- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT06184945
Поведенческие экономические и кадровые стратегии для увеличения внедрения пакета ABCDEF в отделениях интенсивной терапии (BEST-ICU)
Поведенческие экономические и кадровые стратегии для увеличения внедрения пакета ABCDEF в отделениях интенсивной терапии (BEST ICU): рандомизированное контролируемое исследование с ступенчатым клиновым кластером
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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care unit (ICU) and are often initiated and/or exacerbated by known racial and socioeconomic health disparities and outdated mechanical ventilation (MV) liberation and symptom management practices.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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Michele C Balas, PhD, RN
- Номер телефона: (614) 949-5555
- Электронная почта: mibalas@unmc.edu
Учебное резервное копирование контактов
- Имя: Eduard Vasilevskis, MD
- Номер телефона: (608) 261-1571
- Электронная почта: vasilevskis@wisc.edu
Места учебы
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Iowa
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Iowa City, Iowa, Соединенные Штаты, 52242
- Рекрутинг
- University of Iowa Hospitals and Clinics
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Контакт:
- Anna Krupp, PhD, RN
- Номер телефона: (319) 467-1902
- Электронная почта: anna-krupp@uiowa.edu
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Контакт:
- James Blum, MD
- Номер телефона: (319) 678-7116
- Электронная почта: james-blum@uiowa.edu
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Nebraska
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Omaha, Nebraska, Соединенные Штаты, 68198
- Рекрутинг
- University of Nebraska Medical Center
-
Главный следователь:
- Breanna D Hetland, PhD
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Младший исследователь:
- Chris S Wichman, PhD
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Младший исследователь:
- James R Campbell, PhD
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Младший исследователь:
- Ronnie Horner, PHD
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Младший исследователь:
- Jungyoon Kim, PhD
-
Контакт:
- Michele C Balas, PhD, RN
- Номер телефона: (402) 559-9758
- Электронная почта: mibalas@unmc.edu
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43201
- Рекрутинг
- Ohio State University
-
Контакт:
- Tony Gerlach, PHD
- Номер телефона: (614) 688-0234
- Электронная почта: anthony.gerlach@osumc.edu
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Контакт:
- Matthew Exline, MD
- Номер телефона: (614) 293-4925
- Электронная почта: matthew.exline@osumc.edu
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Без вмешательства: Usual care
Usual ICU care |
|
|
Экспериментальный: 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 |
|
Экспериментальный: 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 |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Proportional ABCDEF bundle performance
Временное ограничение: 27 months
|
Defined as the percentage of eligible elements a patient receives on a given ICU day ["bundle dose"]. |
27 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Complete ABCDEF bundle performance
Временное ограничение: 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
Временное ограничение: 27 months
|
Days spent in ICU on invasive mechanical ventilation |
27 months
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Number of participants with new tracheotomy placement
Временное ограничение: 27 months
|
Current Procedural Terminology code for tracheotomy during hospitalization |
27 months
|
|
advanced noninvasive respiratory therapy use and duration
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 27 months
|
Will collect data regarding daily interactions with physical therapy. |
27 months
|
|
Days with significant pain
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 27 months
|
Electronic health record documentation of family visit that occurred during ICU stay |
27 months
|
|
work intensity
Временное ограничение: 27 months
|
6 item National Aeronautics and Space Administration Task Load Index; Higher scores indicate higher work intensity |
27 months
|
|
acceptability
Временное ограничение: 27 months
|
4 item Acceptability of Intervention Measure; higher scores indicate greater acceptability |
27 months
|
Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Michele C Balas, PhD, RN, University of Nebraska
Публикации и полезные ссылки
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 0794-23-FB
- 1UG3HL165740-01A1 (Грант/контракт NIH США)
- 4UH3HL165740-02 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
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.
Сроки обмена IPD
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.
Критерии совместного доступа к IPD
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.
Совместное использование IPD Поддерживающий тип информации
- STUDY_PROTOCOL
- САП
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .