Clinical trial NCT06184945: Behavioral Economic & Staffing Strategies in the ICU
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Implementation Science
Delirium
Critical Illness
Mechanical Ventilation Complication
ICU Acquired Weakness
Pain
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: University of Iowa
name: University of Wisconsin, Madison
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-12-29
Enrollment: 8100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pragmatic, stepped-wedge, cluster-randomized, hybrid type III effectiveness-implementation trial
Primary purpose: TREATMENT

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care unit (ICU) and are often initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices.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.

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

Primary outcomes:
measure: Proportional ABCDEF bundle performance
timeFrame: 27 months
Secondary outcomes:
measure: Complete ABCDEF bundle performance
timeFrame: 27 months
measure: Duration of mechanical ventilation
timeFrame: 27 months
Other outcomes:
measure: Number of participants with new tracheotomy placement
timeFrame: 27 months
measure: noninvasive mechanical ventilation duration
timeFrame: 27 months
measure: Number of participants with an ICU mortality
timeFrame: 27 months
measure: Number of participants with a hospital mortality
timeFrame: 27 months
measure: Number of participants who die within 30 days of hospital discharge
timeFrame: 27 months
measure: ICU length of stay (LOS)
timeFrame: 27 months
measure: hospital LOS
timeFrame: 27 months
measure: ICU days with acute brain dysfunction
timeFrame: 27 months
measure: ICU days with physical restraint use
timeFrame: 27 months
measure: Opioid, benzodiazepine, sedative/hypnotic, and antipsychotic medication use in ICU and at hospital discharge
timeFrame: 27 months
measure: Discharge destination
timeFrame: 27 months
measure: Number of participants with an ICU readmission
timeFrame: 27 months
measure: Number of participants with 30 day hospital readmission
timeFrame: 27 months
measure: Number of participants with physical therapy use in ICU and post discharge
timeFrame: 27 months
measure: Days with significant pain
timeFrame: 27 months
measure: Number of participants with a reintubation within 24 hours of extubation
timeFrame: 27 months
measure: Number of participants with an unplanned extubation
timeFrame: 27 months
measure: Number of participants with hospital acquired thromboembolic disease
timeFrame: 27 months
measure: Number of participants with a hospital acquired fall with injury
timeFrame: 27 months
measure: Number of participants with a hospital acquired pressure ulcer
timeFrame: 27 months
measure: ICU days with family visit
timeFrame: 27 months
measure: work intensity
timeFrame: 27 months
measure: acceptability
timeFrame: 27 months
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: University of Nebraska
name: Michele C Balas, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: