NCT07759310 ICU Delirium Playbook Training Study for ICU Nurses
| NCT ID | NCT07759310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nicola Pagnucci |
| Condition | Nursing Education |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2026-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-10-01 with a primary completion date of 2026-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Delirium is a common and serious acute neurocognitive disorder among critically ill patients, affecting up to 50% of intensive care unit (ICU) patients and up to 80-90% of those receiving invasive mechanical ventilation. It is associated with increased mortality, prolonged ICU and hospital length of stay, long-term cognitive impairment, higher healthcare costs, and reduced quality of life for patients and their families. Despite the availability of validated screening tools such as the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), delirium remains underrecognized and undertreated in routine clinical practice, largely because of inadequate healthcare professional education and inconsistent implementation of evidence-based recommendations. Nurses play a central role in the prevention, early detection, and management of delirium, making targeted educational interventions essential to improve clinical practice. The ICU Delirium Playbook is a multimedia educational program developed by the University of California, San Diego, consisting of brief instructional videos and realistic clinical scenarios designed to improve nurses' knowledge and confidence in delirium assessment and management. The aim of this quasi-experimental pre-post study is to evaluate the effectiveness of the ICU Delirium Playbook among intensive care nurses at Pisa University Hospital. The primary objective is to determine whether participation in the educational program improves nurses' knowledge of delirium. Secondary objectives are to evaluate participants' satisfaction with the training, assess changes in clinical attitudes and behaviors related to delirium care, validate the Italian version of the behavioral assessment questionnaire, and explore the impact of the educational intervention on patient outcomes, including the frequency of delirium recognition and the duration of delirium episodes. The study will be conducted in a single center using a pre-intervention and post-intervention design. Before the educational intervention, participating nurses will complete questionnaires evaluating delirium knowledge, attitudes, and clinical behaviors. During the same period, retrospective and prospective clinical data will be collected from medical records of adult patients admitted to the Cardio-Thoracic-Vascular Intensive Care Unit, including delirium assessment and diagnosis. Following baseline data collection, nurses will attend the ICU Delirium Playbook educational session, lasting approximately four hours. After completion of the videos, nurses will repeat the same questionnaires, and patient clinical data will be collected again during a six-month post-intervention period. The study is based on Kirkpatrick's Four-Level Model for training evaluation, assessing participants' reaction to the educational intervention, learning outcomes, behavioral changes in clinical practice, and the effects on patient care. It is expected that the intervention will improve nurses' knowledge and evidence-based management of delirium, increase the recognition of delirium in ICU patients. The findings of this study will provide evidence regarding the effectiveness of the ICU Delirium Playbook in the Italian critical care setting and may support the implementation of standardized delirium education programs in intensive care units.
Eligibility Criteria
Inclusion Criteria: * nurses working in the ICU of the Pisa University Hospital (AOUP). * nurses with at least 12 months of professional experience in intensive care. Exclusion Criteria: -Nurses who do not provide informed consent
Contact & Investigator
Nicola Pagnucci, RN, MSN, PhD
STUDY DIRECTOR
University of Pisa
Frequently Asked Questions
Who can join the NCT07759310 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Nursing Education. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07759310 currently recruiting?
Yes, NCT07759310 is actively recruiting participants. Contact the research team at nicola.pagnucci@unipi.it for enrollment information.
Where is the NCT07759310 trial being conducted?
This trial is being conducted at Pisa, Italy.
Who is sponsoring the NCT07759310 clinical trial?
NCT07759310 is sponsored by Nicola Pagnucci. The principal investigator is Nicola Pagnucci, RN, MSN, PhD at University of Pisa. The trial plans to enroll 60 participants.