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- Klinische proef NCT06184945
Gedragseconomische en personeelsstrategieën om de adoptie van de ABCDEF-bundel op de ICU te vergroten (BEST-ICU)
Gedragseconomische en personeelsstrategieën om de adoptie van de ABCDEF-bundel op de intensive care (BEST ICU) te vergroten: een gerandomiseerde gecontroleerde studie met getrapte wigclusters
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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care unit (ICU) and are often initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices.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
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Michele C Balas, PhD, RN
- Telefoonnummer: (614) 949-5555
- E-mail: mibalas@unmc.edu
Studie Contact Back-up
- Naam: Eduard Vasilevskis, MD
- Telefoonnummer: (608) 261-1571
- E-mail: vasilevskis@wisc.edu
Studie Locaties
-
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Iowa
-
Iowa City, Iowa, Verenigde Staten, 52242
- Werving
- University of Iowa Hospitals and Clinics
-
Contact:
- Anna Krupp, PhD, RN
- Telefoonnummer: (319) 467-1902
- E-mail: anna-krupp@uiowa.edu
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Contact:
- James Blum, MD
- Telefoonnummer: (319) 678-7116
- E-mail: james-blum@uiowa.edu
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Nebraska
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Omaha, Nebraska, Verenigde Staten, 68198
- Werving
- University of Nebraska Medical Center
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Hoofdonderzoeker:
- Breanna D Hetland, PhD
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Onderonderzoeker:
- Chris S Wichman, PhD
-
Onderonderzoeker:
- James R Campbell, PhD
-
Onderonderzoeker:
- Ronnie Horner, PHD
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Onderonderzoeker:
- Jungyoon Kim, PhD
-
Contact:
- Michele C Balas, PhD, RN
- Telefoonnummer: (402) 559-9758
- E-mail: mibalas@unmc.edu
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Ohio
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Columbus, Ohio, Verenigde Staten, 43201
- Werving
- Ohio State University
-
Contact:
- Tony Gerlach, PHD
- Telefoonnummer: (614) 688-0234
- E-mail: anthony.gerlach@osumc.edu
-
Contact:
- Matthew Exline, MD
- Telefoonnummer: (614) 293-4925
- E-mail: matthew.exline@osumc.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Geen tussenkomst: Usual care
Usual ICU care |
|
|
Experimenteel: 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 |
|
Experimenteel: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Proportional ABCDEF bundle performance
Tijdsspanne: 27 months
|
Defined as the percentage of eligible elements a patient receives on a given ICU day ["bundle dose"]. |
27 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Complete ABCDEF bundle performance
Tijdsspanne: 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
Tijdsspanne: 27 months
|
Days spent in ICU on invasive mechanical ventilation |
27 months
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of participants with new tracheotomy placement
Tijdsspanne: 27 months
|
Current Procedural Terminology code for tracheotomy during hospitalization |
27 months
|
|
advanced noninvasive respiratory therapy use and duration
Tijdsspanne: 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.
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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 27 months
|
Will collect data regarding daily interactions with physical therapy. |
27 months
|
|
Days with significant pain
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 27 months
|
Electronic health record documentation of family visit that occurred during ICU stay |
27 months
|
|
work intensity
Tijdsspanne: 27 months
|
6 item National Aeronautics and Space Administration Task Load Index; Higher scores indicate higher work intensity |
27 months
|
|
acceptability
Tijdsspanne: 27 months
|
4 item Acceptability of Intervention Measure; higher scores indicate greater acceptability |
27 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Michele C Balas, PhD, RN, University of Nebraska
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 0794-23-FB
- 1UG3HL165740-01A1 (Subsidie/contract van de Amerikaanse NIH)
- 4UH3HL165740-02 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-tijdsbestek voor delen
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.
IPD-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
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