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Completed

NCT Number: NCT01413009

Awakening-Breathing Coordination, Delirium Monitoring/Management & Early Mobility (ABCDE) Protocol

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Ventilator free days (VFDs)

    Time frame: Change in ventlator free days at baseline to 9 months

    The primary outcome will be a comparison between the 3 month baseline period of ventilator free days and the 9 month period following the intervention. Two interim analyses will be conducted.

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Acronym: ABCDE

Important dates

Study start
2010
Primary completion
2012
Study completion
2013
First posted
Aug 9, 2011
Registry last updated
Sep 15, 2023

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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