An interventional study of Realtime audit and feedback and RN Implementation Facilitator in Implementation Science, Delirium and Critical Illness, sponsored by University of Nebraska. Recruiting at 3 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by University of Nebraska · Not applicable, Interventional, and Treatment
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Among 262 studies in Delirium with a site in United States — 37 open to participants now, 59 under way, 7 of them phase 3. Delirium · United States.
Among the 262 studies in Delirium with a site in United States, this one is the 2nd largest by planned enrollment of the 193 interventional ones that give a count, is one of 19 that started in 2024, is one of 104 with no phase, reaches primary completion later than 48 of the 58 other live ones, and was the 229th registered.
933 studies on the registry are indexed under Delirium; 189 are open to participants now.
Browse Delirium studies →37 of the 262 studies in Delirium with a site in United States are open now. Recruiting first, the newest first:
The Methodist Hospital Research Institute · Sites in United States
Ages up to 65
Northwestern University · Sites in United States
Ages 18+
Ceribell Inc. · Sites in United States
Ages 18+
Washington University School of Medicine · Sites in United States
Ages 60+
Indiana University · Sites in United States
Ages 50+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 127 Delirium studies recruiting now, 99 (78%) set no upper age limit and 8 (6%) stop at 75 or younger; 8 take children under 18; 15 take healthy volunteers.
This study: 19 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
262 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 32 · Phase 3 25 · Phase 4 32
First in 2000; this study’s year is marked. 19 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 16,500 is above the median of 112 across 550 interventional studies indexed under Delirium.
Median enrollment 87 across the 193 interventional studies, 124 across the 69 observational. Of the 171 that completed or were terminated, 67 (39%) have results posted.
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12 of 262 have an industry lead sponsor. The 10 most frequent:
University of Nebraska is the lead sponsor of 496 studies on the registry; 66 are open to participants now.
Of its 83 completed or terminated interventional studies of FDA-regulated products, 53 (64%) have results posted.
University of Nebraska has 3 studies filed under Delirium — fewer than ten, so there is no comparison to draw.
21 of the studies in Delirium with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05431595Phase 3M.D. Anderson Cancer CenterManaging Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy | 2027-02-02 |
| NCT06969287Phase 3Washington University School of MedicineMitigating Delirium With Fluvoxamine Treatment for Non-Cardiac Surgery | 2027-04-01 |
| NCT06192615Phase 3Massachusetts General HospitalMinimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II) | 2027-10-31 |
| NCT03182335University of ChicagoVasopressor SAT Study | 2026-11 |
| NCT05127265University of FloridaPervasive Sensing and AI in Intelligent ICU | 2026-12 |
Add all 21 to your calendar (.ics) → With an account.
Among the 262 studies in Delirium with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The overarching goal of this study is to support the "real world" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Investigators will specifically evaluate two discrete strategies grounded in behavioral economic and implementation science theory (i.e., real-time audit and feedback and registered nurse implementation facilitation) to increase adoption of the ABCDEF bundle in critically ill adults.
Millions of survivors of critical illness worldwide experience profound and frequently persistent physical, mental, and cognitive health impairments that are often preventable through the application of existing knowledge. These impairments are commonly acquired in the intensive care unit (ICU) and are often initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices. Indeed, ICU-acquired pain, anxiety, delirium, and weakness are associated with numerous adverse health outcomes including prolonged MV, mortality, functional decline, new institutionalization, and severe neurocognitive dysfunction. A robust body of research demonstrates that clinical outcomes improve when integrated, interprofessional approaches to MV liberation and symptom management are applied early in the course of critical illness. One such approach is the ABCDEF bundle. When applied in everyday practice, ABCDEF bundle performance is consistently associated with meaningful improvements in important patient and healthcare system outcomes. Unfortunately, ABCDEF bundle performance remains unacceptably low as clinicians struggle with multiple barriers to bundle delivery.
