Study of Behavioral and Staffing Methods to Improve ICU Care for Adults on Mechanical Ventilation
A Stepped Wedge Cluster Randomized Trial Evaluating ABCDEF Bundle Adoption
Led by University of Nebraska · Updated on 2026-02-19
8100
Participants Needed
3
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Millions of adults who survive critical illness suffer lasting physical, mental, and cognitive problems often linked to care received in intensive care units ICUs. These health issues are worsened by racial and socioeconomic disparities and outdated care practices. Researchers are studying ways to improve the use of the ABCDEF bundle, an evidence-based approach to managing mechanical ventilation and symptoms early during critical illness, which is known to improve patient outcomes but is underused in many ICUs.
This study compares two behavioral strategies aimed at increasing adoption of the ABCDEF bundle in ICUs real-time audit and feedback via an electronic dashboard showing performance data, and support from a registered nurse RN who helps implement the bundle. Twelve ICUs in three hospitals will be grouped and randomly assigned to receive usual care, the audit and feedback, or RN facilitation in a stepped-wedge design over 27 months, followed by a 3-month period without the strategies to assess lasting effects.
Participants include critically ill adults over 19 years old who have received invasive mechanical ventilation and stayed in the ICU for at least 24 hours. Researchers will evaluate bundle adoption rates, duration of mechanical ventilation, and various patient-centered outcomes like mortality, delirium, medication use, and hospital readmission. The study also examines staff experiences, workload, and barriers to adopting these strategies, with data collected throughout the trial and during the follow-up period.
CONDITIONS
Brief Title
Behavioral Economic & Staffing Strategies in the ICU
Research Team
M
Michele C Balas, PhD, RN
E
Eduard Vasilevskis, MD
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
Audit and Feedback (trial arm)
RN Implementation Facilitator (trial arm)
Standard ABCDEF Bundle (current practice)
What it is
An ICU-wide behavioral intervention using a real‑time electronic dashboard to display current ABCDEF bundle performance data to staff.
An ICU‑based strategy where a registered nurse facilitates implementation of the ABCDEF bundle.
Structured implementation of the ABCDEF bundle as standard ICU practice.
Role in trial
One of two randomised implementation strategies being evaluated against usual care.
One of two randomised implementation strategies being evaluated against usual care.
Represents typical ICU practice where the ABCDEF bundle is commonly used.
Primary use
To increase adoption of the ABCDEF bundle through feedback on performance data.
To support bundle adoption by embedding a nurse facilitator into ICU workflow.
To deliver comprehensive ICU patient care following evidence‑based ABCDEF components.
How it is given or performed
Staff view a real‑time electronic dashboard showing performance metrics for each ABCDEF component.
A registered nurse actively assists ICU staff with implementation tasks for the ABCDEF bundle.
Multidisciplinary ICU teams apply structured ABCDEF processes including pain, sedation, delirium, mobility, and family engagement protocols.
Evidence status
Effectiveness being evaluated; actual trial results not yet available.
Effectiveness under investigation; results pending.
Implementation is linked with reductions in ICU mortality, delirium incidence and duration, mechanical ventilation duration, and improved mobilization.
Important risks
No known physical risks; focuses on facilitating practice change.
No direct physical risks; involves nurse participation in implementation.
No added physical risks; designed to improve patient outcomes via coordinated evidence‑based care.
Important limitations
Effectiveness may depend on local ICU culture, staff engagement, and technology infrastructure.
Success may vary based on staffing levels, training, and unit workflow integration.
High-fidelity adoption is challenging; full bundle implementation is often inconsistent.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
Age greater than 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 will not qualify if you...
Patients already receiving chronic long-term mechanical ventilation from home, assisted living, or long-term care settings
Prisoners
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Outpatient Treatment
Duration - 27 months
Participants receive behavioral economic and staffing strategies in the ICU to increase adoption of an evidence-based care bundle.
Follow-up
Duration - 3 months
After the treatment period, participants are monitored for an additional 3 months to evaluate the effects of removing the implementation strategies.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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Published Research Related To This Trial
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.
Eduard E Vasilevskis, Jungyoon Kim, Christopher Wichman...