Effect of computer-aided management on the quality of treatment in anticoagulated patients: a prospective, randomized, multicenter trial of APROAT (Automated PRogram for Oral Anticoagulant Treatment)

Background and Objectives. We carded out a prospective, randomized trial to test whether a computer-based decision support system to initiate and main tain oral anticoagulant (OA) treatment can improve the laboratory quality o f therapy. Design and Methods. Two separate sets of patients on oral anticoagulants, i n five Italian anticoagulant clinics, were studied: 335 patients in the fir st three months of treatment (stabilization phase), 916 patients (775 patie nt-years) beyond the third month of treatment (maintenance phase). Patents were randomized to a computerized system, which included algorithms able to suggest OA dosing and to schedule appointments (computer-aided dosing) or to an arm in which OA were prescribed by the same teams of expert physician s without such algorithms (control group). Primary outcomes were: A) the pe rcentage of patients reaching a stable state of anticoagulation during each of the first three months of treatment; B) the percentage of time individu als spent Within the aimed therapeutic range (maintenance phase). Results. Patients in the computer-aided dosing group achieved a stable stat e significantly faster (p <0.01) and they spent more time within the therap eutic range during maintenance (p <0.001) than controls. The favorable effe ct of computer-aided dosing was mainly due to a reduction of the time spent below the therapeutic range and was associated with an increase of mean IN R value, of anticoagulant drug dosage, and with a reduction of the number o f appointments per patient (all changes significant p <0.001). Interpretation and Conclusions. The computer decision-aided support improve s the laboratory quality of anticoagulant treatment, both during long-term maintenance and in the early, highly unstable phase of treatment, and it al so significantly reduces the number Of Scheduled laboratory controls. (C) 2 001, Fenrata Storti Foundation.