Nurse-Led Implementation of the ABCDEF Bundle (NCT07054268) | Clinical Trial Compass
CompletedNot Applicable
Nurse-Led Implementation of the ABCDEF Bundle
Egypt140 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of ICU Delirium
Timeframe: From ICU admission to ICU discharge or up to 7 days, whichever occurs first