Implementation ScienceBEST-ICUNCT06184945
Behavioral Economic & Staffing Strategies in the ICU
A study testing Realtime audit and feedback and RN Implementation Facilitator in people with Implementation Science and Delirium, run by University of Nebraska at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Implementation Science, Delirium, Critical Illness
- What is being tested?
- Realtime audit and feedback and RN Implementation Facilitator
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,500 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2024to Apr 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > or = to 19 years at time of ICU admission
- Received invasive mechanical ventilation while in a cluster ICU
- Admitted to participating cluster ICU
- Cluster ICU length of stay of at least 24 hours
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Ohio State University
Columbus, Ohio, 43201
Matthew Exline, MD, (614) 293-4925, matthew.exline@osumc.edu
Tony Gerlach, PHD, (614) 688-0234, anthony.gerlach@osumc.edu
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
James Blum, MD, (319) 678-7116, james-blum@uiowa.edu
Anna Krupp, PhD, RN, (319) 467-1902, anna-krupp@uiowa.edu
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Michele C Balas, PhD, RN, (402) 559-9758, mibalas@unmc.edu
Breanna D Hetland, PhD
About this study
Official title: 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.
Read the 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=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.
- Conditions
- Implementation Science, Delirium, Critical Illness, Mechanical Ventilation Complication, ICU Acquired Weakness, Pain
- Being tested
- Realtime audit and feedback, RN Implementation Facilitator
- Keywords
- ABCDEF bundle, delirium, intensive care, critical care, mechanical ventilation
- Medical subject headings
- Delirium, Critical Illness, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Realtime audit and feedbackBehavioural
ICUs randomized to this arm will receive and electronic dashboard that displays realtime ABCDEF bundle performance data
RN Implementation FacilitatorBehavioural
ICUs randomized to this arm will receive a RN who will assist with ABCDEF bundle implementation
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Usual ICU care |
| Audit and Feedback | Experimental | ICUs receive electronic dashboard that displays realtime ABCDEF bundle performance data Receives: Behavioral: Realtime audit and feedback |
| RN Implementation Facilitator | Experimental | ICUs receive a extra RN who helps facilitate ABCDEF bundle implementation Receives: Behavioral: RN Implementation Facilitator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportional ABCDEF bundle performance
Defined as the percentage of eligible elements a patient receives on a given ICU day ["bundle dose"].
Measured: 27 months
Secondary outcomes (2)
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).
Measured: 27 months
Duration of invasive mechanical ventilation
Days spent in ICU on invasive mechanical ventilation
Measured: 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2023
- Study start1 Jul 2024
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Implementation ScienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pragmatic, stepped-wedge, cluster-randomized, hybrid type III effectiveness-implementation trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, University of Iowa, University of Wisconsin, Madison, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Michele C Balas, PhD, RN, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184945
- Sponsor's protocol ID
- 0794-23-FB
- Other IDs
- 1UG3HL165740-01A1, 4UH3HL165740-02
- Acronym
- BEST-ICU
- Status last verified
- Oct 2026
- First submitted
- 5 Dec 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 41388315