Clinical trial NCT01413009: Awakening-Breathing Coordination, Delirium Monitoring/Management & Early Mobility (ABCDE) Protocol
Official title: Awakening-Breathing Coordination, Delirium Monitoring/Management & Early Mobility (ABCDE) Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ICU Delirium
Immobility
Keywords: delirium
ICU
spontaneous awakening trials
spontaneous breathing trials
early mobility
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Robert Wood Johnson Foundation
First posted: 2011-08-09
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critical care services

Brief summary: Fully two-thirds of ICU patients develop delirium, which is associated with longer stays, billions of dollars in costs globally, and 3-fold excess mortality at 6 months. Over one-half of ICU survivors suffer a functionally debilitating dementia-like illness, which appears related to delirium duration. This study will focus on applying Awakening-Breathing Coordination, Delirium Monitoring/Management \& Early Mobility (ABCDE), a program of delirium screening, prevention, and treatment developed at Vanderbilt University. Specifically, the study will implement the ABCDE program in a medical center that does not currently perform routine ICU delirium screenings and identify facilitators and barriers to program adoption; test the impact of the ABCDE program on patient outcomes, nursing quality outcomes, and system outcomes; and assess the extent to which ABCDE implementation is effective, sustainable, and conducive to dissemination into other settings.

Detailed description: We face a profound and emerging public health problem in the form of acute and chronic brain dysfunction among young and elderly intensive care unit (ICU) survivors that is altering the landscape of society. Fully two-thirds of ICU patients develop delirium, which is associated with longer stays, billions of dollars in costs globally, and 3-fold excess mortality at 6 months. Over one-half of ICU survivors suffer a functionally debilitating dementia-like illness, which appears related to delirium duration. The impact on a person's life is often devastating. The main goal of the proposed INQRI project is to implement, analyze, and disseminate an evidence-based, nurse-led, inter-professional, multi-component program focused on improving the care and outcomes of critically ill adults. The study will focus on applying Awakening-Breathing Coordination, Delirium Monitoring/Management \& Early Mobility (ABCDE), a program of delirium screening, prevention, and treatment developed at Vanderbilt University. The ABCDE approach analyzes and merges the best available evidence related to delirium, analgesia, and sedation (DAS) management in the ICU and tailors the pharmacologic and nonpharmacologic interventions used in prior DAS clinical trials into a program that can be adopted into practice in less "research focused" ICUs. Specifically, the study aims are to (1) implement the ABCDE program in a medical center that does not currently perform routine ICU delirium screenings and identify facilitators and barriers to program adoption; (2) test the impact of the ABCDE program on patient outcomes, nursing quality outcomes, and system outcomes; and (3) assess the extent to which ABCDE implementation is effective, sustainable, and conducive to dissemination into other settings.

Eligibility criteria: Inclusion Criteria:

* Greater than or equal to 19 years of age
* Patients at the University of Nebraska Medical Center and the Nebraska Medical Center
* Admitted to either the academic medical or trauma critical care service

Exclusion Criteria:

* Legally authorized representative not available to provide consent to participate within 48 hours of ICU admission

Primary outcomes:
measure: Ventilator free days (VFDs)
timeFrame: Change in ventlator free days at baseline to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Michele Balas, PhD
role: PRINCIPAL_INVESTIGATOR
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