PRE-DELIRIC Prediction Model Plus SMART Care to Reduce the Incidence of Delirium in ICU Patients

Effectiveness of PRE-DELIRIC-Guided SMART/SmART Care in Reducing Delirium Incidence Among Surgical Intensive Care Unit Patients

Delirium is a severe acute brain dysfunction characterised by sudden confusion, inattention and fluctuating level of consciousness, which mainly affects intubated intensive care patients. It increases the risk of self-extubation, prolongs ICU stay and increases mortality. The incidence of delirium in ICUs varies, with approximately 33.3% of patients affected, and rates of new-onset and pre-existing delirium range from 4% to 89%. Accurate diagnosis is challenging, with 60-80% of patients remaining undiagnosed. Early detection is critical for intervention and improved outcomes.

To address these issues, the PREdiction of DELIRium (PRE-DELIRIC) model incorporates 10 risk factors and predicts delirium within 24 hours of ICU admission, allowing risk stratification into low to very high risk categories. It recalibrates predictive values with a sensitivity of 91.3% and specificity of 64.4% using a cut-off score of 27%. However, its integration into delirium management is underexplored. Delirium risk stratification supports efficient resource allocation, cost control, workload reduction and ethical care, while promptly identifying high-risk patients.

In this study, Investigators evaluate the integration of the PRE-DELIRIC model into a comprehensive delirium management approach called PRE-DELIRIC-guided SMART/SmART care. SMART care includes improving familiarity, assessing pain and anxiety, reducing equipment discomfort and cognitive stimulation. Patients with PRE-DELIRIC scores >30% receive SMART care and multidisciplinary involvement, based on the American Delirium Society.

Study Overview

• Status: Completed
• Conditions: Intensive Care Unit Delirium

• Study Type: Observational
• Enrollment (Actual): 381

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The inclusion criteria encompass patients admitted to a surgical ICU in Taipei, Taiwan, from January 2021 to March 2023.

Description

Inclusion Criteria:

1. SICU patients are over 18 years old. 2. received surgery intervention

Exclusion Criteria:

1. Clinical diagnosis of mental disorders
2. Underwent neurosurgical procedures,
3. Discharged from the ICU within 24 hours of admission
4. Transitioned to active life support withdrawal or "comfort care only" within 24 hours of ICU admission

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the incidence of delirium	The incidence of delirium which was assessed by each shift primary ICU nurse by using the ICDSC.	duration of ICU stay (postoperative 30 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of ventilator use	duration of ventilator use	duration of ICU stay( (postoperative 30 days)
rate of unplanned self-extubation	indicates the proportion of patients who unintentionally remove their endotracheal tubes (Yes/No)	duration of intubation( (postoperative 30 days)
day of physical restraint	day of physical restraint	duration of ICU stay (postoperative 30 days)
level of mobility	level 0-10 of mobility	duration of ICU stay (postoperative 30 days)
cumulative dose of sedatives	Sedatives cumulative drugs include midazolam, propofol and dexmedetomidine record 24hours	duration of ICU stay (postoperative 30 days)

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Wei Ling Hsiao, Master, National Taiwan University Hospital; Study Director: Man-Ling Wang, Doctor, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: November 12, 2023
• First Submitted That Met QC Criteria: February 25, 2024
• First Posted (Estimated): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 202305126RINC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No