method allows patients to adjust their warfarin dose and schedule their next INR test based on their current results. This could lead to more personalized and timely adjustments, potentially improving patient outcomes and satisfaction. Additionally, it offers a more convenient option for patients, reducing the need for frequent clinic visits. This trial explores whether this self-management approach can be as effective and safe as the standard provider-managed care.

What evidence suggests that patient self-management of warfarin is effective for anticoagulation therapy?

Research shows that patients managing their own warfarin treatment, one of the approaches studied in this trial, can achieve safety comparable to clinic management. Studies have found that self-management often helps patients maintain their blood test results (INR values) within the safe range and reduces the risk of serious blood clots compared to regular care. Many patients find it less of a hassle, more cost-effective, and preferable. Overall, evidence suggests that self-managing warfarin treatment is a practical and effective option. ^{2 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have been on warfarin for at least 9 months, need to maintain an INR range of 2.0-3.5, and are willing to self-manage their treatment with home monitoring or clinic results. They must be able to make dosing decisions, test their INR every two weeks minimum, and have internet access.

Inclusion Criteria

Able to perform INR tests at least every 2 weeks

Demonstrate the willingness and ability to test their own INR using a home INR monitoring device or have same-day access to clinic-derived INR results (e.g., via electronic medical record secure messaging)

I am 18 or older and have been on warfarin for at least 9 months.

Exclusion Criteria

Inability or refusal to provide written informed consent

My target INR is not between 2.0-3.0 or 2.5-3.5.

I have had trouble following my warfarin treatment plan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Strategy Development

Develop and test PSM implementation strategies in US ambulatory care sites using rapid-cycle research methodology

3 months

Patient Self-Management

Patients manage decisions relating to warfarin dose and next INR test based on the results of current INR test

6 months

Follow-up

Participants are monitored for safety and effectiveness after transitioning to patient self-management

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient self-management
• Usual care provided by anticoagulation providers

Trial Overview

The study compares patient self-management of warfarin therapy using home INR monitoring devices against the usual care by clinics. It aims to see if patients can safely manage their own treatment effectively and less expensively.

How Is the Trial Designed?

Group I: Warfarin Patient Self-Management Experimental Treatment 1 Intervention

Patients managing decisions relating to warfarin dose and next INR test based on the results of current INR test

Group II: Historical Control Active Control 1 Intervention

Patients managed by anticoagulation providers prior to transitioning to warfarin patient self-management

Patient self-management is already approved in United States, European Union for the following indications:

Approved in United States as Coumadin/Jantoven for:

• Prevention and treatment of blood clots
• Deep venous thrombosis
• Pulmonary embolism
• Atrial fibrillation
• Heart valve replacement
• Open-heart surgery
• After a heart attack

Approved in European Union as Warfarin for:

• Prevention and treatment of blood clots
• Deep venous thrombosis
• Pulmonary embolism
• Atrial fibrillation
• Heart valve replacement
• Open-heart surgery
• After a heart attack

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Kaiser Foundation Research Institute

Collaborator

Trials

28

Recruited

21,300+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Tennessee Valley Health Systems Veterans Affairs Medical Center

Collaborator

Trials

1

Recruited

150+

VA Loma Linda Health Care System

Collaborator

Trials

10

Recruited

770+

Published Research Related to This Trial

Self-management of warfarin, which allows patients to test their own blood and adjust their medication, has shown to be feasible and may be more effective than traditional physician-managed care in maintaining proper anticoagulation control.

This approach offers several benefits, including convenience, quicker results for dosage adjustments, increased patient responsibility, and higher satisfaction, making it particularly useful for patients with limited access to labs or those who travel frequently.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient self-management of oral anticoagulation: a review. Sunderji, R., Fung, A., Gin, K., et al.[2016]

Patients who transitioned from conventional warfarin management to self-management showed a significant increase in time in therapeutic range (TTR), with a median of 78.1% compared to 65.9% during conventional management, indicating better control of anticoagulation therapy.

Self-management of warfarin not only reduced complications and extreme INR values but also improved patients' quality of life over a 2-year period, demonstrating its efficacy and safety as a management strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality of Warfarin Therapy and Quality of Life are Improved by Self-Management for Two Years. Sølvik, UØ., Løkkebø, E., Kristoffersen, AH., et al.[2020]

Self-management (SM) of warfarin by patients showed no significant improvement in maintaining therapeutic anticoagulation compared to physician management (PM), with 64.8% of SM patients and 58.7% of PM patients having their INR in range.

