Enhanced Pharmacist-Managed Anticoagulation Service in a University-based Family Medicine Clinic

NACompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

October 31, 2016

Primary Completion Date

June 30, 2017

Study Completion Date

December 31, 2018

Conditions
AnticoagulationHome INR Monitoring
Interventions
DEVICE

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.

PROCEDURE

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.

All Listed Sponsors
lead

University of South Florida

OTHER

NCT03575936 - Enhanced Pharmacist-Managed Anticoagulation Service in a University-based Family Medicine Clinic | Biotech Hunter | Biotech Hunter