Behavioral Economic & Staffing Strategies in the ICU

NCT ID: NCT06184945

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 8100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2028-04-30

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.

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care unit (ICU) and are often initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices.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=8,100 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: Compare the effectiveness of real-time audit and feedback and RN implementation facilitator on ABCDEF bundle adoption (primary study outcome).

Aim 2: Compare the effectiveness of real-time audit and feedback and RN implementation facilitator on clinical outcomes.

Aim 3: Identify and describe key stakeholders' experiences with, and perspectives 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual care

Usual ICU care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Audit and Feedback

ICUs receive electronic dashboard that displays realtime ABCDEF bundle performance data

Group Type: EXPERIMENTAL

Realtime audit and feedback

Intervention Type: BEHAVIORAL

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

RN Implementation Facilitator

ICUs receive a extra RN who helps facilitate ABCDEF bundle implementation

Group Type: EXPERIMENTAL

RN Implementation Facilitator

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

RN Implementation Facilitator

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ohio State University

OTHER

Sponsor Role: collaborator

University of Iowa

OTHER

Sponsor Role: collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele C Balas, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status: RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, United States

Site Status: RECRUITING

Ohio State University

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michele C Balas, PhD, RN

Role: CONTACT

mibalas@unmc.edu

(614) 949-5555

Eduard Vasilevskis, MD

Role: CONTACT

vasilevskis@wisc.edu

(608) 261-1571

Facility Contacts

James Blum, MD

Role: primary

james-blum@uiowa.edu

(319) 678-7116

Anna Krupp, PhD, RN

Role: backup

anna-krupp@uiowa.edu

(319) 467-1902

Michele C Balas, PhD, RN

Role: primary

mibalas@unmc.edu

(402) 559-9758

Matthew Exline, MD

Role: primary

matthew.exline@osumc.edu

(614) 293-4925

Tony Gerlach, PHD

Role: backup

anthony.gerlach@osumc.edu

(614) 688-0234

Other Identifiers

1UG3HL165740-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

4UH3HL165740-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0794-23-FB

Identifier Type: -

Identifier Source: org_study_id