The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) Trial: The Value of Wireless Remote Monitoring With Automatic Clinician Alerts

Abstract

The primary objective was to determine if wireless remote monitoring with automatic clinician alerts reduces the time from a clinical event to a clinical decision in response to arrhythmias, cardiovascular (CV) disease progression, and device issues compared to patients receiving standard in-office care. A secondary objective was to compare the rates of CV health care utilization between patients in the remote and in-office arms. In addition to providing life-saving therapy, implantable cardioverter-defibrillators collect advanced diagnostics on the progression of the patient's heart disease. Device technology has progressed to allow wireless remote monitoring with automatic clinician alerts to replace some scheduled in-office visits. The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) study was a multicenter, prospective, randomized evaluation involving 1,997 patients from 136 clinical sites who underwent insertion of an implantable cardioverter-defibrillator (including cardiac resynchronization therapy devices) and were followed up for 15 months. Health care utilization data included all CV-related hospitalizations, emergency department visits, and clinic office visits. The median time from clinical event to clinical decision per patient was reduced from 22 days in the in-office arm to 4.6 days in the remote arm (p < 0.001). The health care utilization data revealed a decrease in mean length of stay per CV hospitalization visit from 4.0 days in the in-office arm to 3.3 days in the remote arm (p = 0.002). Wireless remote monitoring with automatic clinician alerts as compared with standard in-office follow-up significantly reduced the time to a clinical decision in response to clinical events and was associated with a significant reduction in mean length of CV hospital stay. (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision [CONNECT]; NCT00402246).