Comparing Two Multicomponent ICU Bundles To Promote Sleep and Reduce Delirium in Critically Ill Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 62,500
- 试验地点
- 8
- 主要终点
- Delirium incidence
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Present in participating ICU
排除标准
- •Age less than 18 years
- •Present in ICU less than 1 night
研究组 & 干预措施
Usual Care
Period prior to cluster crossover. Hospitals/ICUs deliver usual care without a structured sleep promotion bundle. Delirium and sleep outcomes are collected in the same way during this period as during implementation.
Bundle A
Multicomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care.
干预措施: Nighttime noise & light reduction (Behavioral)
Bundle A
Multicomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care.
干预措施: Clustering patient-care interactions (Behavioral)
Bundle A
Multicomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care.
干预措施: Non-pharmacologic sleep aids (Behavioral)
Bundle A
Multicomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care.
干预措施: Daytime light exposure (Behavioral)
Bundle A
Multicomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care.
干预措施: Encourage out-of-bed activity (Behavioral)
Bundle B
All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.
干预措施: Nighttime noise & light reduction (Behavioral)
Bundle B
All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.
干预措施: Clustering patient-care interactions (Behavioral)
Bundle B
All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.
干预措施: Non-pharmacologic sleep aids (Behavioral)
Bundle B
All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.
干预措施: Daytime light exposure (Behavioral)
Bundle B
All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.
干预措施: Encourage out-of-bed activity (Behavioral)
Bundle B
All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.
干预措施: Medication management to support nighttime sleep (Other)
结局指标
主要结局
Delirium incidence
时间窗: 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.
次要结局
- Delirium duration (delirium/coma-free days)(From ICU admission through ICU day 7, ICU discharge, or death, whichever comes first)
- ICU sleep quality (Richards-Campbell Sleep Questionnaire)(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)
- Overall ICU sleep quality (Sleep in the ICU Questionnaire)(Once, within 48 hours after ICU discharge and before hospital discharge, an expected average of 10 days after ICU admission)
- ICU Length of Stay(From the time of ICU admission to the time of ICU discharge or death, an expected average of 5 days)
研究者
Biren Kamdar
Principal Investigator
University of California, San Diego