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Background <p>Despite its proven safety and effectiveness at liberation from mechanical ventilation, ABCDEF (Assess, prevent, and manage pain; Both spontaneous awakening and breathing trials; Choice of analgesia/sedation; Delirium: assess, prevent, and manage; Early mobility/exercise; and Family engagement/empowerment) bundle performance in everyday intensive care unit (ICU) practice remains disappointingly low. This evidence-to-practice gap significantly contributes to the excessively high morbidity, mortality, costs, and disparities associated with current critical care delivery. This study will evaluate the effects of two discrete, behavioral economic, and implementation science-based strategies on ABCDEF bundle adoption and patient-centered outcomes.</p> Methods <p>The Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the ICU (BEST-ICU) study is a three-arm pragmatic, stepped-wedged, cluster-randomized hybrid type 3 effectiveness-implementation trial aimed at detecting superiority of real-time audit and feedback (A&amp;F) via an electronic dashboard versus registered nurse (RN) implementation facilitation on proportional ABCDEF bundle performance (primary implementation outcome), complete ABCDEF bundle performance (secondary outcome), and duration of invasive mechanical ventilation (secondary outcome). The study will include 8100 patients admitted to 12 ICUs from 3 discrete safety net hospitals. Patients included will be ≥ 19&#xa0;years old, admitted to a participating ICU for at least 24&#xa0;h, and have received invasive mechanical ventilation during their ICU stay. All bundle performance and clinical outcome data on patients will be captured via institutional electronic health records (EHR). During the 27-month study, participating ICUs will be randomly assigned to either real-time A&amp;F or an RN implementation facilitation using a two-step, stratified randomization process. At the study’s end, both strategies will be removed (i.e., unless ICUs independently decide to continue the strategy), while implementation and clinical outcomes are followed for an additional 3 months, and key stakeholders’ experiences with, and perspectives of, real-time A&amp;F and RN implementation facilitation are explored.</p> Discussion <p>Using a novel study design while building upon currently available EHR technology and established patient-centered outcomes research network capability, the BEST ICU study will be the first translational research trial specifically aimed at developing and testing theory-based, clinician-informed, pragmatic, and potentially sustainable ABCDEF bundle implementation strategies.</p> Trial registration <p>ClinicalTrials.gov NCT 06184945. Registered on December 13, 2023</p>

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Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the Intensive Care Unit (BEST ICU): study protocol for a multi-site stepped-wedge cluster randomized controlled trial in the USA

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年12月12日

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  • Eduard E. Vasilevskis,
  • Jungyoon Kim,
  • Christopher Wichman,
  • Ronnie Horner,
  • James R. Campbell,
  • Carol Reynolds Geary,
  • Justin Birge,
  • Breanna Hetland,
  • Ann Blanchard,
  • Katie Circo,
  • Amberly Wagner-Connolly,
  • Jennifer Miller,
  • Matthew C. Exline,
  • Anthony T. Gerlach,
  • Anna Krupp,
  • James Blum,
  • Michele C. Balas

摘要

Background

Despite its proven safety and effectiveness at liberation from mechanical ventilation, ABCDEF (Assess, prevent, and manage pain; Both spontaneous awakening and breathing trials; Choice of analgesia/sedation; Delirium: assess, prevent, and manage; Early mobility/exercise; and Family engagement/empowerment) bundle performance in everyday intensive care unit (ICU) practice remains disappointingly low. This evidence-to-practice gap significantly contributes to the excessively high morbidity, mortality, costs, and disparities associated with current critical care delivery. This study will evaluate the effects of two discrete, behavioral economic, and implementation science-based strategies on ABCDEF bundle adoption and patient-centered outcomes.

Methods

The Behavioral Economic and Staffing Strategies To Increase Adoption of the ABCDEF Bundle in the ICU (BEST-ICU) study is a three-arm pragmatic, stepped-wedged, cluster-randomized hybrid type 3 effectiveness-implementation trial aimed at detecting superiority of real-time audit and feedback (A&F) via an electronic dashboard versus registered nurse (RN) implementation facilitation on proportional ABCDEF bundle performance (primary implementation outcome), complete ABCDEF bundle performance (secondary outcome), and duration of invasive mechanical ventilation (secondary outcome). The study will include 8100 patients admitted to 12 ICUs from 3 discrete safety net hospitals. Patients included will be ≥ 19 years old, admitted to a participating ICU for at least 24 h, and have received invasive mechanical ventilation during their ICU stay. All bundle performance and clinical outcome data on patients will be captured via institutional electronic health records (EHR). During the 27-month study, participating ICUs will be randomly assigned to either real-time A&F or an RN implementation facilitation using a two-step, stratified randomization process. At the study’s end, both strategies will be removed (i.e., unless ICUs independently decide to continue the strategy), while implementation and clinical outcomes are followed for an additional 3 months, and key stakeholders’ experiences with, and perspectives of, real-time A&F and RN implementation facilitation are explored.

Discussion

Using a novel study design while building upon currently available EHR technology and established patient-centered outcomes research network capability, the BEST ICU study will be the first translational research trial specifically aimed at developing and testing theory-based, clinician-informed, pragmatic, and potentially sustainable ABCDEF bundle implementation strategies.

Trial registration

ClinicalTrials.gov NCT 06184945. Registered on December 13, 2023