Improving warfarin management through patient self-management
Overcoming Barriers to Warfarin Patient Self-management Implementation in the US Healthcare System
This study is testing whether teaching patients to manage their own warfarin treatment can make it safer and more effective for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Utah Academic / other |
| Locations | 4 sites (Loma Linda, California and 3 other locations) |
| Trial ID | NCT04766216 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the safety and effectiveness of warfarin therapy by implementing patient self-management (PSM) strategies in the US healthcare system. It will assess barriers and facilitators to PSM, develop and test implementation strategies in ambulatory care settings, and evaluate various outcomes including feasibility, effectiveness, and patient satisfaction. The research is guided by established implementation science frameworks to ensure a systematic approach to increasing PSM utilization. The ultimate goal is to improve INR control and patient quality of life while reducing risks associated with warfarin therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have been on warfarin therapy for at least 9 months and are willing to self-manage their INR testing and dosing.
Not a fit: Patients with a goal INR range outside of 2.0-3.0 or 2.5-3.5, or those with known poor adherence to warfarin therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective management of warfarin therapy for patients.
How similar studies have performed: Previous studies have shown that patient self-management can significantly improve outcomes in anticoagulation therapy, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years of age treated with warfarin for any indication for at least 9 months prior to enrollment * 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) * Willing to make independent decisions about warfarin dosing based on INR results * Able to perform INR tests at least every 2 weeks * Currently have and willing to maintain internet access for the duration of the study in order to complete online data collection forms * Have an anticipated duration of warfarin therapy of at least 6 months Exclusion Criteria: * Goal INR range other than 2.0-3.0 or 2.5-3.5 * Known poor adherence to warfarin therapy * Non-English speaking * Inability or refusal to provide written informed consent
Where this trial is running
Loma Linda, California and 3 other locations
- VA Loma Linda Healthcare System — Loma Linda, California, United States (Recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Completed)
- University of Michigan — Ann Arbor, Michigan, United States (Completed)
- University of Utah Thrombosis Center — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Daniel M Witt, PharmD
- Email: dan.witt@pharm.utah.edu
- Phone: 801-581-8851
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.