However, patients who self-managed their therapy spent significantly less time below the therapeutic range (15.0% vs. 27.3%), and all patients who completed the SM process preferred to continue with it, indicating it is a feasible and safe option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of patient self-managed versus physician-managed oral anticoagulation. Sunderji, R., Gin, K., Shalansky, K., et al.[2022]

In a study involving 23 patients over 27 weeks, self-management of warfarin therapy did not significantly improve the time in the therapeutic range (TTR) compared to conventional therapy, with TTRs of 70% and 75% respectively.

However, self-management resulted in a significantly lower percentage of extreme INR values (1.0% vs. 6.8% for conventional therapy), indicating better control of warfarin dosing and potentially reducing the risk of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management of warfarin therapy. Sølvik, UØ., Løkkebø, ES., Kristoffersen, AH., et al.[2015]

In a study involving 310 patients, those who self-managed their warfarin using the CoaguChek device maintained their INR levels within the target range as effectively as those receiving usual care from healthcare professionals, with a lower rate of out-of-range INR results (36% vs. 41%).

There were no significant differences in bleeding or thrombotic events between the self-management group and the usual care group, indicating that self-management is a safe alternative for long-term warfarin use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is home warfarin self-management effective? Results of the randomised Self-Management of Anticoagulation Research Trial. Dignan, R., Keech, AC., Gebski, VJ., et al.[2013]

Self-management of anticoagulation using portable coagulometers allows patients to measure their INR levels and adjust their warfarin doses, leading to better control of anticoagulation compared to traditional care methods.

Patients who self-manage their anticoagulation report higher satisfaction and improved quality of life, highlighting the benefits of this approach in managing vitamin K antagonist therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-management of anticoagulation. Levi, M.[2013]

Patient self-management (PSM) of warfarin therapy in children and their families is safe and effective, with a high time in therapeutic range of 90% to 92.9% over a median of 2.7 years, and no adverse events reported.

The study showed that PSM leads to improved health-related quality of life and sustained knowledge of warfarin management, indicating that families can effectively manage their child's therapy without significant dosing errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMPoWARed: Edmonton pediatric warfarin self-management study. Bauman, ME., Massicotte, MP., Kuhle, S., et al.[2015]

In a study of 737 patients, self-management of oral anticoagulant treatment resulted in a similar percentage of INR values within the target range compared to conventional management, with 58.6% in the self-management group versus 55.6% in the conventional group.

Patients in the self-management group experienced significantly fewer major complications (2.2% vs. 7.3%) and minor hemorrhages (14.9% vs. 36.4%) compared to those receiving conventional care, suggesting that self-management may enhance safety in anticoagulant therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. Menéndez-Jándula, B., Souto, JC., Oliver, A., et al.[2022]

Implementing a patient self-management (PSM) program for warfarin therapy in a U.S. academic health system led to similar or improved control of INR levels, which is crucial for safe anticoagulation management.

The PSM program also significantly reduced pharmacist workload by an estimated 68%, indicating that empowering patients to manage their therapy can enhance efficiency in healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation and evaluation of a warfarin patient self-management (PSM) program among experienced patients in a U.S. academic health system. Fleming, RP., Vazquez, SR., Witt, DM.[2023]

In a pilot study involving 44 patients with atrial fibrillation, a novel patient self-management (PSM) program for warfarin therapy did not significantly change the time in the therapeutic INR range (TTR), remaining at 82.9% before and 81.2% during the program.

The PSM program led to a significant increase in the number of INR tests performed per patient, from an average of 2.97 to 4.38 tests, while no major bleeding or thrombotic events occurred during the program, suggesting it is a safe approach for managing warfarin therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of a novel patient self-management program for warfarin therapy using venipuncture-acquired international normalized ratio monitoring. Simmons, BJ., Jenner, KM., Delate, T., et al.[2022]

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Patient self-management was not demonstrated to be superior to standard care, but was easily implemented and was the method preferred by patients.

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Data suggest that parents can be supported to make warfarin dosing decisions themselves, a process known as patient self-management (PSM). Objectives. This ...