Behavioral Economic & Staffing Strategies for Critical Illness

(BEST-ICU Trial)

Recruiting at 2 trial locations

Overseen By Eduard Vasilevskis, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Nebraska

Disqualifiers: Chronic ventilation, Prisoners

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

8100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests methods to enhance care for critically ill adults in hospitals, particularly those experiencing health disparities. It employs two strategies: an extra nurse to guide care (RN Implementation Facilitator) and a digital dashboard providing real-time feedback on care performance (Realtime audit and feedback). The goal is to determine if these strategies more effectively apply a specific care bundle known as ABCDEF, which aims to improve patient outcomes. This trial suits those who have been on a ventilator in the ICU for at least 24 hours. As an unphased trial, it offers a unique opportunity to contribute to innovative care improvements that can benefit future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these strategies are safe for critically ill adults?

Studies have shown that real-time audit and feedback in intensive care units (ICUs) can be safe and helpful. Research indicates that real-time audits, which are checks to improve healthcare performance, are practical and can enhance patient care. No major safety concerns have been reported with this approach.

Research into the role of a registered nurse (RN) Implementation Facilitator, who guides care teams, also suggests that this strategy is safe. This method focuses on improving teamwork and care decisions in critical settings. Nurses in similar roles have reported positive experiences, noting better communication and patient care without any serious safety issues.

Overall, both strategies have been used safely in healthcare settings, with no evidence of significant safety problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative strategies to improve ICU care for critically ill patients. Unlike standard ICU care, which typically follows established protocols, this trial tests two new approaches: the RN Implementation Facilitator and Realtime Audit and Feedback. The RN Implementation Facilitator introduces an extra nurse dedicated to seamlessly implementing the ABCDEF bundle, which aims to optimize patient outcomes. Meanwhile, the Realtime Audit and Feedback uses an electronic dashboard to provide immediate performance data, helping staff improve care efficiency and effectiveness. These methods could lead to more personalized and responsive ICU care, potentially enhancing recovery for critically ill patients.

What evidence suggests that this trial's strategies could be effective for critically ill adults?

In this trial, participants will join different treatment arms to evaluate strategies for improving ICU care. One arm includes a Registered Nurse (RN) Implementation Facilitator in the ICU. Research has shown that these facilitators can enhance efficiency and patient care by helping the medical team collaborate and make crucial decisions, which is vital in critical care. They also consistently support patients and their families, enhancing the overall care experience.

Another arm will test the real-time audit and feedback strategy. Research has found that this approach can effectively enhance ICU care quality by using data to provide performance feedback, which can improve areas like pain management. Although some studies suggest it works better in certain cases, it is commonly used to improve care quality in critical settings. ^{1 2 6 7 8}

Who Is on the Research Team?

Michele C Balas, PhD, RN

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for adults over 19 who are admitted to the ICU, have been on a ventilator there, and stayed at least 24 hours. It's not for patients already on long-term ventilation from home or care facilities, nor prisoners.

Inclusion Criteria

I was on a breathing machine in the ICU.

I have stayed in the ICU for at least 24 hours.

I was older than 19 when I was admitted to the ICU.

Exclusion Criteria

Prisoners

I am in the hospital and was already on a ventilator before admission.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation Phase

ICUs receive either real-time audit and feedback or a Registered Nurse implementation facilitator to increase adoption of the ABCDEF bundle

27 months

Follow-up

Implementation and clinical outcomes are collected for an additional 3 months to evaluate the effects of removing the implementation strategies

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Realtime audit and feedback
• RN Implementation Facilitator

Trial Overview The study tests two strategies in ICUs: real-time audit and feedback plus nurse-led implementation facilitation. The goal is to see if these improve the use of ABCDEF bundle practices among critically ill adults.

How Is the Trial Designed?

Group I: RN Implementation Facilitator Experimental Treatment 1 Intervention

ICUs receive a extra RN who helps facilitate ABCDEF bundle implementation

Group II: Audit and Feedback Experimental Treatment 1 Intervention

ICUs receive electronic dashboard that displays realtime ABCDEF bundle performance data

Group III: Usual care Active Control 1 Intervention

Usual ICU care

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

University of Wisconsin, Madison

Collaborator

Trials

1,249

Recruited

3,255,000+

University of Iowa

Collaborator

Trials

486

Recruited

934,000+

Published Research Related to This Trial

A qualitative study involving 72 clinicians from various ICUs revealed that audit and feedback processes are often seen as fragmented and ineffective, leading to feelings of disconnection among staff.

To enhance the effectiveness of audit and feedback in ICUs, clinicians suggested improvements such as timely and actionable feedback, better communication about the audit process, and more inclusive discussions that engage all team members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative study of the variable effects of audit and feedback in the ICU. Sinuff, T., Muscedere, J., Rozmovits, L., et al.[2022]

Effective Audit & Feedback (A&F) requires timely and tailored feedback that addresses specific priorities of recipients, recommends actionable improvements, and allows recipients to manage the recommendations themselves.

To enhance the impact of feedback, it should be presented in multiple formats, linked closely to key messages, and designed to minimize cognitive overload, while also fostering motivation and participation in the feedback process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fifteen ways to optimize feedback.] Di Blasio, N., Bramanti, P., Licata, S., et al.[2023]

Audit and Feedback (A&F) can significantly improve patient care by providing actionable insights, but its effectiveness is often hindered by challenges in data validity, feedback interpretation, and the ability to implement changes.

Successful implementation of A&F requires a supportive culture, adequate leadership, and sometimes coaching to help healthcare teams translate feedback into practical actions for improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A&F: obstacles to implementing interventions in the health system.] Di Blasio, N., Acampora, A., Bonomi, A., et al.[2023]

In a study involving 40 internal medicine teams, intensive audit and feedback methods, including daily data dashboards and weekly performance reviews, significantly improved the completion of discharge metrics (79.3% vs. 63.2% in the control group, P<0.0001).

The effectiveness of the intensive feedback diminished after the intervention ended, indicating that continuous and timely feedback is crucial for maintaining improved performance in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Next-generation audit and feedback for inpatient quality improvement using electronic health record data: a cluster randomised controlled trial. Patel, S., Rajkomar, A., Harrison, JD., et al.[2019]

This study will explore how electronic audit and feedback can enhance ICU professionals' intentions to improve pain management practices, aiming to bridge the gap between intention and actual behavior.

By comparing feedback with and without an action implementation toolbox in Dutch ICUs, the research seeks to determine which method more effectively translates improvement intentions into better patient care outcomes, specifically in managing pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic audit and feedback intervention with action implementation toolbox to improve pain management in intensive care: protocol for a laboratory experiment and cluster randomised trial. Gude, WT., Roos-Blom, MJ., van der Veer, SN., et al.[2022]

A systematic review of 140 studies found that audit and feedback can lead to a small but significant increase (4.3%) in healthcare professionals' compliance with desired practices, particularly when baseline performance is low.

The effectiveness of audit and feedback is enhanced when it is delivered multiple times, by a supervisor or colleague, and includes both verbal and written formats along with clear targets and action plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Audit and feedback: effects on professional practice and healthcare outcomes. Ivers, N., Jamtvedt, G., Flottorp, S., et al.[2022]

The effectiveness of electronic audit and feedback (e-A&F) interventions in improving quality of care is highly variable, as shown by a meta-analysis of seven studies involving 81,700 patients and 329 healthcare professionals, with many studies exhibiting medium to high risk of bias.

Most e-A&F interventions targeted theoretical domains like 'knowledge', 'social influences', and 'goals', but did not comprehensively address all relevant domains, indicating a need for future research to better understand which theoretical factors are crucial for enhancing the effectiveness of e-A&F interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of electronic audit and feedback: intervention effectiveness and use of behaviour change theory. Tuti, T., Nzinga, J., Njoroge, M., et al.[2023]

A performance improvement project at a burn center showed that providing tailored feedback to nurses significantly increased the accuracy of delirium documentation from 49.15% to 91.47%.

Before implementing corrective feedback, none of the audits met the 90% documentation accuracy goal, but after the intervention, 60% of audits achieved this target, demonstrating the effectiveness of feedback in improving nursing practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Tailored Feedback Improves Accuracy of Delirium Documentation in the Burn ICU: Results of a Performance Improvement Initiative. Gloger, AN., Nakonezny, PA., Phelan, HA.[2021]

The electronic audit and feedback (A&F) intervention with an action implementation toolbox significantly increased the number of planned actions aimed at improving pain management in ICUs, compared to A&F alone, indicating its effectiveness in facilitating action planning.

ICUs using the toolbox not only planned more diverse actions but also reported fewer difficulties in identifying actionable steps, suggesting that the toolbox broadens health professionals' perspectives on potential changes in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating action planning within audit and feedback interventions: a mixed-methods process evaluation of an action implementation toolbox in intensive care. Gude, WT., Roos-Blom, MJ., van der Veer, SN., et al.[2021]

A study involving 25,552 ICU admissions across 30 Dutch hospitals found that a multifaceted performance feedback strategy did not improve patient outcomes compared to standard benchmark reports.

Despite efforts to enhance quality improvement through local teams and regular feedback, there was no significant reduction in ICU length of stay or other secondary health measures, indicating that simply increasing feedback and responsibility may not be enough to drive better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a multifaceted performance feedback strategy on length of stay compared with benchmark reports alone: a cluster randomized trial in intensive care*. van der Veer, SN., de Vos, ML., van der Voort, PH., et al.[2013]

A study involving 822 women showed that daily audit and feedback during weekdays for using a cesarean risk calculator had a sustained impact on its use even during weekends when no feedback was provided, indicating the effectiveness of this implementation strategy.

The use of the cesarean risk calculator was similar on weekdays (82.0%) and weekends (83.0%), suggesting that weekday feedback can lead to lasting improvements in practice without the need for continuous oversight on weekends.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily weekday audit and feedback to clinicians for an inpatient intervention in obstetrics: is there sustained impact over the weekend? A secondary analysis of a prospective cohort study. Hamm, RF., Levine, LD., Lane-Fall, M., et al.[2021]

The SMART study aims to improve medication error reporting among nurses by implementing a feedback mechanism that provides quarterly audit data on medication errors over a 12-month period in matched wards of an acute care hospital.

This quasi-experimental design will evaluate the effectiveness of the feedback intervention and its impact on nurses' reporting behavior, with the potential for broader applications in reducing preventable errors in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of an audit with feedback knowledge translation intervention to promote medication error reporting in health care: a protocol. Hutchinson, AM., Sales, AE., Brotto, V., et al.[2018]

The study analyzed feedback from patient safety incident reporting systems across 351 NHS trusts in England and Wales, highlighting the importance of effective feedback mechanisms in improving patient safety.

Key recommendations were developed from expert insights and case studies, which can help healthcare organizations enhance their incident reporting systems and learning processes, making them applicable not only in the UK but also in global health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving patient safety incident reporting systems by focusing upon feedback - lessons from English and Welsh trusts. Wallace, LM., Spurgeon, P., Benn, J., et al.[2022]

Citations

1. nursing.uiowa.edu nursing.uiowa.edu/sites/nursing.uiowa.edu/files/2025-05/stephensonclaire_243740_30479843_Stephenson%20Honors%20Poster_VF_0.pdf

Evaluating the Role of an RN Facilitator in Enhancing ICU ... ➢ These findings support the integration of. RN facilitators in ICU settings as a strategy to improve workflow efficiency and patient outcomes in critical care.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11650680/

A conceptual analysis of facilitation to improve clinical ... Effective facilitation is crucial to improve critical care outcomes in life-threatening conditions through improved teamwork, caring, decision-making, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392424012326

Perspectives on Implementing a Communication Facilitator ... Clinicians reported that facilitators provided continuity to patients and families, support in a trusting and proactive manner over transitions of care, and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04133753

Evaluating Effectiveness of a Communication Facilitator ... This study is a randomized clinical trial of an intervention to improve outcomes for patients and their family by using ICU nurse facilitators to support, ...

5. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2836585

Nurse-Led Family Support Intervention for ... The family support intervention aimed to increase capacity for and quality of family-focused ICU care, reduce families' burden, and improve ...

6. dcricollab.dcri.duke.edu dcricollab.dcri.duke.edu/sites/NIHKR/KR/BEST-ICU%20Study%20Snapshot.pdf

BEST-ICU Study Snapshot.pdf The trial will compare the effectiveness of the 2 strategies on ABCDEF bundle adoption (the primary outcome) and several clinical outcomes, including duration ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocn.70086

Barriers and Facilitators in Implementing Clinical Practice ... This systematic review explores barriers and facilitators influencing clinical practice guideline (CPG) implementation among nurses in emergency ...

8. rethinkingclinicaltrials.org rethinkingclinicaltrials.org/demonstration-projects/behavioral-economic-and-staffing-strategies-to-increase-adoption-of-the-abcdef-bundle-in-the-icu-best-icu/

UH3 Project: Behavioral Economic and Staffing Strategies ... Survivors of critical illness frequently experience profound health impairments brought about or exacerbated by outdated mechanical ventilation and symptom ...