Remote Interactive Monitoring of Patients on Anticoagulant Therapy to Improve Outcome and Avoid Complications

摘要

This project suffered a multitude of problems/challenges and as a result is approximately two years behind in operation. The key initial requirement was to modify the existing DCI-approved protocol to meet the provisions of the Telemedicine study. After review of the amendments, DCI felt that the changes were of a magnitude which necessitated an entirely new protocol submission. The new protocol and consent form went through a complete approval process including committee appearances, requested revisions and sample size recalculation. Some of the other requirements of the project could be pursued at the same time as the approval process was underway: most could not e.g., staff could not be hired prior to approval being imminent, space could not be acquired until it was ready to be used. Acquiring staff was difficult as well, and chart reviews and eligibility determinations awaited staff. As of May 2001, the first patient was enrolled into the pilot portion of the project. The pilot portion of the project will enroll and monitor 8 patients separately from the main population of 400. The official start of the one- year project starts once the 400 patient population is enrolled into the project.