Sleep Harmonization Via Bundled Team-Based Interventions in the ICU
SHANTI-ICU
Comparing Two Multicomponent ICU Bundles To Promote Sleep and Reduce Delirium in Critically Ill Adults
3 other identifiers
interventional
62,500
2 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2026
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2026
CompletedFirst Posted
Study publicly available on registry
September 25, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2031
September 25, 2026
September 1, 2026
3.5 years
August 20, 2026
September 21, 2026
Conditions
Keywords
Outcome Measures
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.
From ICU admission until first positive CAM-ICU, ICU discharge, or death, whichever comes first, an expected average of 5 days
Secondary Outcomes (4)
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
Other Outcomes (3)
Caregiver-reported sleep quality
Once, before hospital discharge, an expected average of 10 days after ICU admission
Caregiver sleep experience
Once, before hospital discharge, an expected average of 10 days after ICU admission
Family satisfaction with ICU care
Once, before hospital discharge, an expected average of 10 days after ICU admission
Study Arms (3)
Usual Care
NO INTERVENTIONPeriod 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
ACTIVE COMPARATORMulticomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care.
Bundle B
ACTIVE COMPARATORAll components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.
Interventions
Nighttime noise and light reduction to promote sleep. Prompted by a single-page bedside checklist.
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.
Offering non-pharmacologic sleep aids such as earplugs and eye masks. Prompted by a single-page bedside checklist.
Promote daytime wakefulness through light exposure. Prompted by a single-page bedside checklist.
Promote daytime wakefulness by encouraging out-of-bed activity. Prompted by a single-page bedside checklist.
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.
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Present in participating ICU
You may not qualify if:
- Age less than 18 years
- Present in ICU less than 1 night
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, San Diegolead
- Johns Hopkins Universitycollaborator
- University of California, San Franciscocollaborator
- University of Utahcollaborator
- Vanderbilt University Medical Centercollaborator
- University of Puerto Ricocollaborator
- Baylor Universitycollaborator
- Massachusetts General Hospitalcollaborator
- AdventHealth Orlandocollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (8)
University of California San Diego Health
La Jolla, California, 92093, United States
University of California San Francisco Medical Center
San Francisco, California, 94143, United States
AdventHealth Orlando
Orlando, Florida, 32803, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Utah Health
Salt Lake City, Utah, 84132, United States
University of Puerto Rico, Medical Sciences Campus
San Juan, 00936, Puerto Rico
Related Publications (15)
Knauert MP, Ayas NT, Bosma KJ, Drouot X, Heavner MS, Owens RL, Watson PL, Wilcox ME, Anderson BJ, Cordoza ML, Devlin JW, Elliott R, Gehlbach BK, Girard TD, Kamdar BB, Korwin AS, Lusczek ER, Parthasarathy S, Spies C, Sunderram J, Telias I, Weinhouse GL, Zee PC. Causes, Consequences, and Treatments of Sleep and Circadian Disruption in the ICU: An Official American Thoracic Society Research Statement. Am J Respir Crit Care Med. 2023 Apr 1;207(7):e49-e68. doi: 10.1164/rccm.202301-0184ST.
PMID: 36999950BACKGROUNDBuysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PMID: 2748771BACKGROUNDRood P, Frenzel T, Verhage R, Bonn M, van der Hoeven H, Pickkers P, van den Boogaard M. Development and daily use of a numeric rating score to assess sleep quality in ICU patients. J Crit Care. 2019 Aug;52:68-74. doi: 10.1016/j.jcrc.2019.04.009. Epub 2019 Apr 6.
PMID: 30981928BACKGROUNDFreedman NS, Kotzer N, Schwab RJ. Patient perception of sleep quality and etiology of sleep disruption in the intensive care unit. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1155-62. doi: 10.1164/ajrccm.159.4.9806141.
