PORTALS: design of an innovative approach to anticoagulation management through eHealth

Abstract

Background: For the monitoring of International Normalized Ratio (INR) values, venous thromboembolism (VTE) and atrial fibrillation (AF) patients can visit anticoagulation clinics, laboratories, or physicians for venous puncture. Point-of-care testing (POCT) made it possible for patients to monitor INR themselves (self-monitoring) and even self-adjust their medication dosage (self-dosage). Both skills are accepted as forms of self-management. eHealth applications can improve this self-management, resulting in better clinical outcomes.

Methods: Our study, called PORTALS, aims at identifying the optimal implementation strategy of training to improve self-management and explore factors that enhance good self-management skills. In addition, the relationship between the implementation strategy of training, clinical outcomes, and individual characteristics will be investigated. Of the 247 recruited participants, 110 chose to continue with regular care. 137 patients have been randomly divided in subgroups and compared using a parallel cohort design: one group will be trained and educated by e-learning, and the other group will receive face-to-face group training.

Discussion: More insight in factors that enhance good self-management will help to improve clinical outcomes and patient satisfaction on anticoagulation therapy. Our study will provide practical insights and knowledge of eHealth in daily practice and of the importance of education on the adoption of self-management. We expect the self-management program including training to help patients to better manage their own INR values and medication use, thereby increasing health status and diminishing thromboembolic events and hospitalisation.

Trial registration: The Netherlands National Trial Register, number NTR3947 .

Keywords: Anticoagulant therapy; Atrial fibrillation; Self-management; Self-monitoring; Venous thromboembolism; e-learning; eHealth.

Fig. 1

Subdivision within the Saltro Thrombosis Service into three groups; Groups 1 and 2 perform self-management; group 1 was instructed by e-learning and group 2 by group course. Group 3 receives the usual care, with brief instructions

Fig. 2

Schematic summary of recruitment; A schematic summary of the number of eligible patients, how many of them were approached, with what method they were approached, how many responded, how many are participating, and in which group

Fig. 3

Characteristics of eligible patients versus included patients; The average age, percentage of males, and average INR of eligible patients versus included patients is shown

Fig. 4

Time course for group 1, 2 and 3; The three groups and the time courses of their trainings, blood testing procedures, and instructions

Fig. 5

Measurements over time; A schematic overview of the different types of measurements on T1 = 0, T2 = 6, T3 = 12, and T4 = 18 months