Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04766216
Status:
RECRUITING
Last Update Posted:
2024-05-08
First Post:
2021-02-16
Brief Title:
Warfarin Patient Self-management Implementation in the US Healthcare System
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Overcoming Barriers to Warfarin Patient Self-management Implementation in the US Healthcare System
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 observinggathering information on PSM-related clinical and economic outcomes
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None