Enhancing postoperative anticoagulation therapy with remote patient monitoring: A pilot crossover trial study to evaluate portable coagulometers and chatbots in cardiac surgery follow-up

Author:

Guede-Fernández Federico12ORCID,Silva Pinto Tiago34ORCID,Semedo Helena34,Vital Clara34,Coelho Pedro345,Oliosi Maria Eduarda12ORCID,Azevedo Salomé16,Dias Pedro15ORCID,Londral Ana157

Affiliation:

1. Value for Health CoLAB, Lisboa, Portugal

2. LIBPhys (Laboratory for Instrumentation, Biomedical Engineering and Radiation Physics), NOVA School of Science and Technology, NOVA University of Lisbon, Caparica, Portugal

3. Área de Coração, Vasos e Tórax - Cirurgia Cardíaca, Hospital de Santa Marta, Unidade Local de Saúde São José, Lisboa, Portugal

4. Centro Clínico Académico de Lisboa, Lisboa, Portugal

5. Comprehensive Health Research Center, NOVA Medical School, NOVA University of Lisbon, Lisboa, Portugal

6. CEG-IST, Instituto Superior Técnico, University of Lisbon, Lisbon, Portugal

7. REAL Translation and Innovation Towards Global Health, NOVA School of Science and Technology, NOVA University of Lisbon, Caparica, Portugal

Abstract

Objective Prior research has not assessed the value of remote patient monitoring (RPM) systems for patients undergoing anticoagulation therapy after cardiac surgery. This study aims to assess whether the clinical follow-up through RPM yields comparable outcomes with the standard protocol. Methods A crossover trial assigned participants to SOC-RPM or RPM-SOC, starting with the standard of care (SOC) for the first 6 months after surgery and using RPM for the following 6 months, or vice-versa, respectively. During RPM, patients used the Coaguchek© to accurately measure International Normalized Ratio values and a mobile text-based chatbot to report PROs and adjust the therapeutic dosage. The study assessed patients’ and clinicians’ experience with RPM and compared direct costs. Results Twenty-seven patients participated. The median time in therapeutic range (TTR) levels during RPM were 72.2% and 50.6% for the SOC-RPM and RPM-SOC arms, respectively, and during SOC, they were 49.4% and 58.4% for SOC-RPM and RPM-SOC arms, respectively. Patients and the clinical team reported high trust and satisfaction with the proposed digital service. Statistically significant differences were only found in the cost of RPM in the RPM-SOC, which was higher than SOC in the SOC-RPM arm. Conclusions Portable coagulometers and chatbots can enhance the remote management of patients undergoing anticoagulation therapy, improving patient experience. This presents a promising alternative to the current standard procedure. The results of this study seem to suggest that RPM may have a higher value when initiated after a SOC period rather than starting RPM immediately after surgery. Trial registration: ClinicalTrials.gov NCT06423521.

Funder

Roche Diagnostics

Agência Nacional de Inovação

Publisher

SAGE Publications

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