[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657688":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":49,"studyPopulation":46,"armGroups":50,"interventions":70,"overallOfficials":98,"centralContacts":102,"locations":111,"responsibleParty":245,"collaborators":248,"id":265,"slug":266,"hasResults":267,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":267,"sex":273,"minAge":274,"maxAge":46,"enrollmentInfo":275,"targetDuration":46,"studyType":278,"phases":279,"briefSummary":281,"conditions":282,"keywords":289,"overallStatus":299,"whyStopped":46,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":309},{"fullName":5,"class":6},"University of California, San Diego","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,18,22,26],{"measure":15,"description":16,"timeFrame":17},"Delirium duration (delirium\u002Fcoma-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.","From ICU admission through ICU day 7, ICU discharge, or death, whichever comes first",{"measure":19,"description":20,"timeFrame":21},"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.","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",{"measure":23,"description":24,"timeFrame":25},"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.","Once, within 48 hours after ICU discharge and before hospital discharge, an expected average of 10 days after ICU admission",{"measure":27,"description":28,"timeFrame":29},"ICU Length of Stay","Length of stay in the ICU, calculated from the times of ICU arrival and ICU downgrade or death.","From the time of ICU admission to the time of ICU discharge or death, an expected average of 5 days",[31,35,38],{"measure":32,"description":33,"timeFrame":34},"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.","Once, before hospital discharge, an expected average of 10 days after ICU admission",{"measure":36,"description":37,"timeFrame":34},"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.",{"measure":39,"description":40,"timeFrame":34},"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.",{"allocation":42,"interventionModel":43,"interventionModelDescription":44,"primaryPurpose":45,"observationalModel":46,"timePerspective":46,"maskingInfo":47},"RANDOMIZED","PARALLEL","Concurrent multiple-intervention stepped wedge cluster randomized design. Eight hospitals, with two ICUs per hospital, are randomized to Bundle A or Bundle B and to the time at which they cross over from usual care. Randomization is at the level of the hospital, not the patient.","HEALTH_SERVICES_RESEARCH",null,{"masking":48,"maskingDescription":46,"whoMasked":46},"NONE","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.\n\nAll 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.\n\nSETTING 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.\n\nINTERVENTIONS 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.\n\nBundle 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).\n\nANALYSIS 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.\n\nIMPLEMENTATION 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.",[51,55,65],{"label":52,"type":53,"description":54,"interventionNames":46},"Usual Care","NO_INTERVENTION","Period prior to cluster crossover. Hospitals\u002FICUs 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.",{"label":56,"type":57,"description":58,"interventionNames":59},"Bundle A","ACTIVE_COMPARATOR","Multicomponent non-pharmacologic ICU sleep promotion bundle delivered as a unit-level change to routine care.",[60,61,62,63,64],"Behavioral: Nighttime noise & light reduction","Behavioral: Clustering patient-care interactions","Behavioral: Non-pharmacologic sleep aids","Behavioral: Daytime light exposure","Behavioral: Encourage out-of-bed activity",{"label":66,"type":57,"description":67,"interventionNames":68},"Bundle B","All components of Bundle A plus pharmacist-led pharmacologic sleep promotion