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Sleep Harmonization Via Bundled Team-Based Interventions in the ICU

ConditionsSleep DeprivationCritical IllnessSleep-Wake DisordersBundle CareImplementation ScienceDelirium
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Diego

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older

Present in participating ICU

Disqualifiers

Age less than 18 years

Present in ICU less than 1 night

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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 intervention

    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.

Treatment groups

62,500 Participants
are divided into 3 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: Bundle AActive comparator 5 interventions
Group C: Bundle BActive comparator 6 interventions

Trial outcomes

Primary outcomes

1

Delirium incidence

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.

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

Secondary outcomes

1

Delirium duration (delirium/coma-free days)

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.

Time frame
From ICU admission through ICU day 7, ICU discharge, or death, whichever comes first
2

ICU sleep quality (Richards-Campbell Sleep Questionnaire)

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.

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
3

Overall ICU sleep quality (Sleep in the ICU Questionnaire)

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.

Time frame
Once, within 48 hours after ICU discharge and before hospital discharge, an expected average of 10 days after ICU admission
4

ICU Length of Stay

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

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

Other outcomes

1

Caregiver-reported sleep quality

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.

Time frame
Once, before hospital discharge, an expected average of 10 days after ICU admission
2

Caregiver sleep experience

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.

Time frame
Once, before hospital discharge, an expected average of 10 days after ICU admission
3

Family satisfaction with ICU care

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.

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Diego

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Johns Hopkins University

Collaborator

Massachusetts General Hospital

Collaborator

University of California, San Francisco

Collaborator

University of Utah

Collaborator

Vanderbilt University Medical Center

Collaborator

University of Puerto Rico

Collaborator

AdventHealth Orlando

Collaborator

Baylor University

Collaborator

Source ClinicalTrials.gov

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