Atrial Fibrillation, Heart Valve Diseases, Venous Thromboembolism
Conditions
Keywords
Warfarin, Self-management, Implementation science, Anticoagulants
Brief 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. 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.
Interventions
Patient makes independent decisions regarding warfarin therapy changes using warfarin dosing tools
OTHERUsual care provided by anticoagulation providers
Normal care provided by anticoagulation providers
Sponsors
Brigham and Women's Hospital
University of Michigan
VA Loma Linda Health Care System
Kaiser Foundation Research Institute
University of Utah
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of patients transitioned to patient self-management | 6-months follow up | Percent of patients successfully transitioned to warfarin patient self-management |
| Time in therapeutic INR range (TTR) | Change from baseline at 6 months | Percent time INR in the therapeutic range |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Episodes of thromboembolic complications | 6-months follow | Objectively diagnosed stroke, venous thrombosis, systemic embolism |
| Mental and physical health-related quality of life scores | Change from baseline at 6 months | Mental and physical domains of quality of life as measured by the SF-12 survey |
| Patient satisfaction survey scores | Change from baseline at 6 months | Patient satisfaction as measured by the Anti-Clot Treatment Scale |
| Anticoagulation therapy knowledge scores | Change from baseline at 6 months | Scores measured by the Anticoagulation Knowledge Survey Tool |
| Episodes of major bleeding | 6-months follow up | Episodes of bleeding meeting ISTH definition for major bleeding |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient self-management cost effectiveness | 3-month cycles | Cohort simulation Markov model compared to usual care |
Countries
United States
Contacts
Primary ContactDaniel M Witt, PharmD
Outcome results
None listed