strategies, delivered as a unit-level change to routine care.",[60,61,62,63,64,69],"Other: Medication management to support nighttime sleep",[71,76,82,86,90,94],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":46},"BEHAVIORAL","Nighttime noise & light reduction","Nighttime noise and light reduction to promote sleep. Prompted by a single-page bedside checklist.",[56,66],{"type":72,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"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.",[56,66],[81],"Cluster care",{"type":72,"name":83,"description":84,"armGroupLabels":85,"otherNames":46},"Non-pharmacologic sleep aids","Offering non-pharmacologic sleep aids such as earplugs and eye masks. Prompted by a single-page bedside checklist.",[56,66],{"type":72,"name":87,"description":88,"armGroupLabels":89,"otherNames":46},"Daytime light exposure","Promote daytime wakefulness through light exposure. Prompted by a single-page bedside checklist.",[56,66],{"type":72,"name":91,"description":92,"armGroupLabels":93,"otherNames":46},"Encourage out-of-bed activity","Promote daytime wakefulness by encouraging out-of-bed activity. Prompted by a single-page bedside checklist.",[56,66],{"type":6,"name":95,"description":96,"armGroupLabels":97,"otherNames":46},"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.",[66],[99],{"name":100,"affiliation":5,"role":101},"Biren B Kamdar, MD, MBA, MHS","PRINCIPAL_INVESTIGATOR",[103,107],{"name":100,"role":104,"phone":105,"phoneExt":46,"email":106},"CONTACT","818-465-8575","bkamdar@health.ucsd.edu",{"name":108,"role":104,"phone":109,"phoneExt":46,"email":110},"Janelle M Fine, BS","858-534-8199","jfine@health.ucsd.edu",[112,130,145,161,177,196,212,228],{"facility":113,"status":46,"city":114,"state":115,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":124,"contacts":125},"University of California San Diego Health","La Jolla","California","92093","United States","US",{"type":120,"coordinates":121},"Point",[122,123],-117.2742,32.84727,{"lat":123,"lon":122},[126,128,129],{"name":100,"role":104,"phone":127,"phoneExt":46,"email":106},"818-465-8475",{"name":108,"role":104,"phone":109,"phoneExt":46,"email":110},{"name":100,"role":101,"phone":46,"phoneExt":46,"email":46},{"facility":131,"status":46,"city":132,"state":115,"zip":133,"country":117,"countryCode":118,"cosmosGeoPoint":134,"geoPoint":138,"contacts":139},"University of California San Francisco Medical Center","San Francisco","94143",{"type":120,"coordinates":135},[136,137],-122.41942,37.77493,{"lat":137,"lon":136},[140,144],{"name":141,"role":104,"phone":142,"phoneExt":46,"email":143},"Rima Bouajram, PharmD","415-476-1000","rima.bouajram@ucsf.edu",{"name":141,"role":101,"phone":46,"phoneExt":46,"email":46},{"facility":146,"status":46,"city":147,"state":148,"zip":149,"country":117,"countryCode":118,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"AdventHealth Orlando","Orlando","Florida","32803",{"type":120,"coordinates":151},[152,153],-81.37924,28.53834,{"lat":153,"lon":152},[156,160],{"name":157,"role":104,"phone":158,"phoneExt":46,"email":159},"Patricia Louzon, PharmD","407-303-5600","Patricia.Louzon@AdventHealth.com",{"name":157,"role":101,"phone":46,"phoneExt":46,"email":46},{"facility":162,"status":46,"city":163,"state":164,"zip":165,"country":117,"countryCode":118,"cosmosGeoPoint":166,"geoPoint":170,"contacts":171},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":120,"coordinates":167},[168,169],-71.05977,42.35843,{"lat":169,"lon":168},[172,176],{"name":173,"role":104,"phone":174,"phoneExt":46,"email":175},"Lorenzo Berra, MD","617-278-1000","lberra@mgh.harvard.edu",{"name":173,"role":101,"phone":46,"phoneExt":46,"email":46},{"facility":178,"status":46,"city":179,"state":180,"zip":181,"country":117,"countryCode":118,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Vanderbilt University Medical