Key result
At-home INR self-testing is linked to a ~3% increase in time in therapeutic range.
Why the study?
It was uncertain if patients taking warfarin managed face-to-face or by telephone could be as effectively managed with less frequent interaction through self-testing at home.
Does INR self-testing at home improve time in therapeutic range in patients taking warfarin compared to face-to-face or telephone management?
Observational
No
Does INR self-testing at home improve time in therapeutic range in patients taking warfarin compared to face-to-face or telephone management?
Mean Difference: 3.3
Absolute Event Rate: 73.2% vs 69.9%
p-value: p=0.047
A self-testing program for warfarin management with limited clinician interaction significantly improved time in therapeutic range compared to traditional face-to-face or telephone management.
Self-testing was associated with higher TTR in this cohort; leaves open whether RCTs confirm benefit before practice change.
Purpose Patients managed by the Froedtert & the Medical College of Wisconsin (F&MCW) Anticoagulation Clinics (ACC) have three monitoring options: face‐to‐face management, telephone management, or self‐testing management with limited clinician interaction only when International Normalized Ratios (INRs) are out of range or when clinically appropriate. To investigate if F&MCW ACC's current method of less frequent interaction for self‐testing is safe and effective, the purpose of this study was to determine if patients taking warfarin who were previously managed either face‐to‐face or via telephone call in the F&MCW ACC can be as effectively managed while self‐testing at home. Methods This pre‐post study analyzed data from face‐to‐face or telephone call anticoagulation management 6 months before and after each patient's self‐testing teach‐visit date. The primary outcome was the patients' time in therapeutic range (TTR) for INR values before and after enrolling in the self‐testing program. Secondary outcomes were the number of major bleeding and thromboembolic events and the number of INRs greater than 5.0 before and after transitioning to INR self‐testing. Patients served as their own control group for all outcomes of this study. Results The mean (standard deviation [SD]) TTR for subjects 6 months before and after transitioning to self‐testing was 69.9% (20.9) and 73.2% (18.0), respectively, demonstrating a statistically significant increase in TTR of 3.3% (25.4) with self‐testing (P = .047). Thirty‐six critical values occurred in the 6 months before self‐testing and 24 occurred in the 6 months after transitioning to self‐testing (P = .23). Additionally, four major bleeding and thromboembolic events occurred in four different patients in the 6 months after transitioning to self‐testing (P = .13). Conclusions F&MCW ACC's model for self‐testing management of every 2‐week self‐tests and limited clinician interaction demonstrates statistically significant improvements in TTR after patients transitioned to self‐testing. There was no statistically significant increase in adverse events following this transition.
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Romano et al. (2020) conducted an observational in Patients taking warfarin requiring anticoagulation management. Anticoagulation self-testing program vs. Face-to-face or telephone management (pre-transition) was evaluated on Time in therapeutic range (TTR) for INR values (Mean difference 3.3%, p=0.047). Transitioning to an at-home anticoagulation self-testing program significantly increased patients' mean time in therapeutic range from 69.9% to 73.2% (P=0.047).
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