Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Atrial Fibrillation
  • Heart Valve Diseases
  • Venous Thromboembolism
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Crossover AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 ove...

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.

Tracking Information

NCT #
NCT04766216
Collaborators
  • Brigham and Women's Hospital
  • University of Michigan
  • Tennessee Valley Health Systems Veterans Affairs Medical Center
  • VA Loma Linda Health Care System
  • Kaiser Foundation Research Institute
Investigators
Not Provided