Behavioral Economic & Staffing Strategies in the ICU (BEST-ICU)

Behavioral Economic and Staffing Strategies To Increase Adoption of an Evidence Based Bundle in the Intensive Care Unit (BEST ICU): A Stepped Wedge Cluster Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pain; Delirium; Critical Illness; Mechanical Ventilation Complication; ICU Acquired Weakness; Implementation Science
• Intervention / Treatment: Behavioral: Realtime audit and feedback; Behavioral: RN Implementation Facilitator

Detailed Description

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care unit (ICU) and are often initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices.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=8,100 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 8100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele C Balas, PhD, RN; Phone Number: (614) 949-5555; Email: mibalas@unmc.edu
• Study Contact Backup: Name: Eduard Vasilevskis, MD; Phone Number: (608) 261-1571; Email: vasilevskis@wisc.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Hospitals and Clinics
      • Contact: Anna Krupp, PhD, RN; Phone Number: (319) 467-1902; Email: anna-krupp@uiowa.edu
      • Contact: James Blum, MD; Phone Number: (319) 678-7116; Email: james-blum@uiowa.edu
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Principal Investigator: Breanna D Hetland, PhD
      • Sub-Investigator: Chris S Wichman, PhD
      • Sub-Investigator: James R Campbell, PhD
      • Sub-Investigator: Ronnie Horner, PHD
      • Sub-Investigator: Jungyoon Kim, PhD
      • Contact: Michele C Balas, PhD, RN; Phone Number: (402) 559-9758; Email: mibalas@unmc.edu
  • Ohio
    • Columbus, Ohio, United States, 43201
      • Recruiting
      • Ohio State University
      • Contact: Tony Gerlach, PHD; Phone Number: (614) 688-0234; Email: anthony.gerlach@osumc.edu
      • Contact: Matthew Exline, MD; Phone Number: (614) 293-4925; Email: matthew.exline@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >19 years at time of ICU admission
• Received invasive mechanical ventilation while in the ICU
• Admitted to participating cluster ICU
• ICU length of stay of at least 24 hours

Exclusion Criteria:

• Patient who is admitted to the hospital who is already receiving chronic long-term mechanical ventilation from the home, assisted living, or long-term care setting
• Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care; Usual ICU care
Experimental: Audit and Feedback; ICUs receive electronic dashboard that displays realtime ABCDEF bundle performance data	Behavioral: Realtime audit and feedback; ICUs randomized to this arm will receive and electronic dashboard that displays realtime ABCDEF bundle performance data
Experimental: RN Implementation Facilitator; ICUs receive a extra RN who helps facilitate ABCDEF bundle implementation	Behavioral: RN Implementation Facilitator; ICUs randomized to this arm will receive a RN who will assist with ABCDEF bundle implementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportional ABCDEF bundle performance	Defined as the percentage of eligible elements a patient receives on a given ICU day ["bundle dose"].	27 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	27 months
Duration of invasive mechanical ventilation	Days spent in ICU on invasive mechanical ventilation	27 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
hospital LOS	Date and time of hospital discharge minus the date and time of first encounter during the hospital encounter	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.	27 months
Number of participants with new tracheotomy placement	Current Procedural Terminology code for tracheotomy during hospitalization	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	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.	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.	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.	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.	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".	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.	27 months
Number of participants with physical therapy use in ICU and post discharge	Will collect data regarding daily interactions with physical therapy.	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	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.	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.	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	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.	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.	27 months
ICU days with family visit	Electronic health record documentation of family visit that occurred during ICU stay	27 months
work intensity	6 item National Aeronautics and Space Administration Task Load Index; Higher scores indicate higher work intensity	27 months
acceptability	4 item Acceptability of Intervention Measure; higher scores indicate greater acceptability	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	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	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.	27 months

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); University of Iowa; University of Wisconsin, Madison; Ohio State University
• Investigators: Principal Investigator: Michele C Balas, PhD, RN, University of Nebraska

Publications and helpful links

General Publications

• Vasilevskis EE, Kim J, Wichman C, Horner R, Campbell JR, Geary CR, Birge J, Hetland B, Blanchard A, Circo K, Wagner-Connolly A, Miller J, Exline MC, Gerlach AT, Krupp A, Blum J, Balas MC; BEST-ICU Team. Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the Intensive Care Unit (BEST ICU): study protocol for a multi-site stepped-wedge cluster randomized controlled trial in the USA. Trials. 2025 Dec 12;27(1):42. doi: 10.1186/s13063-025-09331-6.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: December 5, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: ABCDEF bundle, delirium, intensive care, critical care, mechanical ventilation
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Pathologic Processes; Disease Attributes; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Delirium; Critical Illness
• Other Study ID Numbers: 0794-23-FB; 1UG3HL165740-01A1 (U.S. NIH Grant/Contract); 4UH3HL165740-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No