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Background Delirium after acute stroke is a serious complication. Numerous studies support a benefit of multicomponent interventions in minimizing delirium-related complications in at-risk patients, but this has not been reported in acute stroke patients. The purpose of this study was to explore the feasibility of conducting a randomized (delirium care) versus usual standardized stroke care (usual care) in reducing delirium in acute stroke. Objective This pilot study assessed the feasibility of (1) enrollment within the 48-hour window when delirium risk is greatest, (2) measuring cognitive function using the Montreal Cognitive Assessment, (3) delivering interventions 7 days per week, and (4) determining delirium incidence in stroke-related cognitive dysfunction. Methods A 2-group randomized controlled trial was conducted. Patients admitted with ischemic and hemorrhagic strokes and 50 years or older, English speaking, and without delirium on admit were recruited, consented, and randomized to usual care or delirium care groups. Results Data from 125 subjects (delirium care, n = 59; usual care, n = 66) were analyzed. All Montreal Cognitive Assessment subscales were completed by 86% of subjects (delirium care, mean [SD], 18.14 [6.03]; usual care, mean [SD], 17.61 [6.29]). Subjects in the delirium care group received a mean of 6.10 therapeutic activities (range, 2-23) and daily medication review by a clinical pharmacist using anticholinergic drug calculations. Delirium incidence was 8% (10/125), 3 in the delirium care group and 7 in the usual care group. Conclusion Findings support the feasibility of delivering a multicomponent delirium prevention intervention in acute stroke and warrants testing intervention effects on delirium outcomes and anticholinergic medication administration.

Delirium in acute stroke has higher morbidity and mortality than those without delirium. This two-group randomized controlled trial (RCT) tests if a multicomponent intervention improves delirium outcomes in stroke patients at a comprehensive stroke center. This presentation describes the challenges in managing a RCT in acute stroke. Scientific rigor requires coordinating staff, enrolling adequate sample size, assuring intervention fidelity, and fostering data integrity. A sample of 282 subjects is required for 80% power (α=0.05) to determine a 10% reduction in incident delirium. Eligibility includes acute stroke, aged ≥ 50 years, no aphasia or delirium on admit. Subjects randomized to Usual Care (UC) or Delirium Care (DC). Both groups receive standardized Stroke Care. DC subjects receive a multicomponent intervention: 1) pharmacist recommendations using Anticholinergic Drug scale scores; and 2) therapeutic activities. NIHSS, Montreal Cognitive Assessment (MoCA), Confusion Assessment Method (CAM), and mRS are used to determine primary (delirium) and secondary endpoints (LOS, neurological deficit, functional status). A total of 513 patients screened over 289 consecutive days required unbudgeted staff. The 310 excluded [aphasia (94), baseline delirium (36), critically ill (92), LOS