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NCT Number: NCT07759310

ICU Delirium Playbook Training Study for ICU Nurses

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pisa University Hospital

Pisa, PI, 56121, Italy

Location status: Recruiting

Location contact

Nicola Pagnucci, RN, MSN, PhD

CONTACT

[email protected]

+393472483475 ext. 0039

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICU Delirium PlayBook educational program

Behavioral

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.

Primary outcomes

  1. Knowledge acquisition related to Delirium managment

    Time frame: Pre-intervention (T0), Immediately post-intervention (T1), and at 6 months (T2)

    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.

Secondary outcomes

  1. Evaluation of participants' satisfaction

    Time frame: Immediately post intervention

    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.

  2. To assess the application of the acquired knowledge in clinical practice

    Time frame: Pre-intervention (T0), Immediately post-intervention (T1), and at 6 months (T2)

    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.

  3. To evaluate patient outcomes in terms of increased delirium recognition by ICU nurses

    Time frame: Pre-intervention (T0) and post-intervention (T1) until the target sample size is achieved.

    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).

  4. Questionnaire Validation

    Time frame: During the study period, after the required sample size for questionnaire validation has been reached.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Nicola Pagnucci, RN, MSN, PhD

CONTACT

[email protected]

+393472483475 ext. 0039

Sponsors and collaborators

Lead sponsor

Nicola Pagnucci

Other

Registry information

Official study title

Evaluation of the Effectiveness of the ICU Delirium Playbook in Nursing Education: A Pre-Post Study in the ICUs of the Pisa University Hospital

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 12, 2026
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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