Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04766216 |
Other study ID # |
IRB_00141141 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
March 15, 2023 |
Est. completion date |
April 2024 |
Study information
Verified date |
March 2023 |
Source |
University of Utah |
Contact |
Daniel M Witt, PharmD |
Phone |
801-581-8851 |
Email |
dan.witt[@]pharm.utah.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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. The long-term objective of our application is to improve
the safety of ambulatory warfarin therapy through increasing the implementation of PSM.
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.