Behavioral Economic & Staffing Strategies to Increase Adoption of ABCDEF Bundle in the ICU

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care unit (ICU) and are often initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices.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

Official Title
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Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the Intensive Care Unit (BEST ICU): A Stepped Wedge Cluster Randomized Controlled Trial

Conditions
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Implementation Science, Delirium, Critical Illness, Mechanical Ventilation Complication, ICU Acquired Weakness, Pain

Intervention / Treatment
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* Behavioral: Realtime audit and feedback
* Behavioral: RN Implementation Facilitator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: pragmatic, stepped-wedge, cluster-randomized, hybrid type III effectiveness-implementation trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>Usual ICU care | |
| Experimental: Audit and Feedback<br>ICUs receive electronic dashboard that display realtime ABCDEF bundle performance data | Behavioral: Realtime audit and feedback<br>* ICUs randomized to this arm will receive and electronic dashboard that displays realtime ABCDEF bundle performance data<br>|
| Experimental: RN Implementation Facilitator<br>ICUs receive a extra RN who help facilitate ABCDEF bundle implementation | Behavioral: RN Implementation Facilitator<br>* ICUs randomized to this arm will receive a RN who will assist with ABCDEF bundle implementation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportional ABCDEF bundle performance | Defined as the percentage of eligible elements a patient receives on a given ICU day [bundle dose]. | 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete ABCDEF bundle performance | Defined as a patient-day in which every eligible element of the bundle was performed (i.e., 100% of the bundle versus anything less; yes/no). | 27 months | 
| Duration of mechanical ventilation | Days spent in ICU on mechanical ventilation | 27 months |