Nurse-Led Implementation of the ABCDEF Bundle

NCT07054268 | Completed DMC

• 1 other identifier: NURSERC2023/12/10
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluated the effectiveness of a nurse-led implementation of the ABCDEF bundle, an evidence-based, interprofessional care framework, in the prevention and management of delirium among Intensive Care Unit (ICU) patients. The intervention aimed to reduce the incidence and severity of ICU delirium, decrease agitation, and improve patient outcomes through structured nursing interventions guided by the ABCDEF approach.

Conditions

Delirium in the Intensive Care Unit

Keywords

ICU delirium; evidence-based nursing; nursing interventions; critical care; patient outcomes.

Outcome Measures

Primary Outcomes (1)

• Incidence of ICU Delirium

  The presence or absence of delirium will be assessed daily using the Intensive Care Delirium Screening Checklist (ICDSC), a validated tool. Delirium is defined as an ICDSC score ≥4. The outcome will measure the proportion of patients who develop delirium during their ICU stay.

  From ICU admission to ICU discharge or up to 7 days, whichever occurs first

Study Arms (2)

Study Group

EXPERIMENTAL

The study group received a nurse-led implementation of the ABCDEF bundle, which included structured interventions to assess and manage pain, conduct spontaneous awakening and breathing trials, optimize sedation choices, screen for and manage delirium, promote early mobility, and engage family members. ICU nurses delivered the intervention following standardized protocols to ensure consistency and adherence to the bundle components.

Other: Nurse-Led ABCDEF Bundle Implementation

control group

NO INTERVENTION

The control group received standard ICU care as per the hospital's existing protocols. No structured implementation of the ABCDEF bundle was applied, and nursing care followed routine clinical practices without specific emphasis on coordinated bundle elements.

Interventions

Nurse-Led ABCDEF Bundle Implementation OTHER

This intervention is distinguished by its structured, nurse-led delivery of all six components of the ABCDEF bundle, with nurses serving as primary implementers rather than multidisciplinary teams. Unlike other studies that may focus on select elements of the bundle or physician-led application, this study emphasizes standardized nursing protocols and daily documentation to ensure consistent implementation and evaluation across all components specifically targeting delirium prevention and management in ICU patients.

Study Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Critically ill adult patients aged 18 years or older
• Admitted to the ICU at Ain Shams University Hospitals within 48 hours of enrollment
• Clinically stable to undergo assessment and nursing intervention
• Able to provide informed consent personally or via a legally authorized representative
• Both male and female patients included

You may not qualify if:

• Documented cognitive impairment or pre-existing psychiatric illness
• Severe neurological conditions (e.g., advanced stroke, traumatic brain injury)
• Deep sedation level (Richmond Agitation-Sedation Scale \[RASS\] score \< -4)
• Terminal illness requiring palliative or end-of-life care
• Patients who declined participation or did not meet eligibility screening

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University

Helwan, Cairo Governorate, 11731, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Psychiatric and mental health Nursing

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: March 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: July 8, 2025

Record last verified: 2024-03

Locations

EG (1)