Nurse-Led Implementation of the ABCDEF Bundle

NCT ID: NCT07054268

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2024-09-30

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.

Detailed Description

The study employed a single-center, quasi-experimental clinical design with two parallel groups: an intervention group that received the nurse-led ABCDEF bundle and a control group that received standard ICU care. No randomization was applied, but baseline characteristics were matched where possible to control for confounding variables.

The study was conducted in the adult ICU of a tertiary care hospital. Eligible participants included adult patients (≥18 years) who were admitted to the ICU with an expected stay of at least 48 hours. Patients with pre-existing cognitive impairment, severe neurological damage, or those in a persistent vegetative state were excluded.

The intervention group received structured nursing care guided by the ABCDEF bundle, delivered by trained ICU nurses. The protocol included routine pain assessments and management strategies; daily spontaneous awakening and breathing trials; evidence-based sedation choices minimizing benzodiazepine use; systematic delirium screening using a validated tool (e.g., ICDSC); early mobilization practices appropriate to the patient's clinical status; and inclusion of family members in care planning and education.

The control group received usual ICU care without the formal implementation of the ABCDEF bundle.

The primary outcome was the incidence of delirium during the ICU stay, measured using a validated tool (e.g., ICDSC or CAM-ICU). Secondary outcomes included agitation levels, duration of delirium episodes, ICU length of stay, adherence to individual ABCDEF components, use of physical restraints, and sedative/analgesic dosages.

Data were collected prospectively from patient medical records, bedside observations, and standardized assessment tools. Daily monitoring was conducted to ensure fidelity to the intervention and accurate documentation of outcomes.

Ethical approval was obtained from the institutional review board. Written informed consent was obtained from patients or their legal representatives where applicable.

Conditions

Delirium in the Intensive Care Unit

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Study Group

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.

Group Type: EXPERIMENTAL

Nurse-Led ABCDEF Bundle Implementation

Intervention Type: 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.

control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Nurse-Led ABCDEF Bundle Implementation

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helwan University

OTHER

Sponsor Role: lead

Responsible Party

Alaa Eldin Moustafa Hamed

Lecturer of Psychiatric and mental health Nursing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Helwan University

Helwan, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

NURSERC2023/12/10

Identifier Type: -

Identifier Source: org_study_id