OPTIMISTmain (Optimal Post Tpa-Iv Monitoring in Ischemic Stroke) is an international trial comparing the impact of different intensities of nursing care monitoring for acute ischemic stroke patients who have received treatment with recombinant tissue plasminogen activator (rtPA). When conducted in a timely manner, treatment with rtPA can offer acute ischemic stroke patients a life without major disability.
Treatment with rtPA requires a high-intensity schedule of vital sign and neurologic assessments, which usually necessitates a 1:2 nurse-patient ratio and admission to an intensive care unit or similar ward for at least 24 hours. However, studies have indicated that patients with mild neurologic deficits after rtPA therapy do not actually require such intense monitoring. In fact, it is possible that the benefits of such intense monitoring could be offset by the effects of the nurses’ interruptions to patients’ rest and sleep, resulting in an increase in delirium, falls, and delayed recovery. OPTIMISTmain seeks to find out if current practice guidelines truly are the best practice for patients with mild neurologic deficits after treatment with rtPA.
OPTIMISTmain is an international, multicenter, stepped wedge cluster, randomized, controlled trial. The study plans to enroll 7,200 participants across 120 sites in the US, Australia, and other potential countries. Genentech, Johns Hopkins University, and The George Institute for Global Health in Australia are collaborating on the project. It is funded by a program grant from the National Health and Medical Research Council of Australia and University of New South Wales, Genentech, and participating countries/regions. BIOS CTCC will serve as the clinical coordinating center.
ClinicalTrials.gov Identifier: NCT03734640