Sleep Harmonization Via Bundled Team-Based Interventions in the ICU

DESIGN SHANTI-ICU is a pragmatic, hybrid type I effectiveness-implementation study using a concurrent multiple-intervention stepped wedge randomized design. The unit of randomization is the hospital, not the individual patient. Eight hospitals, i.e. "clusters" with two ICUs per hospital, will be randomized to Bundle A or Bundle B, and to the time at which they cross over from usual care. All clusters begin in a usual care preparation period consisting of 9 to 18 months, cross over in one of 4 steps with 3 months between each step, and remain in the implementation period consisting of 24 to 33 months. An evaluation phase follows implementation. SETTING AND POPULATION Participating hospitals span academic, community, safety-net, and resource-limited settings. Based on historical census at the participating hospitals, approximately 62,500 adult ICU admissions are anticipated across the preparation and implementation phases. INTERVENTIONS Bundle A is an evidence-based, multicomponent, non-pharmacologic sleep promotion strategy. Bundle A includes reducing nighttime noise and light, clustering patient care interactions, offering non-pharmacologic sleep aids such as earplugs and eye masks, and promoting daytime wakefulness through light exposure and out-of-bed activity. Bundle B includes Bundle A plus pharmacist-led pharmacologic strategies. These include deprescribing medications known to disrupt sleep, optimizing the timing of medication administration, and selective use of sleep-promoting agents (e.g., melatonin, dexmedetomidine). ANALYSIS Analyses will compare patient-level delirium incidence and secondary outcomes before and after bundle implementation, and between Bundle A and Bundle B, using regression models appropriate to a stepped wedge design which account for clustering of patients within the hospital and ICU. Pre-specified subgroups include age, race and ethnicity, and ICU type. IMPLEMENTATION EVALUATION Bundle A and B implementation will be evaluated continuously. The investigators will assess how consistently each bundle is delivered, what helps and what gets in the way of adoption at the bedside, and whether the bundles are sustained over time. Evaluation will draw on sources such as bundle checklist data, interviews with clinicians and stakeholders, and site process observations, and will be guided by established implementation science frameworks such as the Consolidated Framework for Implementation Research (CFIR) and RE-AIM.