NCT07759310

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Oct 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Oct 2025Nov 2026

Study Start

First participant enrolled

October 1, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

11 months

First QC Date

July 27, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

DeliriumIntensive Care UnitNursing EducationCAM-ICU

Outcome Measures

Primary Outcomes (1)

  • 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.

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

Secondary Outcomes (4)

  • Evaluation of participants' satisfaction

    Immediately post intervention

  • To assess the application of the acquired knowledge in clinical practice

    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

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

  • Questionnaire Validation

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

Study Arms (1)

ICU Delirium PlayBook Nurse Training Group

OTHER

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

Interventions

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.

ICU Delirium PlayBook Nurse Training Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nurses working in the ICU of the Pisa University Hospital (AOUP).
  • nurses with at least 12 months of professional experience in intensive care.

You may not qualify if:

  • Nurses who do not provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pisa University Hospital

Pisa, PI, 56121, Italy

RECRUITING

Related Publications (3)

  • Delirium: prevention, diagnosis and management in hospital and long-term care. London: National Institute for Health and Care Excellence (NICE); 2023 Jan 18. Available from http://www.ncbi.nlm.nih.gov/books/NBK553009/

    PMID: 31971702BACKGROUND
  • Makhija H, Fine JM, Pollack D, Novelli F, Davidson JE, Cotton SA, Diaz De Leon B, Reyes PA, Montoya JL, Arroyo-Novoa CM, Figueroa-Ramos MI, Song Y, Fuentes AL, LaBuzetta JN, Moore AA, Ely EW, Malhotra A, Needham DM, Martin JL, Kamdar BB. Development and Validation of an ICU Delirium Playbook for Provider Education. Crit Care Explor. 2023 Jul 13;5(7):e0939. doi: 10.1097/CCE.0000000000000939. eCollection 2023 Jul.

    PMID: 37457918BACKGROUND
  • Kamdar BB, Makhija H, Cotton SA, Fine J, Pollack D, Reyes PA, Novelli F, Malhotra A, Needham DM, Martin JL. Development and Evaluation of an Intensive Care Unit Video Series to Educate Staff on Delirium Detection. ATS Sch. 2022 Sep 23;3(4):535-547. doi: 10.34197/ats-scholar.2022-0011OC. eCollection 2022 Dec.

    PMID: 36726713BACKGROUND

MeSH Terms

Conditions

ConfusionDelirium

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Nicola Pagnucci, RN, MSN, PhD

    University of Pisa

    STUDY DIRECTOR

Central Study Contacts

Nicola Pagnucci, RN, MSN, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SEQUENTIAL
Model Details: This is a single-center, quasi-experimental pre-post interventional study. The study evaluates the impact of an educational intervention (ICU Delirium PlayBook) delivered to intensive care unit nurses. Outcomes are assessed before and after the intervention to measure changes in nurses' knowledge, attitudes, and clinical behaviors related to delirium management, as well as selected patient outcomes including delirium detection rates
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Senior Researcher

Study Record Dates

First Submitted

July 27, 2026

First Posted

August 12, 2026

Study Start

October 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

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

Locations