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Presentation Details
Overcoming Barriers to Warfarin Patient Self-Management in the US Healthcare System (THSNA �Travel Awardee)

Daniel M.Witt1, 2, Heeseung Hong1, 2, Aaron S.Wilson1, Aubrey E.Jones1, 2, Sara R.Vazquez1.2, Spencer Gilbert1, 2, Daniel C.Malone1, Nathorn Chaiyakunapruk1, 3, Jordan B.King4, 5, Geoffrey D.Barnes6, Katelyn W.Sylvester7, Linh Chan8, Thomas Delate9.

1University of Utah College of Pharmacy, Salt Lake City, UT, USA.2University of Utah Health Thrombosis Service, Salt Lake City, UT, USA.3IDEAS Center, Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, UT, USA.4University of Utah School of Medicine, Salt Lake City, UT, USA.5Institute for Health Research kaiser Permanente Colorado, Aurora, CO, USA.6University of Michigan, Ann Arbor, MI, USA.7Brigham and Women's Hospital, Boston, MA, USA.8Loma Linda Veterans Affairs Healthcare System, Loma Linda, CA, USA.9Kaiser Permanente National Pharmacy, Aurora, CO, USA

Abstract


Background: Warfarin patient self-management (PSM) has consistently demonstrated superior efficacy to clinic-based management and is recommended by evidence-based guidelines. However, it is rarely used in the United States (US) healthcare system. Objective: To implement and evaluate PSM in healthcare systems within the US using strategies that overcome previously identified barriers associated with PSM underutilization. Methods: This was a single-arm implementation open-label trial conducted between March 2023 and January 2024. The follow up period was 6-months. Four anticoagulation management services across the US enrolled patients who had been taking warfarin for at least 9-months and were using home international normalized ratio (INR) monitors. The intervention was transition to PSM using an implementation toolkit developed to address barriers specific to self-monitoring in the US healthcare system. Implementation and clinical outcomes were assessed using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework and included the proportion of patients successfully transitioned to self-monitoring, time in the therapeutic INR range, bleeding and thromboembolic events, and proportion of INRs managed independently by patients. Results: Reach: Of the 255 patients invited to participate in the trial, 138 (54.0%) consented, of which 58.0% were male, 84.8% were White, 89.1% were non-Hispanic/Latino, and 92.0% had been receiving warfarin therapy for 2 or more years. Among consented participants 120 (87.0%) successfully transitioned to PSM and completed 6 months of follow up. Effectiveness: Compared to baseline, time in therapeutic INR range during self-management improved from 77.1% to 81.3% (p=0.048) (see Fig. 1). The proportion of out-of-range INRs declined from 32.5% to 29.0% in the 6-months before and after PSM transition (p=0.018). During the self-management phase 5 bleeding events and no thromboembolic events or deaths occurred. Differences in adverse events in the 6-months before and after self-management initiation were not statistically significant (p=0.48). Adoption: Younger age was the only factor independently associated with willingness to participate in the PSM implementation study (adjusted odds ratio 0.97, 95% confidence interval 0.95-0.99). Implementation: During the PSM phase, warfarin dose changes in response to out-of-range INRs were made independently by participants in 83.0% of cases. Participants mainly used their own experience when making warfarin dose changes (66.6% of cases) verses using the online warfarin dosing tool (21.6% of cases) or other dosing decision support tools (11.8% of cases). Using their own experience for warfarin dosing was rated as being very useful or useful by 97.4% of participants as compared to 74.1% and 56.9% for the online dosing tool and other dosing tools, respectively. Maintenance: At the conclusion of the study 84.4% of participants expressed a preference for continuing self-management and clinicians expressed comfort with 94.0% of participants continuing self-management after the study. Conclusions: Within the context of a single arm implementation trial, warfarin PSM was safely and effectively implemented in most participants. Time in the therapeutic INR range improved significantly during PSM. Most participants and clinicians endorsed continuing PSM after the end of the study. These results provide critically needed evidence to facilitate and accelerate self-management implementation in the US healthcare system.

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