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

NCT ID: NCT01413009

Last Updated: 2023-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-29
• Study Completion Date: 2013-06-01

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.

Conditions

ICU Delirium; Immobility

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

ICU patients

Adult patients admitted to the University of Nebraska Medical Center or the Nebraska Medical Center trauma critical care service.

No interventions assigned to this group

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Robert Wood Johnson Foundation

OTHER

Sponsor Role: collaborator

University of Nebraska

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michele Balas, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

University of Nebraska Medical Center

Omaha, Nebraska, United States

Countries

United States

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Pandharipande PP, Pun BT, Herr DL, Maze M, Girard TD, Miller RR, Shintani AK, Thompson JL, Jackson JC, Deppen SA, Stiles RA, Dittus RS, Bernard GR, Ely EW. Effect of sedation with dexmedetomidine vs lorazepam on acute brain dysfunction in mechanically ventilated patients: the MENDS randomized controlled trial. JAMA. 2007 Dec 12;298(22):2644-53. doi: 10.1001/jama.298.22.2644.

Reference Type: BACKGROUND

PMID: 18073360 (View on PubMed)

Other Identifiers

0590-10-FB

Identifier Type: -

Identifier Source: org_study_id