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NCT Number: NCT07840560

Sleep Harmonization Via Bundled Team-Based Interventions in the ICU

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.

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Key information

Conditions

Sleep Deprivation Bundle Care Confusion Critical Illness Delirium Disease Attributes Dyssomnias Implementation Science Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Sleep-Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Puerto Rico, Medical Sciences Campus, San Juan, Puerto Rico

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 years or older
  • Present in participating ICU

Exclusion criteria

  • Age less than 18 years
  • Present in ICU less than 1 night

Treatment and study plan

Nighttime noise & light reduction

Behavioral

Nighttime noise and light reduction to promote sleep. Prompted by a single-page bedside checklist.

Clustering patient-care interactions

Behavioral

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.

Other names: Cluster care

Non-pharmacologic sleep aids

Behavioral

Offering non-pharmacologic sleep aids such as earplugs and eye masks. Prompted by a single-page bedside checklist.

Daytime light exposure

Behavioral

Promote daytime wakefulness through light exposure. Prompted by a single-page bedside checklist.

Encourage out-of-bed activity

Behavioral

Promote daytime wakefulness by encouraging out-of-bed activity. Prompted by a single-page bedside checklist.

Medication management to support nighttime sleep

Other

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.

Primary outcomes

  1. Delirium incidence

    Time frame: From ICU admission until first positive CAM-ICU, ICU discharge, or death, whichever comes first, an expected average of 5 days

    Indicator that a patient screens positive on the Confusion Assessment Method for the ICU (CAM-ICU) at any point during their ICU stay. CAM-ICU is performed by ICU nursing staff as part of usual clinical care and abstracted from the health record.

Secondary outcomes

  1. Delirium duration (delirium/coma-free days)

    Time frame: From ICU admission through ICU day 7, ICU discharge, or death, whichever comes first

    Number of days from ICU admission to day 7 on which the patient is alive, CAM-ICU negative, and not in coma. Days alive following ICU discharge are counted as delirium and coma free.

  2. ICU sleep quality (Richards-Campbell Sleep Questionnaire)

    Time frame: Collected up to 7 times per week in the morning (rating the prior night's sleep), from ICU day 2 through ICU discharge or death, an expected average of 5 days

    Patient-reported rating of the previous night's sleep using the Richards-Campbell Sleep Questionnaire (RCSQ). The Richards-Campbell Sleep Questionnaire is a six-item visual analog scale along 100mm lines, the first five items relating to sleep quality and an optional sixth item relating to ICU noise. Each item is scored 0 to 100 and the first five of the items are averaged for a total score ranging from 0 to 100. Higher scores indicate better sleep quality. The Richards-Campbell Sleep Questionnaire is not completed for patients comatose overnight. Proxy completion by nursing staff is recorded and identified as such.

  3. Overall ICU sleep quality (Sleep in the ICU Questionnaire)

    Time frame: Once, within 48 hours after ICU discharge and before hospital discharge, an expected average of 10 days after ICU admission

    One-time patient-reported rating of sleep quality across the entire ICU stay using the Sleep in the ICU Questionnaire (SICUQ), administered after ICU downgrade and before hospital discharge. The Sleep in the Intensive Care Unit Questionnaire uses items rated on a 1 to 10 numeric scale. For sleep quality items, higher scores indicate better sleep quality. For sleep disruption items, higher scores indicate more sleep disruption.

  4. ICU Length of Stay

    Time frame: From the time of ICU admission to the time of ICU discharge or death, an expected average of 5 days

    Length of stay in the ICU, calculated from the times of ICU arrival and ICU downgrade or death.

Other outcomes

  1. Caregiver-reported sleep quality

    Time frame: Once, before hospital discharge, an expected average of 10 days after ICU admission

    Exploratory caregiver-reported measures using a modified Numeric Rating Scale for Sleep (NRS-Sleep). The Numeric Rating Scale for Sleep is a single-item rating of sleep quality on a scale of 0 to 10, with higher scores indicating better sleep quality.

  2. Caregiver sleep experience

    Time frame: Once, before hospital discharge, an expected average of 10 days after ICU admission

    Exploratory caregiver-reported sleep experience using a modified Daily Use Caregiver Sleep Survey (DUCSS). The Daily Use Caregiver Sleep Survey mixes numerical responses with ordinal scales. Numerical items include questions such as asking for the time the participant went to bed and the number of hours of sleep. Other questions are scored on ordinal scales of 1-2, 1-3, and 1-5, with higher scores indicating lower sleep quality or higher sleep impairment.

  3. Family satisfaction with ICU care

    Time frame: Once, before hospital discharge, an expected average of 10 days after ICU admission

    Exploratory family-reported satisfaction using a modified Family Satisfaction with Care in the Intensive Care Unit questionnaire (FS-ICU-24R). A family member rates their satisfaction with the patient's care in the ICU. Five-point Likert scale responses are transformed to a 0 to 100 percentage scale, with higher scores indicating greater satisfaction.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • AdventHealth Orlando
  • Baylor University
  • Johns Hopkins University
  • Massachusetts General Hospital
  • Patient-Centered Outcomes Research Institute
  • University of California, San Francisco
  • University of Puerto Rico
  • University of Utah
  • Vanderbilt University Medical Center

Registry information

Official study title

Comparing Two Multicomponent ICU Bundles To Promote Sleep and Reduce Delirium in Critically Ill Adults

Acronym: SHANTI-ICU

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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