Investigator's previous work demonstrates bundle-related clinical decision making is indeed complex and frequently influenced by prevailing ICU social norms, common knowledge deficits, and substantial workflow challenges. Missing from the literature are evidence-based implementation strategies that are adaptable, responsive to community needs, and account for the cultural and organizational factors necessary to increase bundle adoption particularly in traditionally under-resourced settings like safety net hospitals. Until this key gap in knowledge is filled, the excessively high morbidity, mortality, costs, and disparities associated with critical care delivery will continue and the public health benefit of the ABCDEF bundle will not be fully realized.
Congruent with NIH policy, the goal of this proposal is to support the "real world" assessment of strategies used to foster adoption of several highly efficacious evidence-based practices in healthcare systems that provide care to critically ill adults with known health disparities. Based on strong preliminary data, the study's overall objective is to evaluate two discrete strategies grounded in behavioral economic and implementation science theory to increase adoption of the ABCDEF bundle in critically ill adults. The strategies being evaluated target a variety of ICU team members and known behavioral determinants of ABCDEF bundle performance.
Investigators will conduct a 3-arm, pragmatic, stepped-wedge, cluster-randomized, trial to evaluate both implementation (primary) and clinical (secondary) effectiveness outcomes. After creating 6 matched pairs of 12 ICUs from 3 discrete safety net hospitals (estimated total N=16,500 patients on MV), they will randomly be assigned within each matched pair to receive either real-time audit and feedback or a Registered Nurse (RN) implementation facilitator and each pair to one of six wedges. At the end of the 27-month trial, implementation and clinical outcomes will collected for an additional 3 months to evaluate the effects of removing the implementation strategies.
Aim 1: Primary Implementation Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on proportional ABCDEF bundle performance (primary study outcome).
Aim 1: Secondary Implementation Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on complete ABCDEF bundle performance.
Aim 2: Primary Clinical Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on duration of invasive mechanical ventilation.
Aim 2: Secondary Clinical Objective: Compare the effectiveness of real-time audit and feedback and RN implementation facilitation on other patient-centered outcomes (i.e., new tracheostomy placement; advanced non-invasive respiratory therapy use and duration; ICU, hospital, and 30-day mortality; ICU and hospital length of stay; ICU days with acute brain dysfunction (i.e., ICU delirium and/or coma); ICU physical restraint use; daily and total opioid, benzodiazepine, sedative/hypnotic, antipsychotic, melatonin receptor agonist, and paralytic medication use in ICU stay and at hospital discharge; ICU days with a family visit; discharge disposition; ICU readmission; physical therapy utilization in ICU and at hospital discharge; 30-day hospital readmission; ICU days with significant pain; unplanned extubations; reintubations within 24 hours of extubation; hospital-acquired thromboembolic disease, clinically significant falls acquired during hospitalization, hospital-acquired pressure ulcers).
Aim 3: Identify and describe key stakeholders' experiences with, and perspectives of, real-time audit and feedback and RN implementation.
Aim 3.1: Compare the effects of real-time audit and feedback and RN implementation on work intensity.
Aim 3.2: Compare the acceptability of real-time audit and feedback and RN implementation facilitation.
Aim3.3: Assess the association of work intensity with acceptability and proportional bundle performance.
Aim 3.4: Assess provider perspectives of barriers and facilitators to adoption of real-time audit and feedback and RN implementation.
Building on years of successful collaboration, investigator's experienced interprofessional team is ideally suited to perform the proposed work. Study results are expected to impact the field by developing equitable, efficient, effective, and replicable ways of accelerating the reliable uptake of the highly efficacious evidence-based ICU interventions contained in the ABCDEF bundle. This will dually address known healthcare disparities and ultimately improve the care and outcomes of millions of critically ill adults annually.
