Trial Summary

Survivors of critical illness frequently experience profound physical, mental, and cognitive health impairments that are initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated intensive care unit (ICU) mechanical ventilation and symptom management practices. This morbidity is potentially preventable through the application of the ABCDEF bundle, a multicomponent, evidence-based intervention to improve team-based care. While consistently proven safe and effective, national ABCDEF bundle performance remains unacceptably low as clinicians continue to struggle with multiple barriers to bundle delivery. The long-term goal of BEST-ICU is to develop pragmatic and sustainable strategies to increase the delivery of evidence-based practices that lead to improved care for critically ill adults across a variety of healthcare systems, particularly those serving populations with known health disparities, such as safety net hospitals. The overall objective of BEST-ICU is to evaluate 2 strategies grounded in behavioral economic theory and implementation science to increase ABCDEF bundle adoption. The strategies being evaluated target a variety of ICU team members and known behavioral determinants of bundle performance. The project includes 2 phases and 4 aims. In the UG3 planning phase, the study team will work with the NIH Pragmatic Trials Collaboratory Coordinating Center and community partners to meet key milestones aimed at enhancing and finalizing the implementation strategies and research methods used to facilitate and evaluate the effectiveness of ABCDEF bundle adoption. In the UH3 implementation phase, the study team will conduct a pragmatic, stepped-wedge, cluster randomized hybrid type III effectiveness-implementation trial. After creating 6 matched pairs of 12 ICUs from 3 hospitals (N = 8100 patients on mechanical ventilation), the study team will randomly assign ICUs within each matched pair to receive either real-time audit and feedback (Strategy A) or a registered nurse implementation facilitator (Strategy B) and each pair to 1 of 6 wedges. The aims of the trial are to compare the effectiveness of real-time audit and feedback and the implementation facilitator on ABCDEF bundle adoption (the primary outcome) and clinical outcomes (including duration of mechanical ventilation; ICU, hospital, and 30-day mortality; ICU and hospital length of stay; days with acute brain dysfunction; discharge disposition, psychoactive medication, and physical therapy utilization; and 30-day hospital readmission). Finally, the study will identify and describe key stakeholders' experiences with, and perspectives on, the acceptability and impact on workload of the implementation strategies. The study results are expected to impact the field by developing simple, yet effective, ways of accelerating the reliable uptake of a variety of evidence-based ICU interventions that will address known health disparities in the ICU and ultimately improve the care and outcomes of millions of critically ill adults annually.

NIH Project Information