42
Participants
Start Date
October 31, 2016
Primary Completion Date
June 30, 2017
Study Completion Date
December 31, 2018
Home INR Monitoring
The self-monitoring group will monitor INR at home using the AlereTM Home Monitoring Service. They will call in the weekly results to Alere or submit online via the patient portal, which is the standard protocol among home monitoring patients. Alere will then upload the information to a password-protected HIPAA compliant website that only study investigators will be able to access. Pharmacists will have real-time access to the test results via the web interface. Pharmacists can follow up in real time if the patient forgets to self-test. An alert will also be sent to the pharmacists via email to follow up on any out of range results. This will help streamline pharmacists' workload to dedicate face-to-face time for patients that require such intervention. All home monitoring patients will be seen in clinic by the pharmacist at the end of the 3-month randomization period in order to assess compliance with meter-use and re-evaluate meter-use competency.
Standard of Care
The patients in the standard of care group will have a clinic visit with the pharmacist at least once every 4 weeks or earlier, as deemed necessary by the pharmacist. The duration of the randomization period will be three months. At the end of the 3-month randomization period, patients will be provided the opportunity to cross over from the home INR monitoring group to the pharmacist-managed clinic group, or vice versa. The remainder of the study duration (post-3 month analysis) will purely be for observational purposes, in order to account for the loss of randomization and potential bias. The total duration of the study will be one year.
University of South Florida
OTHER