The criteria were revised on the registry on Sep 29, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Usual ICU care
ICUs receive electronic dashboard that displays realtime ABCDEF bundle performance data
Behavioral: Realtime audit and feedback
ICUs receive a extra RN who helps facilitate ABCDEF bundle implementation
Behavioral: RN Implementation Facilitator
ICUs randomized to this arm will receive and electronic dashboard that displays realtime ABCDEF bundle performance data
ICUs randomized to this arm will receive a RN who will assist with ABCDEF bundle implementation
Proportional ABCDEF bundle performance
Defined as the percentage of eligible elements a patient receives on a given ICU day \["bundle dose"\].
Time frame: 27 months
Complete ABCDEF bundle performance
Defined as a patient day in which every eligible element of the bundle was performed (i.e., 100% of the bundle versus anything less; yes/no).
Time frame: 27 months
Duration of invasive mechanical ventilation
Days spent in ICU on invasive mechanical ventilation
Time frame: 27 months
Number of participants with new tracheotomy placement
Current Procedural Terminology code for tracheotomy during hospitalization
Time frame: 27 months
advanced noninvasive respiratory therapy use and duration
The recorded timestamps for advanced non-invasive respiratory therapy using CPAP, BiLevel Positive Pressure Ventilation (BiPaP), or high flow cannula with oxygen flow rates \>20 lpm using a face mask or other airway that is NOT an endotracheal tube will be monitored. Specific data elements in the EHR relevant to advanced non-invasive respiratory therapy will be examined. This may include. * Clinical orders for the initiation of BiPaP * Respiratory therapy logs of pressure setting management * Ventilator settings and parameters recorded over time. Once the data is organized, the duration of advanced non-invasive respiratory therapy for each patient will be calculated using the following formula: Duration (in hours) = CPAP/BiPaP/High Flow Oxygen Initiation Time - CPAP/BiPaP/High Flow OxygenTermination Time
Time frame: 27 months
Number of participants with an ICU mortality
A death event that is recorded in the electronic health record (EHR) that occurred after index ICU admission and prior to the index ICU discharge date and time
Time frame: 27 months
Number of participants with a hospital mortality
A death event that is recorded in the EHR that occurred after index ICU admission and prior to discharge from the hospital on the index hospital stay.
Time frame: 27 months
Number of participants who die within 30 days of hospital discharge
A death event that is recorded in the EHR that occurs within 30 days of the date of hospital discharge from the index hospital stay.
Time frame: 27 months
ICU length of stay (LOS)
Date and time of ICU discharge minus the date and time of ICU admission. Each ICU stay will be recorded as unique ICU stays as a unique ICU encounter.
Time frame: 27 months
hospital LOS
Date and time of hospital discharge minus the date and time of first encounter during the hospital encounter
Time frame: 27 months
ICU days with acute brain dysfunction
Will record ICU days with delirium. A delirious day would include a 24-hour period with at least one Confusion Assessment Method ICU (CAM ICU) score that is measured as positive. The total would include the total number of days for which CAM ICU is measured to be positive. ICU coma days: Will record any day for which patients exhibit level of arousal scores consistent with coma (Richmond agitation/sedation score -4 or -5, Sedation agitation score of 1 or 2) and add the total number of coma days throughout any given ICU stay, and across all ICU stays within a hospitalization.
Time frame: 27 months
ICU days with physical restraint use
Physical restraint status codes will be identified using the International Classification of Disease code Z78.1 "physical restraint status".
Time frame: 27 months
Opioid, benzodiazepine, sedative/hypnotic, and antipsychotic medication use in ICU and at hospital discharge
Opioid, benzodiazepine, sedative/hypnotic, antipsychotic medication, and melatonin receptor agonist medication use in ICU and at hospital discharge as recorded in EHR
Time frame: 27 months
Discharge destination
Will review hospital discharge destination coded as home, home with home health, short term skilled nursing facility, long term nursing facility, acute rehabilitation hospital, long-term acute care hospital, hospice, acute care hospital, death.
Time frame: 27 months
Number of participants with an ICU readmission
Will be coded yes if a patient has at least one readmission to any ICU following discharge from the index ICU stay.
