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NCT Number: NCT06184945

Behavioral Economic & Staffing Strategies in the ICU

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals and Clinics, Iowa City, Iowa, United States

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About this study

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care unit (ICU) and are often initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Realtime audit and feedback

Behavioral

ICUs randomized to this arm will receive and electronic dashboard that displays realtime ABCDEF bundle performance data

RN Implementation Facilitator

Behavioral

ICUs randomized to this arm will receive a RN who will assist with ABCDEF bundle implementation

Primary outcomes

  1. Proportional ABCDEF bundle performance

    Time frame: 27 months

    Defined as the percentage of eligible elements a patient receives on a given ICU day ["bundle dose"].

Secondary outcomes

  1. Complete ABCDEF bundle performance

    Time frame: 27 months

    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).

  2. Duration of invasive mechanical ventilation

    Time frame: 27 months

    Days spent in ICU on invasive mechanical ventilation

Other outcomes

  1. Number of participants with new tracheotomy placement

    Time frame: 27 months

    Current Procedural Terminology code for tracheotomy during hospitalization

  2. advanced noninvasive respiratory therapy use and duration

    Time frame: 27 months

    The recorded timestamps for advanced non-invasive respiratory therapy using CPAP, BiLevel Positive Pressure Ventilation (BiPaP), or high flow cannula with oxygen flow rates >20 lpm using a face mask or other airway that is NOT an endotracheal tube will be monitored. Specific data elements in the EHR relevant to advanced non-invasive respiratory therapy will be examined. This may include.

    • Clinical orders for the initiation of BiPaP
    • Respiratory therapy logs of pressure setting management
    • Ventilator settings and parameters recorded over time.

    Once the data is organized, the duration of advanced non-invasive respiratory therapy for each patient will be calculated using the following formula:

    Duration (in hours) = CPAP/BiPaP/High Flow Oxygen Initiation Time - CPAP/BiPaP/High Flow OxygenTermination Time

  3. Number of participants with an ICU mortality

    Time frame: 27 months

    A death event that is recorded in the electronic health record (EHR) that occurred after index ICU admission and prior to the index ICU discharge date and time

  4. Number of participants with a hospital mortality

    Time frame: 27 months

    A death event that is recorded in the EHR that occurred after index ICU admission and prior to discharge from the hospital on the index hospital stay.

  5. Number of participants who die within 30 days of hospital discharge

    Time frame: 27 months

    A death event that is recorded in the EHR that occurs within 30 days of the date of hospital discharge from the index hospital stay.

  6. ICU length of stay (LOS)

    Time frame: 27 months

    Date and time of ICU discharge minus the date and time of ICU admission. Each ICU stay will be recorded as unique ICU stays as a unique ICU encounter.

  7. hospital LOS

    Time frame: 27 months

    Date and time of hospital discharge minus the date and time of first encounter during the hospital encounter

  8. ICU days with acute brain dysfunction

    Time frame: 27 months

    Will record ICU days with delirium. A delirious day would include a 24-hour period with at least one Confusion Assessment Method ICU (CAM ICU) score that is measured as positive. The total would include the total number of days for which CAM ICU is measured to be positive. ICU coma days: Will record any day for which patients exhibit level of arousal scores consistent with coma (Richmond agitation/sedation score -4 or -5, Sedation agitation score of 1 or 2) and add the total number of coma days throughout any given ICU stay, and across all ICU stays within a hospitalization.

  9. ICU days with physical restraint use

    Time frame: 27 months

    Physical restraint status codes will be identified using the International Classification of Disease code Z78.1 "physical restraint status".

  10. Opioid, benzodiazepine, sedative/hypnotic, and antipsychotic medication use in ICU and at hospital discharge

    Time frame: 27 months

    Opioid, benzodiazepine, sedative/hypnotic, antipsychotic medication, and melatonin receptor agonist medication use in ICU and at hospital discharge as recorded in EHR

  11. Discharge destination

    Time frame: 27 months

    Will review hospital discharge destination coded as home, home with home health, short term skilled nursing facility, long term nursing facility, acute rehabilitation hospital, long-term acute care hospital, hospice, acute care hospital, death.

  12. Number of participants with an ICU readmission

    Time frame: 27 months

    Will be coded yes if a patient has at least one readmission to any ICU following discharge from the index ICU stay.

  13. Number of participants with 30 day hospital readmission

    Time frame: 27 months

    Coded yes if a patient has at least one hospital readmission following discharge from the index hospital stay. Importantly, will only be able to track same-hospital readmissions.

  14. Number of participants with physical therapy use in ICU and post discharge

    Time frame: 27 months

    Will collect data regarding daily interactions with physical therapy.

  15. Days with significant pain

    Time frame: 27 months

    Will define an ICU Day as having an episode of significant pain if any of the below are documented; Numeric rating score: A score of > 7 will be considered significant pain; critical care pain observation tool: A score > 2 will be considered significant pain; Behavioral pain scale: A score > 5 will be considered significant pain; Defense and Veterans Pain Rating Scale: A score > 4 will be considered significant pain; Pain in Alzheimer Disease score: A score > 4 will be considered significant pain

  16. Number of participants with a reintubation within 24 hours of extubation

    Time frame: 27 months

    Will assess for evidence of an order for intubation that occurs < 24 hours following evidence of extubation, or a prior order for extubation.

  17. Number of participants with an unplanned extubation

    Time frame: 27 months

    Will assess for evidence of extubations that do not follow provider orders for an extubation and/or are charted as unordered.

  18. Number of participants with hospital acquired thromboembolic disease

    Time frame: 27 months

    Will query for International Classification of Disease codes associated with thromboembolic disease. Diagnosis codes must be a secondary diagnosis code / hospital acquired

  19. Number of participants with a hospital acquired fall with injury

    Time frame: 27 months

    Will record fall and trauma coding consistent with the Center for Medicare Services Health Acquired Conditions specification for fracture, dislocation, and intracranial injury.

  20. Number of participants with a hospital acquired pressure ulcer

    Time frame: 27 months

    The codes for hospital acquired pressure ulcer will be consistent with the Center for Medicare Services Hospital Acquired Conditions coding.

  21. ICU days with family visit

    Time frame: 27 months

    Electronic health record documentation of family visit that occurred during ICU stay

  22. work intensity

    Time frame: 27 months

    6 item National Aeronautics and Space Administration Task Load Index; Higher scores indicate higher work intensity

  23. acceptability

    Time frame: 27 months

    4 item Acceptability of Intervention Measure; higher scores indicate greater acceptability

Study contacts

Contact information is provided by the study sponsor or research team.

Eduard Vasilevskis, MD

CONTACT

[email protected]

(608) 261-1571

Michele C Balas, PhD, RN

CONTACT

[email protected]

(614) 949-5555

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • Ohio State University
  • University of Iowa
  • University of Wisconsin, Madison

Registry information

Official study 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

Acronym: BEST-ICU

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 29, 2023
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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