Nursing EducationNCT07759310
ICU Delirium Playbook Training Study for ICU Nurses
A study testing ICU Delirium PlayBook educational program in people with Nursing Education and Delirium Confusional State, run by Nicola Pagnucci at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nursing Education, Delirium Confusional State, ICU
- What is being tested?
- ICU Delirium PlayBook educational program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2025to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- nurses working in the ICU of the Pisa University Hospital (AOUP).
- nurses with at least 12 months of professional experience in intensive care.
Who cannot join
- -Nurses who do not provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Pisa University Hospital
Pisa, PI, 56121
Nicola Pagnucci, RN, MSN, PhD, +393472483475 ext. 0039, nicola.pagnucci@unipi.it
About this study
Official 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
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.
Read more
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.
- Conditions
- Nursing Education, Delirium Confusional State, ICU
- Being tested
- ICU Delirium PlayBook educational program
- Keywords
- Delirium, Intensive Care Unit, Nursing Education, CAM-ICU
- Medical subject headings
- Confusion, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU Delirium PlayBook educational programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ICU Delirium PlayBook educational program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-intervention (T0), Immediately post-intervention (T1), and at 6 months (T2)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: During the study period, after the required sample size for questionnaire validation has been reached.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Oct 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Nursing EducationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicola Pagnucci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nicola Pagnucci, University of Pisa
- Investigators
- Nicola Pagnucci, RN, MSN, PhD, Study director, University of Pisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07759310
- Sponsor's protocol ID
- ICU_Delirium_PlayBook@IT_2026
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Publications
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/
PubMed 31971702Makhija 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.
PubMed 37457918Kamdar 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.
PubMed 36726713
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07759310
- Acronym / sponsor ID
- ICU_Delirium_PlayBook@IT_2026
- Conditions
- Nursing Education, Delirium Confusional State, ICU
- Keywords
- Delirium, Intensive Care Unit, Nursing Education, CAM-ICU
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Nicola PagnucciUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| ICU Delirium PlayBook Nurse Training Group | Other | Behavioral: ICU Delirium PlayBook educational programICU 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- nurses working in the ICU of the Pisa University Hospital (AOUP).
- nurses with at least 12 months of professional experience in intensive care.
Key exclusion criteria (1 listed)
- -Nurses who do not provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICU Delirium PlayBook educational programThis 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. | Behavioural | ICU Delirium PlayBook Nurse Training Group |
Primary outcome
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.
4 secondary outcomes
Evaluation of participants' satisfaction
Time frame: Immediately post intervention
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)
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.
Questionnaire Validation
Time frame: During the study period, after the required sample size for questionnaire validation has been reached.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Background: PubMed 31971702Delirium: 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/
- Background: PubMed 37457918Makhija 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.
- Background: PubMed 36726713Kamdar 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.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicola Pagnucci, RN, MSN, PhD study director
University of Pisa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICU Delirium PlayBook educational program in people with Nursing Education and Delirium Confusional State, run by Nicola Pagnucci at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola Pagnucci, RN, MSN, PhD (+393472483475 ext. 0039, nicola.pagnucci@unipi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge acquisition related to Delirium managment (time frame: Pre-intervention (T0), Immediately post-intervention (T1), and at 6 months (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07759310, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.