Time frame: 27 months
Number of participants with 30 day hospital readmission
Coded yes if a patient has at least one hospital readmission following discharge from the index hospital stay. Importantly, will only be able to track same-hospital readmissions.
Time frame: 27 months
Number of participants with physical therapy use in ICU and post discharge
Will collect data regarding daily interactions with physical therapy.
Time frame: 27 months
Days with significant pain
Will define an ICU Day as having an episode of significant pain if any of the below are documented; Numeric rating score: A score of \> 7 will be considered significant pain; critical care pain observation tool: A score \> 2 will be considered significant pain; Behavioral pain scale: A score \> 5 will be considered significant pain; Defense and Veterans Pain Rating Scale: A score \> 4 will be considered significant pain; Pain in Alzheimer Disease score: A score \> 4 will be considered significant pain
Time frame: 27 months
Number of participants with a reintubation within 24 hours of extubation
Will assess for evidence of an order for intubation that occurs \< 24 hours following evidence of extubation, or a prior order for extubation.
Time frame: 27 months
Number of participants with an unplanned extubation
Will assess for evidence of extubations that do not follow provider orders for an extubation and/or are charted as unordered.
Time frame: 27 months
Number of participants with hospital acquired thromboembolic disease
Will query for International Classification of Disease codes associated with thromboembolic disease. Diagnosis codes must be a secondary diagnosis code / hospital acquired
Time frame: 27 months
Number of participants with a hospital acquired fall with injury
Will record fall and trauma coding consistent with the Center for Medicare Services Health Acquired Conditions specification for fracture, dislocation, and intracranial injury.
Time frame: 27 months
Number of participants with a hospital acquired pressure ulcer
The codes for hospital acquired pressure ulcer will be consistent with the Center for Medicare Services Hospital Acquired Conditions coding.
Time frame: 27 months
ICU days with family visit
Electronic health record documentation of family visit that occurred during ICU stay
Time frame: 27 months
work intensity
6 item National Aeronautics and Space Administration Task Load Index; Higher scores indicate higher work intensity
Time frame: 27 months
acceptability
4 item Acceptability of Intervention Measure; higher scores indicate greater acceptability
Time frame: 27 months
Plan to share: Yes — To support study replication and extension, all scientific data including operations and clinical data necessary for replication of this project will be made available in de-identified form before publication, or by the end of the funded period (whichever comes first) in an appropriate online repository. Data used for analysis will be stored in comma-separated values file format to aid in the reuse of collected and analyzed data. Both clinical locations and patient information will be de-identified. All HIPAA identifiers will be removed and low counts will be masked as well. Original data will be maintained at the principal investigator's institution . There will be no restriction to sharing the data.
Supporting information: Study protocol, Statistical analysis plan
Time frame: To support study replication and extension, all scientific data including operations and clinical data necessary for replication of this project will be made available in de-identified form before publication, or by the end of the funded period (whichever comes first) in an appropriate online repository. Data used for analysis will be stored in comma separated values format to aid in the reuse of collected and analyzed data. Both clinical locations and patient information will be de-identified. All HIPAA identifiers will be removed and low counts will be masked. Original data will be maintained at the principal investigator's institution . There will be no restriction to sharing the data.
Access criteria: To support study replication and extension, all scientific data, including operational and clinical data necessary for replicating this project, will be made available in de-identified form before publication, or by the end of the funded period (whichever comes first), in an appropriate online repository. Data used for analysis will be stored in comma-separated values format to aid in the reuse of collected and analyzed data. Both clinical locations and patient information will be de-identified. All HIPAA identifiers will be removed and low counts will be masked. Original data will be maintained at the principal investigator's institution. There will be no restriction to sharing the data.
Started Jul 2024 (actual). Primary completion is estimated for Apr 2028, 45 months after the start.
Of 219 non-industry interventional studies with no phase under Delirium, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 45 months is above that.
Counting every sponsor, half of 222 studies reached it within 26 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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