Center","Nashville","Tennessee","37232",{"type":120,"coordinates":183},[184,185],-86.78444,36.16589,{"lat":185,"lon":184},[188,192,195],{"name":189,"role":104,"phone":190,"phoneExt":46,"email":191},"E. Wesley Ely, MD, MPH","615-322-4967","wes.ely@vumc.org",{"name":193,"role":104,"phone":46,"phoneExt":46,"email":194},"Makayla Cordoza, PhD, RN","makayla.cordoza@vanderbilt.edu",{"name":189,"role":101,"phone":46,"phoneExt":46,"email":46},{"facility":197,"status":46,"city":198,"state":199,"zip":200,"country":117,"countryCode":118,"cosmosGeoPoint":201,"geoPoint":205,"contacts":206},"Baylor University Medical Center","Dallas","Texas","75246",{"type":120,"coordinates":202},[203,204],-96.80667,32.78306,{"lat":204,"lon":203},[207,211],{"name":208,"role":104,"phone":209,"phoneExt":46,"email":210},"Nicole Gorecki, DNP","214-820-0111","nicole_gorecki@baylor.edu",{"name":208,"role":101,"phone":46,"phoneExt":46,"email":46},{"facility":213,"status":46,"city":214,"state":215,"zip":216,"country":117,"countryCode":118,"cosmosGeoPoint":217,"geoPoint":221,"contacts":222},"University of Utah Health","Salt Lake City","Utah","84132",{"type":120,"coordinates":218},[219,220],-111.89105,40.76078,{"lat":220,"lon":219},[223,227],{"name":224,"role":104,"phone":225,"phoneExt":46,"email":226},"Joseph Tonna, MD","801-581-2121","joseph.tonna@hsc.utah.edu",{"name":224,"role":101,"phone":46,"phoneExt":46,"email":46},{"facility":229,"status":46,"city":230,"state":46,"zip":231,"country":232,"countryCode":233,"cosmosGeoPoint":234,"geoPoint":238,"contacts":239},"University of Puerto Rico, Medical Sciences Campus","San Juan","00936","Puerto Rico","PR",{"type":120,"coordinates":235},[236,237],-66.10572,18.46633,{"lat":237,"lon":236},[240,244],{"name":241,"role":104,"phone":46,"phoneExt":242,"email":243},"Milagros Figueroa-Ramos, PhD, RN","787-758-2525","milagros.figueroa@upr.edu",{"name":241,"role":101,"phone":46,"phoneExt":46,"email":46},{"type":101,"investigatorFullName":246,"investigatorTitle":247,"investigatorAffiliation":5,"oldNameTitle":46,"oldOrganization":46},"Biren Kamdar","Principal Investigator",[249,251,253,254,256,258,259,261,263],{"name":250,"class":6},"Patient-Centered Outcomes Research Institute",{"name":252,"class":6},"Johns Hopkins University",{"name":162,"class":6},{"name":255,"class":6},"University of California, San Francisco",{"name":257,"class":6},"University of Utah",{"name":178,"class":6},{"name":260,"class":6},"University of Puerto Rico",{"name":146,"class":262},"UNKNOWN",{"name":264,"class":6},"Baylor University","100657688","sleep-harmonization-via-bundled-team-based-interventions-in-the-icu-100657688",false,"NCT07840560","Sleep Harmonization Via Bundled Team-Based Interventions in the ICU","Comparing Two Multicomponent ICU Bundles To Promote Sleep and Reduce Delirium in Critically Ill Adults","SHANTI-ICU","Inclusion Criteria:\n\n* Age 18 years or older\n* Present in participating ICU\n\nExclusion Criteria:\n\n* Age less than 18 years\n* Present in ICU less than 1 night","ALL","18 Years",{"count":276,"type":277},62500,"ESTIMATED","INTERVENTIONAL",[280],"NA","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.\n\nBundle 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.\n\nThe 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.\n\nPatients 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.",[283,284,285,286,287,288],"Sleep Deprivation","Critical Illness","Sleep-Wake Disorders","Bundle Care","Implementation Science","Delirium",[290,291,292,293,294,284,295,296,297,298],"intensive care unit","sleep promotion","delirium prevention","stepped wedge pragmatic clinical trial","implementation science","Critical Care","Patient Care Bundles","Sleep Quality","Pharmacology","NOT_YET_RECRUITING","2026-09-21",{"date":302,"type":303},"2026-09-25","ACTUAL",{"date":305,"type":277},"2026-10-01",{"date":307,"type":277},"2031-03",{"name":5,"class":6},8]