Atrial FibrillationNCT04766216
Warfarin Patient Self-management Implementation in the US Healthcare System
A study testing Patient self-management in people with Atrial Fibrillation and Venous Thromboembolism, run by University of Utah at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Venous Thromboembolism, Heart Valve Diseases
- What is being tested?
- Patient self-management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesUnited States
- Study dates
- 15 Mar 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites, 2 recruiting
- Completed
University of Michigan
Ann Arbor, Michigan, 48109
- Completed
Brigham and Women's Hospital
Boston, Massachusetts, 02115
- Recruiting
VA Loma Linda Healthcare System
Loma Linda, California, 92357
Linh Chan, PharmD, 909-894-7996, Linh.Chan@va.gov
- Recruiting
University of Utah Thrombosis Center
Salt Lake City, Utah, 84112
Sara Vazquez, PharmD, 801-581-3449, sara.vazquez@hsc.utah.edu
Daniel M Witt, PharmD, 801-581-8851, dan.witt@pharm.utah.edu
About this study
Official title: Overcoming Barriers to Warfarin Patient Self-management Implementation in the US Healthcare System
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.
Read the detailed description
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 clinician-directed warfarin management. National and international evidence-based guideline panels strongly recommend PSM over other warfarin management methods for appropriate patients because it improves INR control, cuts risk of thrombosis and death by half without increasing bleeding risk, and increases patient satisfaction and quality of life. The reasons behind PSM underutilization in US settings have not been systematically assessed and validated. We will address this knowledge gap and provide foundational information for increasing PSM utilization within the US healthcare system. Our Aim 1 will assess and validate barriers and facilitators to PSM and evaluate their applicability to the US healthcare system; Aim 2 will develop and test PSM implementation strategies in US ambulatory care sites using rapid-cycle research methodology; and Aim 3 will assess implementation (feasibility, fidelity, adoption), clinical (effectiveness, safety, equity, patient-centeredness), and end-user (satisfaction) outcomes. The long-term objective of our application is to improve the safety of ambulatory warfarin therapy through increasing the implementation of PSM. Our research proposal is guided by an implementation science logic model that incorporates well-known implementation science frameworks to support the specific aims. Qualitative data collection and analysis for Aim 1 will be organized using the Consolidated Framework for Implementation Research (CFIR) a determinant framework that identifies five domains influencing implementation: Intervention, Inner Setting, Outer Setting, Individuals, and the Implementation Process. Constructs within each domain provide guidance on factors to identify and measure as potential implementation barriers or facilitators. PSM implementation activities in Aim 2 will be guided by the Quality Implementation Framework (QIF), which identifies the critical implementation process steps and specific actions related to these steps that can be utilized to achieve quality PSM implementation. Implementation strategies will be supported by the rapid-cycle research framework developed by the AHRQ Practice Based Research Network. Implementation outcomes in Aim 3 will be structured using the well-known Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM) framework. We will utilize a type III hybrid research design to test PSM implementation strategies while observing/gathering information on PSM-related clinical and economic outcomes.
- Being tested
- Patient self-management, Usual care provided by anticoagulation providers
- Keywords
- Warfarin, Self-management, Implementation science, Anticoagulants
- Medical subject headings
- Atrial Fibrillation, Venous Thromboembolism, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient self-managementOther
Patient makes independent decisions regarding warfarin therapy changes using warfarin dosing tools
Usual care provided by anticoagulation providersOther
Normal care provided by anticoagulation providers
| Study group | Role | What they receive |
|---|---|---|
| Warfarin Patient Self-Management | Experimental | Patients managing decisions relating to warfarin dose and next INR test based on the results of current INR test Receives: Other: Patient self-management |
| Historical Control | Active comparator | Patients managed by anticoagulation providers prior to transitioning to warfarin patient self-management Receives: Other: Usual care provided by anticoagulation providers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in therapeutic INR range (TTR)
Percent time INR in the therapeutic range
Measured: Change from baseline at 6 months
Percent of patients transitioned to patient self-management
Percent of patients successfully transitioned to warfarin patient self-management
Measured: 6-months follow up
Secondary outcomes (5)
Episodes of major bleeding
Episodes of bleeding meeting ISTH definition for major bleeding
Measured: 6-months follow up
Episodes of thromboembolic complications
Objectively diagnosed stroke, venous thrombosis, systemic embolism
Measured: 6-months follow
Mental and physical health-related quality of life scores
Mental and physical domains of quality of life as measured by the SF-12 survey
Measured: Change from baseline at 6 months
Anticoagulation therapy knowledge scores
Scores measured by the Anticoagulation Knowledge Survey Tool
Measured: Change from baseline at 6 months
Patient satisfaction survey scores
Patient satisfaction as measured by the Anti-Clot Treatment Scale
Measured: Change from baseline at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start15 Mar 2023
- Primary completion31 May 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, University of Michigan, VA Loma Linda Health Care System, Kaiser Foundation Research Institute
- Responsible party
- Principal investigator, Daniel Witt, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04766216
- Sponsor's protocol ID
- IRB_00141141
- Status last verified
- May 2024
- First submitted
- 16 Feb 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Witt DM, Hong H, Wilson AS, Jones AE, Vazquez SR, Gilbert SJ, Malone DC, Chaiyakunapruk N, King JB, Barnes GD, Sylvester KW, Chan L, Delate T. Warfarin Patient Self-Management in the US Health Care System: A Nonrandomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e262627. doi: 10.1001/jamanetworkopen.2026.2627.
