Remote Home Prothrombin Time (PT)/International Normalized Ratio (INR) Monitoring and Patient Management System
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional

Summary: 
      Long-term anticoagulation is indicated in patients for the prophylaxis and/or treatment of
      the thromboembolic complications associated with atrial fibrillation and/or mechanical
      cardiac valve replacement, prevention or treatment of venous thromboembolism (deep vein
      thrombosis and pulmonary embolism), to prevent thromboembolic events post-myocardial
      infarction, and in patients with systemic embolic events. Currently the only approved oral
      medication for anticoagulation is warfarin (Coumadin, Bristol-Myers Squibb and generic
      warfarin. Dosage is controlled by periodic determinations of the prothrombin time
      (PT)/International Normalized Ratio (INR). Under treatment may lead to venous or arterial
      thrombotic events or stroke, while over treatment may lead to major bleeding and even death.
      Patients require frequent INR monitoring to maintain a therapeutic level of anticoagulation.
      The therapeutic INR range varies by clinical indication, most commonly an INR 2-3 goal, but
      ranging from 1.5-4.0. Bleeding complications are more likely to occur above an INR value of
      4.0. The vMetrics - Anticoagulation Management System is a remote patient management solution
      for Oral Anticoagulation Care patients. This system provides confirmation of patient question
      and testing protocols as well as virtual patient management care capability for dosage and
      patient scheduling. This trial will provide end points to ascertain efficiency against
      standard care protocol and confirm equivalent care standards.
    

Detailed description: 
      The creation of optimal devices for patient self-testing protocols for anticoagulation
      management is an area of active medical research. The current pilot study represents the
      initial step in the development of a new customized device for this purpose, the vMetrics -
      Anticoagulation Monitoring System. The v-Metrics Anticoagulation Monitoring System (vMetrics
      AMS) is defined by: 1. A PT/INR home monitoring unit which interfaces to FDA approved PT/INR
      home monitors such as the Hemosense INRatio device, and 2. an anticoagulation clinic patient
      management application which manages patient communications, database of prior test results,
      testing schedules, and communication to an EMR.

      The INR home-monitoring system to be tested in this study will address several of the
      limitations of currently available technologies and practices for standard and home INR
      self-testing. The proposed project will develop a self-testing device that maximizes safety
      and efficiency for both the patient and the health care provider. The monitoring device
      (vMetrics) allows the wireless transmission of the INR result from an approved home INR
      measuring monitoring device (ex:HemoSense - INRatio) to a secure database in a health care
      provider staffed anticoagulation clinic. The device will also collect yes/no responses to a
      set of standard questions from the subject to assure patient safety and determine optimal
      Coumadin dosing. Upon receipt of the patient data, the Coumadin provider can review the INR
      result and responses to the questions and use standard Coumadin dosing protocols and clinical
      judgment to transmit dosing instructions back to the patient through the device. A calendar
      schedule of dosing until the next scheduled INR check will be transmitted to the patient. In
      certain instances (i.e., high INR > 5), the device will transmit instructions to call the
      Coumadin clinic. The subject will confirm receipt of the Coumadin dose sent to him/her by
      pressing a button on the device (which transmits the confirmation back to the database). This
      process may reduce inconvenience to the subject, the INR value is reported directly from the
      device reducing the possibility of error, two-way communication is wireless and will reduce
      the need for telephone contact, thus potentially saving health care provider and patient
      time. In addition, the data from the encounter will be available in a form that can be
      entered into the patient's electronic medical record. The patient will enter data into the
      device using a 4-digit passcode that will allow for security of data.

      In addition to coordinating INR transmission through the home INR device, a customized
      database will provide a platform for the anticoagulation clinic patient management
      application (Wireless Home Coumadin clinic). This platform which will organize the workflow
      of the Coumadin provider to more easily determine which patients are due (or overdue) for
      monitoring, and which patients have transmitted an INR value and questionnaire and are
      awaiting a response.
    

Intervention name(s): vMetrics protocol
Intervention type(s): Other
Intervention description(s): use vmetrics protocol and device or use standard in clinic monitoring
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Systemic embolic events; Thromboembolic Complications with Atrial Fibrillation; Prophylaxis with Atrial Fibrillation; Mechanical Cardiac Valve Replacement