Behavioral Economic & Staffing Strategies in the ICU

NCT06184945 | Recruiting DMC

• 3 other identifiers: 0794-23-FB1UG3HL165740-01A14UH3HL165740-02
• Study Type: interventional
• Target: 8,100
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Implementation Science; Delirium; Critical Illness; Mechanical Ventilation Complication; ICU Acquired Weakness; Pain

Keywords

ABCDEF bundle, delirium, intensive care, critical care, mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• Proportional ABCDEF bundle performance

  Defined as the percentage of eligible elements a patient receives on a given ICU day \["bundle dose"\].

  27 months

Secondary Outcomes (2)

• Complete ABCDEF bundle performance

  27 months

• Duration of invasive mechanical ventilation

  27 months

Other Outcomes (23)

• Number of participants with new tracheotomy placement

  27 months

• advanced noninvasive respiratory therapy use and duration

  27 months

• Number of participants with an ICU mortality

  27 months

Study Arms (3)

Usual care

NO INTERVENTION

Usual ICU care

Audit and Feedback

EXPERIMENTAL

ICUs receive electronic dashboard that displays realtime ABCDEF bundle performance data

Behavioral: Realtime audit and feedback

RN Implementation Facilitator

EXPERIMENTAL

ICUs receive a extra RN who helps facilitate ABCDEF bundle implementation

Behavioral: RN Implementation Facilitator

Interventions

Realtime audit and feedback BEHAVIORAL

ICUs randomized to this arm will receive and electronic dashboard that displays realtime ABCDEF bundle performance data

Audit and Feedback

RN Implementation Facilitator BEHAVIORAL

ICUs randomized to this arm will receive a RN who will assist with ABCDEF bundle implementation

RN Implementation Facilitator

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Ohio State University: collaborator
• University of Iowa: collaborator
• University of Wisconsin, Madison: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (3)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43201, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 41388315 DERIVED

MeSH Terms

Conditions

Delirium; Critical Illness; Pain

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Michele C Balas, PhD, RN

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele C Balas, PhD, RN

CONTACT

(614) 949-5555; mibalas@unmc.edu

Eduard Vasilevskis, MD

CONTACT

(608) 261-1571; vasilevskis@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: pragmatic, stepped-wedge, cluster-randomized, hybrid type III effectiveness-implementation trial

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 29, 2023
• Study Start: July 1, 2024
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: February 19, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.

Locations

US (3)