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Impact of Electronic Transmission of Patient PT/INR Home Self-Testing Results

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Terea Williamson*, DPT, BS1, Stuart Blackwell, BA1, Brittany Compton, BSN, RN1, Paul Sommers, BSN, RN1, Seok-Won Lee, PhD2, JoAnne Resnic, MBA, BSN, RN3, Sandra Gomberg, DNP3�1Orthodynamics Company, Inc. (ODI), Noblesville, IN, United States2CoaguSense, Inc., Fremont, CA, United States3Stel, Life, Inc. , Philadelphia, PA, United States

Introduction

Results

Objectives

References

Conclusion

Methods

Left ventricular assist devices (LVAD) are the therapy of choice for end-stage-heart failure as a bridge to transplant or for permanent use.1 The LVAD one year survival rate is as high as 82%, predicated on monitoring patients at risk for adverse events such as bleeding.2  Prothrombin Time/ International Normalized Ratio (PT/INR) testing is the ‘gold standard’ for monitoring bleeding risks.  Patients who complete PT/INR self-test on a weekly basis demonstrate a higher than 75% time within therapeutic range compared to usual care.3  Electronic interfaces are the safest and most reliable methods to transmit data from laboratory instruments to clinical systems preventing reporting delays and transcription errors.4

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To determine the impact of passive digital transmission of patient �PT/INR home self-testing results using the Stel Vitals Hub and the �Coag-Sense® CLIA-waived PT/INR device compared to usual �methods:

  • Patient emailing staff
  • Patient entering data into the ODI clinical platform
  • Telephonically reporting test results to clinical care team

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ODI’s multidisciplinary team designed a weekly home monitoring program that included the Coag-Sense® CLIA-waived PT/INR device, the Stel Life Vitals Hub and ODI’s customized platforms (VADTrac & INRTrac) and offered two methods of PT/INR result reporting.  �Reporting Method 1: �Patients use the Stel Vitals Hub which securely transmits the test results from the Coag-Sense® PT/INR device directly into ODI clinical platforms. �Reporting Method 2:�Patients report results by calling or emailing ODI which requires ODI staff to transcribe the data, or patients to enter data directly into the portal. �

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ODI analyzed the differences in patient self-testing compliance among 520 patients using the two methods between January 1 and December 2, 2022.  Patients using the Stel Vitals Hub submitted 9986 results with 75.3% submitted within the expected timeframe.  Self-reporting patients submitted 2740 results with 70% submitted within the expected timeframe

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Passive digital transmission of point of care PT/INR home test results can reduce patient and staff workload, support patient timely testing compliance, and aid in eliminating the risk of transcription errors.

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  1. Veenis, J.F., Brugts, J.J. Remote monitoring for better management of LVAD patients: the potential benefits of CardioMEMS. Gen Thorac Cardiovasc Surg 68, 209–218 (2020). https://doi.org/10.1007/s11748-020-01286-6.
  2. Bowen RES, Graetz TJ, Emmert DA, Avidan MS. Statistics of heart failure and mechanical circulatory support in 2020. Ann Transl Med. 2020 Jul;8(13):827. doi: 10.21037/atm-20-1127. PMID: 32793672; PMCID: PMC7396255.
  3. Siebenhofer A, Rakovac I, Kleespies C, Piso B, Didjurgeit U. Self-management of oral anticoagulation in the elderly: rationale, design, baselines and oral anticoagulation control after one year of follow-up. A randomized controlled trial. Thromb Haemost. 2007 Mar;97(3):408-16. PMID: 17334508.
  4. Mays JA, Mathias PC. Measuring the rate of manual transcription error in outpatient point-of-care testing. J Am Med Inform Assoc. 2019 Mar 1;26(3):269-272. doi: 10.1093/jamia/ocy170. PMID: 30649499; PMCID: PMC6351970.

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*Corresponding Author

ODI clinical platform

Stel Vitals Hub

Coag-Sense®

PT/INR meter