A Multicenter Controlled Trial of Anticoagulation Patient Self-Management in Germany Using the Protime System

Abstract number: P2336

El Rouby¹ S, for the German ProTime Study Group: Völler, H , Hartwig³ I, Kadar⁴ J, Dovifat² C, Taborski⁵ U, Wegscheider⁶ K, Zucker¹ ML, LaDuca¹ FM, Ansell⁷ J

¹¹ITC, Edison, NJ, USA ¹¹ITC, Edison, NJ, USA ²²Klinik Am See, Rüdersdorf, Germany ³³MtBASA, Berlin, Germany ⁴⁴Schlungszentrum Köln – West, Köln, Germany ⁵⁵Gesellschaft für Humanplasma, Bad Nauheim, Germany ⁶⁶Institute for Statistics and Econometry, University of Hamburg, Hamburg, Germany ⁷⁷Boston University Medical Center, Boston, USA

The proper management of oral anticoagulant therapy (OAT) requires optimizing time in range (TIR). As INR testing has progressed from routine medical management to anticoagulation clinic services, patient self-testing and patient self-management, studies have shown a concomitant improvement in TIR. PSM is the standard of care in Germany for ~70% of patients requiring OAT. A formal monitoring system specific training program, designed for the ProTime Microcoagulation System (ITC, Edison, NJ, USA) is currently under evaluation at three centers in Germany. This study is designed to evaluate the training program, TIR and satisfaction for 120 OAT patients. At enrollment, patients complete a self-assessment to determine their base knowledge of OAT prior to training. Following the two day training program, patients repeat the self-assessment and demonstrate the ability to obtain an accurate (within ±0.5 INR of professional result) INR before they are supplied with a ProTime for PSM. Patients return to the clinic after 1, 3 and 6 months to demonstrate INR testing proficiency and to complete satisfaction surveys regarding their OAT management. Assessment of 80 patients enrolled as of December 2004 revealed that these patients are much better informed on the management of OAT prior to training than anticipated from published reports despite wide variation in education level and time on OAT (0–109 months with 2 patients >15 years). Satisfaction and TIR were evaluated for 31of these patients who had completed at least one month of PSM following initial training. A statistically significant increase was seen in patient satisfaction related to their involvement in and comfort with OAT self-management. TIR averaged 64.4% in this population (range 30–97%).

These data support the use of the ProTime System for PSM as an appropriate monitoring method for appropriately trained OAT patients selected from diverse educational and socioeconomic backgrounds.