PubMed 41854610
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overcoming Barriers to Warfarin Patient Self-management Implementation in the US Healthcare System
- ClinicalTrials.gov ID
- NCT04766216
- Acronym / sponsor ID
- IRB_00141141
- Keywords
- Warfarin, Self-management, Implementation science, Anticoagulants
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, University of Michigan, VA Loma Linda Health Care System, Kaiser Foundation Research Institute
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 clinician-directed warfarin management. National and international evidence-based guideline panels strongly recommend PSM over other warfarin management methods for appropriate patients because it improves INR control, cuts risk of thrombosis and death by half without increasing bleeding risk, and increases patient satisfaction and quality of life. The reasons behind PSM underutilization in US settings have not been systematically assessed and validated. We will address this knowledge gap and provide foundational information for increasing PSM utilization within the US healthcare system. Our Aim 1 will assess and validate barriers and facilitators to PSM and evaluate their applicability to the US healthcare system; Aim 2 will develop and test PSM implementation strategies in US ambulatory care sites using rapid-cycle research methodology; and Aim 3 will assess implementation (feasibility, fidelity, adoption), clinical (effectiveness, safety, equity, patient-centeredness), and end-user (satisfaction) outcomes. The long-term objective of our application is to improve the safety of ambulatory warfarin therapy through increasing the implementation of PSM. Our research proposal is guided by an implementation science logic model that incorporates well-known implementation science frameworks to support the specific aims. Qualitative data collection and analysis for Aim 1 will be organized using the Consolidated Framework for Implementation Research (CFIR) a determinant framework that identifies five domains influencing implementation: Intervention, Inner Setting, Outer Setting, Individuals, and the Implementation Process. Constructs within each domain provide guidance on factors to identify and measure as potential implementation barriers or facilitators. PSM implementation activities in Aim 2 will be guided by the Quality Implementation Framework (QIF), which identifies the critical implementation process steps and specific actions related to these steps that can be utilized to achieve quality PSM implementation. Implementation strategies will be supported by the rapid-cycle research framework developed by the AHRQ Practice Based Research Network. Implementation outcomes in Aim 3 will be structured using the well-known Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM) framework. We will utilize a type III hybrid research design to test PSM implementation strategies while observing/gathering information on PSM-related clinical and economic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Warfarin Patient Self-Management | Experimental | Other: Patient self-managementPatients managing decisions relating to warfarin dose and next INR test based on the results of current INR test |
| Historical Control | Active comparator | Other: Usual care provided by anticoagulation providersPatients managed by anticoagulation providers prior to transitioning to warfarin patient self-management |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient self-managementPatient makes independent decisions regarding warfarin therapy changes using warfarin dosing tools | Other | Warfarin Patient Self-Management |
| Usual care provided by anticoagulation providersNormal care provided by anticoagulation providers | Other | Historical Control |
Primary outcome
Time in therapeutic INR range (TTR)
Time frame: Change from baseline at 6 months
Percent time INR in the therapeutic range
Percent of patients transitioned to patient self-management
Time frame: 6-months follow up
Percent of patients successfully transitioned to warfarin patient self-management
5 secondary outcomes
Episodes of major bleeding
Time frame: 6-months follow up
Episodes of thromboembolic complications
Time frame: 6-months follow
Mental and physical health-related quality of life scores
Time frame: Change from baseline at 6 months
Anticoagulation therapy knowledge scores
Time frame: Change from baseline at 6 months
Patient satisfaction survey scores
Time frame: Change from baseline at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 41854610Witt DM, Hong H, Wilson AS, Jones AE, Vazquez SR, Gilbert SJ, Malone DC, Chaiyakunapruk N, King JB, Barnes GD, Sylvester KW, Chan L, Delate T. Warfarin Patient Self-Management in the US Health Care System: A Nonrandomized Clinical Trial. JAMA Netw Open. 2026 Mar 2;9(3):e262627. doi: 10.1001/jamanetworkopen.2026.2627.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient self-management in people with Atrial Fibrillation and Venous Thromboembolism, run by University of Utah at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel M Witt, PharmD (801-581-8851, dan.witt@pharm.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in therapeutic INR range (TTR) (time frame: Change from baseline at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04766216, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024; AzTrials last refreshed its copy on 6 Nov 2026.