Abstract Body: Background: Delirium is a common and severe complication in hospitalized older adults, including those with cerebrovascular disease. In stroke patients, in-hospital delirium accelerates cognitive decline, increases hospital readmissions, and raises early mortality risk.
Objective and Population: This 5-year PCORI-funded trial aims to evaluates the comparative effectiveness of a multi-modal sleep hygiene bundle (MMSH) versus standard of care delirium screening and prevention protocol (SOC-DSPP) in reducing the incidence and burden of delirium among hospitalized older adults (≥ 70 years). MMSH bundle patients will continue to receive SOC-DSPP.
Intervention and Comparator: The MMSH bundle targets five domains: noise reduction, light regulation, moderated staff-patient interaction, safe promotion of daytime mobility, and monitoring of deliriogenic medications (Fig 1). The SOC-DSPP includes twice-daily delirium monitoring, delirium prevalance dashboards, and electronic medical record based alerts for deliriogenic medications. A sub-chort will be ernolled in an actigraphy sub-study for measuring mechanistic effects of MMSH. Wrist worn actigraphy monitors will be used to collect detailed sleep data among control and internvtion patients.
Outcomes: The primary outcome is incident or hospital-acquired delirium in patients who were delirium-free upon admission, assessed twice daily using the 4AT scale by trained nursing and research staff. Secondary outcomes include the Delirium Burden Index (DBI), resolution of delirium present on admission, 4AT positivity rates, adherence to the MMSH bundle, and actigraphy data.
Design: The study uses a pragmatic, Type 2 hybrid effectiveness and implementation design with a stepped wedge cluster randomized trial across 11 acute care units in four hospitals, representing both large teaching and smaller community settings (Fig 2). A minimum of 10,890 patients will be enrolled, providing 90% power to detect a 33% reduction in incident delirium. This sample provides > 80% power for other outcomes. Multiple levels of patient and stakeholder input is incopriated in design and implementation.
Trial Progress: PCORI contracts are signed, and IRB approval has been granted. Recruitment began on July 1, 2024, across all 11 units. The first units will transition to the intervention phase in December 2024. Current demographic and clinical characteristics of enrolled patients will be presented.