An interventional study of ICU Delirium PlayBook educational program in Nursing Education, Delirium Confusional State and ICU, sponsored by Nicola Pagnucci. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Nicola Pagnucci · Not applicable, Interventional, and Other
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.
933 studies on the registry are indexed under Delirium; 190 are open to participants now.
This study's planned enrollment of 60 is below the median of 112 across 550 interventional studies indexed under Delirium.
Browse Delirium studies →This is the only study on the registry with Nicola Pagnucci as lead sponsor.
Compared within Delirium, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Confusion. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
-Nurses who do not provide
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ICU nurses participating in the study will receive a structured educational intervention based on the ICU Delirium PlayBook, a multimedia training program consisting of video-based modules focused on delirium prevention, identification, and management using the CAM-ICU tool. Outcomes including knowledge, attitudes, and clinical practice related to delirium assessment will be measured before the intervention and at 6 months follow-up. In parallel, clinical data will be collected from medical records of ICU patients during both the pre-intervention and post-intervention periods to evaluate delirium incidence and recognition rates by staff nurse. These patient-level outcomes will be used to assess changes in clinical practice following the educational intervention.
Behavioral: ICU Delirium PlayBook educational program
This intervention consists of a structured educational program for intensive care unit nurses based on the ICU Delirium PlayBook. The program includes a series of short multimedia videos (approximately 5-8 minutes each) covering theoretical concepts of delirium, risk factors, prevention strategies, and practical guidance on the use of the CAM-ICU tool for delirium assessment. The training is delivered in a single in-person session lasting approximately 4 hours and integrates clinical scenarios to support applied learning. The aim is to improve nurses' knowledge, attitudes, and clinical practices regarding delirium recognition and management in critically ill patients.
Knowledge acquisition related to Delirium managment
Delirium knowledge will be measured using the ICU Delirium Playbook Quiz, a 44-item multiple-choice questionnaire assessing nurses' knowledge of delirium prevention, recognition, assessment, and management. The score will be calculated as the number of correct answers, with a possible range from 0 to 44 points. The outcome will be reported as the change in total knowledge score from baseline (pre-training) to immediately after the training intervention.
Time frame: Pre-intervention (T0), Immediately post-intervention (T1), and at 6 months (T2)
Evaluation of participants' satisfaction
Participants' satisfaction will be measured using the institutional course evaluation questionnaire administered through the hospital's educational platform. The questionnaire assesses the perceived relevance of the topics covered, educational quality of the course program, usefulness of the educational intervention, organizational quality, presence of conflicts of interest, and quality of teaching. Responses will be reported according to the response scale used in the institutional questionnaire.
Time frame: Immediately post intervention
To assess the application of the acquired knowledge in clinical practice
Nurses' attitudes toward delirium will be measured using the Assessment of Nurses' Attitudes Toward Delirium (ADoT). The ADoT is a self-report instrument designed to assess nurses' attitudes toward delirium and its management in clinical practice. The outcome will be reported as the change in ADoT score from baseline (pre-training) to post-training.
Time frame: Pre-intervention (T0), Immediately post-intervention (T1), and at 6 months (T2)
To evaluate patient outcomes in terms of increased delirium recognition by ICU nurses
The implementation of delirium assessment in clinical practice will be measured by reviewing patients' clinical records and recording the number of delirium assessments performed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
Time frame: Pre-intervention (T0) and post-intervention (T1) until the target sample size is achieved.
Questionnaire Validation
This objective aims to translate, culturally adapt, and validate the Italian version of the educational questionnaire used to measure behavioral changes, ensuring its reliability and validity.
Time frame: During the study period, after the required sample size for questionnaire validation has been reached.
Plan to share: No — Individual participant data will not be shared. Only fully anonymized data will be used for analysis and reported in aggregate form, in compliance with applicable data protection legislation
Started Oct 2025 (actual). Primary completion is estimated for Sep 2026, 11 months after the start.
Of 219 non-industry interventional studies with no phase under Delirium, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 45. This study's planned 11 months is below that.
Counting every sponsor, half of 222 studies reached it within 26 months; a quarter within 12 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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