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Sleep Harmonization Via Bundled Team-Based Interventions in the ICU
Sponsor: University of California, San Diego
Summary
SHANTI-ICU compares the effectiveness of two evidence-based multicomponent ICU sleep promotion bundles on delirium and patient-reported sleep quality in critically ill adults. Bundle A is a non-pharmacologic strategy. Bundle B includes all components of Bundle A plus pharmacist-led pharmacologic strategies. Sixteen intensive care units across eight hospitals implement one of the two bundles as a unit-level change to routine care, using a concurrent multiple-intervention stepped wedge randomized design. The primary outcome is delirium incidence, measured using the Confusion Assessment Method for the ICU (CAM-ICU) as documented during routine clinical care. Secondary outcomes are delirium duration, ICU length of stay, nightly patient-reported sleep quality, and overall patient-reported ICU sleep quality. Patients receive the assigned bundle as part of routine care. The study operates under an IRB-approved waiver of informed consent and waiver of HIPAA authorization; there is no individual enrollment procedure.
Official title: Comparing Two Multicomponent ICU Bundles To Promote Sleep and Reduce Delirium in Critically Ill Adults
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
62500
Start Date
2026-10-01
Completion Date
2031-03
Last Updated
2026-09-25
Healthy Volunteers
No
Conditions
Interventions
Nighttime noise & light reduction
Nighttime noise and light reduction to promote sleep. Prompted by a single-page bedside checklist.
Clustering patient-care interactions
Clustering patient-care interactions when possible, to reduce the number of times the patient is awakened during the night. Prompted by a single-page bedside checklist.
Non-pharmacologic sleep aids
Offering non-pharmacologic sleep aids such as earplugs and eye masks. Prompted by a single-page bedside checklist.
Daytime light exposure
Promote daytime wakefulness through light exposure. Prompted by a single-page bedside checklist.
Encourage out-of-bed activity
Promote daytime wakefulness by encouraging out-of-bed activity. Prompted by a single-page bedside checklist.
Medication management to support nighttime sleep
Pharmacist conducts a medication review and makes recommendations related to deprescribing of medications known to disrupt sleep, optimization of medication administration timing, and selective use of sleep-promoting agents such as melatonin and dexmedetomidine when clinically appropriate. No specific medications will be given to all patients, only those recommended by the pharmacist to support sleep for that specific patient after careful review.
Locations (8)
University of California San Diego Health
La Jolla, California, United States
University of California San Francisco Medical Center
San Francisco, California, United States
AdventHealth Orlando
Orlando, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
University of Puerto Rico, Medical Sciences Campus
San Juan, Puerto Rico