Recruiting

ABCDEF Bundle

Sponsor:

University of Nebraska

Code:

NCT06184945

Conditions

Implementation Science

Delirium

Critical Illness

Mechanical Ventilation Complication

ICU Acquired Weakness

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Realtime audit and feedback

RN Implementation Facilitator

Study Details

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

Study ID

NCT06184945

Start date

Jul 1, 2024

Status verified date

Sep, 2025

Completion date

Apr, 2028

Anticipated

Primary completion date

Apr, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

8100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Usual care

Usual ICU care

experimental: Audit and Feedback

ICUs receive electronic dashboard that displays realtime ABCDEF bundle performance data

experimental: RN Implementation Facilitator

ICUs receive a extra RN who helps facilitate ABCDEF bundle implementation

Interventions

Realtime audit and feedback

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

RN Implementation Facilitator

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

Primary outcome measure

  • Proportional ABCDEF bundle performance [ Time Frame: 27 months ]

Central Contacts and Locations

Central contacts

Michele C Balas, PhD, RN

(614) 949-5555mibalas@unmc.edu

Eduard Vasilevskis, MD

(608) 261-1571vasilevskis@wisc.edu

Locations

University of Iowa Hospitals and Clinics

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

James Blum, MD

(319) 678-7116james-blum@uiowa.edu

Anna Krupp, PhD, RN

(319) 467-1902anna-krupp@uiowa.edu

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198

Contacts

Michele C Balas, PhD, RN

(402) 559-9758mibalas@unmc.edu

Principal Investigator:

Breanna D Hetland, PhD

Ohio State University

Recruiting

Columbus, Ohio, United States, 43201

Contacts

Matthew Exline, MD

(614) 293-4925matthew.exline@osumc.edu

Tony Gerlach, PHD

(614) 688-0234anthony.gerlach@osumc.edu

More Information

Sponsor

University of Nebraska

Last update posted

Feb 19, 2026

Last verified

Sep, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Nebraska on 2026-02-19.