Warfarin Self-Management for Anticoagulation Therapy

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Utah

Must be taking: Warfarin

Disqualifiers: Non-English speaking, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

In the US, patients receiving warfarin therapy are rarely allowed to engage in patient self-management (PSM) which is less burdensome, less expensive, and safer than standard clinic-directed warfarin management. The long-term objective of our application is to improve the safety of ambulatory warfarin therapy through increasing the implementation of PSM.

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 data supports the effectiveness of the treatment Warfarin Self-Management for Anticoagulation Therapy?

Research shows that patients who manage their own warfarin treatment can have better control over their therapy, reducing the risk of complications and improving their quality of life compared to those who rely on conventional management by doctors. ^{1 2 3 4 5}

Is self-management of warfarin therapy safe for patients?

Research shows that self-management of warfarin therapy is generally safe and can reduce the risk of complications compared to traditional management by doctors. It also improves patient satisfaction and quality of life. ^{1 3 5 6 7}

How is warfarin self-management different from other treatments for anticoagulation therapy?

Warfarin self-management allows patients to test their blood clotting levels at home using a small device and adjust their medication dose themselves, which can lead to better control and convenience compared to traditional management by doctors. This approach is particularly beneficial for those who travel frequently or have difficulty accessing labs, and it can improve patient satisfaction and reduce healthcare provider workload. ^{1 7 8 9 10}

Research Team

Eligibility Criteria

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

I do not speak English.

Inability or refusal to provide written informed consent

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

Trial Timeline

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

Treatment Details

Interventions

• Patient self-management (Other)
• Usual care provided by anticoagulation providers (Other)

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.

Participant Groups

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

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

Jeffrey Wilkins

University of Utah

Chief Medical Officer since 2022

MD from Meharry Medical College

Stephen Tullman

University of Utah

Chief Executive Officer since 2022

BS in Accounting from Rutgers University

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Dr. William Curry

Brigham and Women's Hospital

Chief Medical Officer

MD from Columbia University College of Physicians and Surgeons

Dr. Scott Schissel

Brigham and Women's Hospital

Chief Executive Officer since 2021

MD from Columbia University College of Physicians and Surgeons

Kaiser Foundation Research Institute

Collaborator

Trials

28

Recruited

21,300+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

Tennessee Valley Health Systems Veterans Affairs Medical Center

Collaborator

Trials

1

Recruited

150+

VA Loma Linda Health Care System

Collaborator

Trials

10

Recruited

770+

Findings from Research

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Patient self-management of oral anticoagulation: a review. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Comparing self-management of oral anticoagulant therapy with clinic management: a randomized trial. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Quality of Warfarin Therapy and Quality of Life are Improved by Self-Management for Two Years. [2020]

4. Norway pubmed.ncbi.nlm.nih.gov

Self-management of warfarin therapy. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Pilot study of a novel patient self-management program for warfarin therapy using venipuncture-acquired international normalized ratio monitoring. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Self-management of anticoagulation. [2013]

7. England pubmed.ncbi.nlm.nih.gov

A randomized trial of patient self-managed versus physician-managed oral anticoagulation. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

EMPoWARed: Edmonton pediatric warfarin self-management study. [2015]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Is home warfarin self-management effective? Results of the randomised Self-Management of Anticoagulation Research Trial. [2013]

10. Netherlands 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. [2023]