PMID: 10194160BACKGROUNDAndrews JL, Louzon PR, Torres X, Pyles E, Ali MH, Du Y, Devlin JW. Impact of a Pharmacist-Led Intensive Care Unit Sleep Improvement Protocol on Sleep Duration and Quality. Ann Pharmacother. 2021 Jul;55(7):863-869. doi: 10.1177/1060028020973198. Epub 2020 Nov 9.
PMID: 33166192BACKGROUNDKamdar BB, Niessen T, Colantuoni E, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Collop NA, Needham DM. Delirium transitions in the medical ICU: exploring the role of sleep quality and other factors. Crit Care Med. 2015 Jan;43(1):135-141. doi: 10.1097/CCM.0000000000000610.
PMID: 25230376BACKGROUNDKamdar BB, Shah PA, King LM, Kho ME, Zhou X, Colantuoni E, Collop NA, Needham DM. Patient-nurse interrater reliability and agreement of the Richards-Campbell sleep questionnaire. Am J Crit Care. 2012 Jul;21(4):261-9. doi: 10.4037/ajcc2012111.
PMID: 22751369BACKGROUNDKamdar BB, Combs MP, Colantuoni E, King LM, Niessen T, Neufeld KJ, Collop NA, Needham DM. The association of sleep quality, delirium, and sedation status with daily participation in physical therapy in the ICU. Crit Care. 2016 Aug 18;19:261. doi: 10.1186/s13054-016-1433-z.
PMID: 27538536BACKGROUNDKamdar BB, Yang J, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Brower RG, Collop NA, Needham DM. Developing, implementing, and evaluating a multifaceted quality improvement intervention to promote sleep in an ICU. Am J Med Qual. 2014 Nov-Dec;29(6):546-54. doi: 10.1177/1062860613509684. Epub 2013 Nov 22.
PMID: 24270169BACKGROUNDKamdar BB, King LM, Collop NA, Sakamuri S, Colantuoni E, Neufeld KJ, Bienvenu OJ, Rowden AM, Touradji P, Brower RG, Needham DM. The effect of a quality improvement intervention on perceived sleep quality and cognition in a medical ICU. Crit Care Med. 2013 Mar;41(3):800-9. doi: 10.1097/CCM.0b013e3182746442.
PMID: 23314584BACKGROUNDNicolas A, Aizpitarte E, Iruarrizaga A, Vazquez M, Margall A, Asiain C. Perception of night-time sleep by surgical patients in an intensive care unit. Nurs Crit Care. 2008 Jan-Feb;13(1):25-33. doi: 10.1111/j.1478-5153.2007.00255.x.
PMID: 18226052BACKGROUNDRichards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
PMID: 11227580BACKGROUNDDevlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.
PMID: 30113379BACKGROUNDCordoza M, Kamdar BB, Gorecki NM, Heavner MS. Promoting Sleep in Acute and Critically Ill Adults: Enhancing Recovery Through Evidence-Based Practices. Crit Care Nurse. 2026 Jun 1;46(3):e1-e9. doi: 10.4037/ccn2026191. No abstract available.
PMID: 42219197BACKGROUNDKamdar BB, Needham DM, Collop NA. Sleep deprivation in critical illness: its role in physical and psychological recovery. J Intensive Care Med. 2012 Mar-Apr;27(2):97-111. doi: 10.1177/0885066610394322. Epub 2011 Jan 10.
PMID: 21220271BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Biren B Kamdar, MD, MBA, MHS
University of California, San Diego
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 20, 2026
First Posted
September 25, 2026
Study Start
October 1, 2026
Primary Completion (Estimated)
April 1, 2030
Study Completion (Estimated)
March 1, 2031
Last Updated
September 25, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Following study closeout, per PCORI award terms
- Access Criteria
- Controlled access via the PCORI Data Repository at ICPSR, subject to that repository's data use terms
As a condition of the PCORI award, a de-identified full data package will be deposited into the PCORI Data Repository (PCODR) at the Inter-university Consortium for Political and Social Research (ICPSR) as a controlled-access dataset following study closeout.