Background: Though there is a demonstrated beneficial effect of a Care Bundle for acute spontaneous intracerebral hemorrhage (ICH), uncertainty remains about the effectiveness of particular components of the Care Bundle and their applicability to Australia and other countries.
Aim: To determine the effectiveness of implementing a Care Bundle that involves the rapid correction of abnormal physiological variables and referral pathways versus usual care on functional recovery defined by utility-weighted modified Rankin scale (UW-mRS) scores for patients with acute ICH.
Methods: An international, multicenter, batched, parallel, cluster, randomized clinical trial with a focus on implementation and quality improvement. Adults with ICH admitted to a hospital ≤24 hours of symptom onset will receive either Care Bundle with time- and target-based metrics including early physiological control (intensive blood pressure lowering, glycemic control, and treatment of pyrexia), reversal of anticoagulation, avoidance of do-not-resuscitate orders, and referral pathways for intensive care and neurosurgery, or usual care. In each batch, hospitals are randomized into two groups according to the timing of the intervention over three phases (baseline/usual care, randomized evaluation, and post-implementation follow-up). Both clinical (i.e. UW-mRS, mortality, and quality of life at 6 months) and implementation (i.e. fidelity, feasibility, and sustainability) outcomes will be evaluated. A total of 3500 ICH patients from 110 hospitals will provide 90% power (α=0.05) to detect a plausibly larger effect size of 0.20.
Discussion: I-CATCHER aims to provide solid evidence and bring changes to clinical practice by integrating the Care Bundle as part of well-organised multidisciplinary care in stroke settings.