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Atferdsøkonomiske og bemanningsstrategier for å øke bruken av ABCDEF-pakke i intensivavdelingen (BEST-ICU)

19. oktober 2026 oppdatert av: University of Nebraska

Atferdsøkonomiske strategier og bemanningsstrategier for å øke bruken av ABCDEF-pakken i intensivavdelingen (BEST ICU): A Stepped Wedge Cluster Randomized Controlled Trial

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.

Studieoversikt

Detaljert beskrivelse

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care unit (ICU) and are often initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices.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=16,500 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, and paralytic 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.

Studietype

Intervensjonell

Registrering (Antatt)

16500

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Michele C Balas, PhD, RN
  • Telefonnummer: (614) 949-5555
  • E-post: mibalas@unmc.edu

Studer Kontakt Backup

Studiesteder

    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • Rekruttering
        • University of Iowa Hospitals and Clinics
        • Ta kontakt med:
        • Ta kontakt med:
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68198
        • Rekruttering
        • University of Nebraska Medical Center
        • Hovedetterforsker:
          • Breanna D Hetland, PhD
        • Underetterforsker:
          • Chris S Wichman, PhD
        • Underetterforsker:
          • James R Campbell, PhD
        • Underetterforsker:
          • Ronnie Horner, PHD
        • Underetterforsker:
          • Jungyoon Kim, PhD
        • Ta kontakt med:
          • Michele C Balas, PhD, RN
          • Telefonnummer: (402) 559-9758
          • E-post: mibalas@unmc.edu
    • Ohio
      • Columbus, Ohio, Forente stater, 43201

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

19 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Age > or = to 19 years at time of ICU admission
  • Received invasive mechanical ventilation while in a cluster ICU
  • Admitted to participating cluster ICU
  • Cluster 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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Usual care

Usual ICU care

Eksperimentell: Audit and Feedback

ICUs receive electronic dashboard that displays realtime ABCDEF bundle performance data

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

Eksperimentell: RN Implementation Facilitator

ICUs receive a extra RN who helps facilitate ABCDEF bundle implementation

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Proportional ABCDEF bundle performance
Tidsramme: 27 months

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

27 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Complete ABCDEF bundle performance
Tidsramme: 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).

27 months
Duration of invasive mechanical ventilation
Tidsramme: 27 months

Days spent in ICU on invasive mechanical ventilation

27 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with new tracheotomy placement
Tidsramme: 27 months

Current Procedural Terminology code for tracheotomy during hospitalization

27 months
advanced noninvasive respiratory therapy use and duration
Tidsramme: 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

27 months
Number of participants with an ICU mortality
Tidsramme: 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

27 months
Number of participants with a hospital mortality
Tidsramme: 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.

27 months
Number of participants who die within 30 days of hospital discharge
Tidsramme: 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.

27 months
ICU length of stay (LOS)
Tidsramme: 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.

27 months
hospital LOS
Tidsramme: 27 months

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

27 months
ICU days with acute brain dysfunction
Tidsramme: 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.

27 months
ICU days with physical restraint use
Tidsramme: 27 months

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

27 months
Opioid, benzodiazepine, sedative/hypnotic, and antipsychotic medication use in ICU and at hospital discharge
Tidsramme: 27 months

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

27 months
Discharge destination
Tidsramme: 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.

27 months
Number of participants with an ICU readmission
Tidsramme: 27 months

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

27 months
Number of participants with 30 day hospital readmission
Tidsramme: 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.

27 months
Number of participants with physical therapy use in ICU and post discharge
Tidsramme: 27 months

Will collect data regarding daily interactions with physical therapy.

27 months
Days with significant pain
Tidsramme: 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

27 months
Number of participants with a reintubation within 24 hours of extubation
Tidsramme: 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.

27 months
Number of participants with an unplanned extubation
Tidsramme: 27 months

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

27 months
Number of participants with hospital acquired thromboembolic disease
Tidsramme: 27 months

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

27 months
Number of participants with a hospital acquired fall with injury
Tidsramme: 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.

27 months
Number of participants with a hospital acquired pressure ulcer
Tidsramme: 27 months

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

27 months
ICU days with family visit
Tidsramme: 27 months

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

27 months
work intensity
Tidsramme: 27 months

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

27 months
acceptability
Tidsramme: 27 months

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

27 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Michele C Balas, PhD, RN, University of Nebraska

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2024

Primær fullføring (Antatt)

1. april 2028

Studiet fullført (Antatt)

1. april 2028

Datoer for studieregistrering

Først innsendt

5. desember 2023

Først innsendt som oppfylte QC-kriteriene

13. desember 2023

Først lagt ut (Faktiske)

29. desember 2023

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

19. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

To support study replication and extension, all scientific data including operations and clinical data necessary for replication of this project will be made available in de-identified form before publication, or by the end of the funded period (whichever comes first) in an appropriate online repository. Data used for analysis will be stored in comma-separated values file format to aid in the reuse of collected and analyzed data. Both clinical locations and patient information will be de-identified. All HIPAA identifiers will be removed and low counts will be masked as well. Original data will be maintained at the principal investigator's institution . There will be no restriction to sharing the data.

IPD-delingstidsramme

To support study replication and extension, all scientific data including operations and clinical data necessary for replication of this project will be made available in de-identified form before publication, or by the end of the funded period (whichever comes first) in an appropriate online repository. Data used for analysis will be stored in comma separated values format to aid in the reuse of collected and analyzed data. Both clinical locations and patient information will be de-identified. All HIPAA identifiers will be removed and low counts will be masked. Original data will be maintained at the principal investigator's institution . There will be no restriction to sharing the data.

Tilgangskriterier for IPD-deling

To support study replication and extension, all scientific data, including operational and clinical data necessary for replicating this project, will be made available in de-identified form before publication, or by the end of the funded period (whichever comes first), in an appropriate online repository. Data used for analysis will be stored in comma-separated values format to aid in the reuse of collected and analyzed data. Both clinical locations and patient information will be de-identified. All HIPAA identifiers will be removed and low counts will be masked. Original data will be maintained at the principal investigator's institution. There will be no restriction to sharing the data.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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