NCT06184945

Behavioral Economic & Staffing Strategies in the ICU

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,100 (estimated)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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care unit (ICU) and are often initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices.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

Interventions

Type	Name	Description
BEHAVIORAL	Realtime audit and feedback	ICUs randomized to this arm will receive and electronic dashboard that displays realtime ABCDEF bundle performance data
BEHAVIORAL	RN Implementation Facilitator	ICUs randomized to this arm will receive a RN who will assist with ABCDEF bundle implementation

Timeline

• Start date: 2024-07-01
• Primary completion: 2028-04-01
• Completion: 2028-04-01
• First posted: 2023-12-29
• Last updated: 2026-02-19

Locations

3 sites across 1 country: United States