Clinical trial NCT06279390: PRE-DELIRIC Prediction Model Plus SMART Care to Reduce the Incidence of Delirium in ICU Patients
Official title: Effectiveness of PRE-DELIRIC-Guided SMART/SmART Care in Reducing Delirium Incidence Among Surgical Intensive Care Unit Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Unit Delirium
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 381
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: the incidence of delirium
timeFrame: duration of ICU stay (postoperative 30 days)
Secondary outcomes:
measure: duration of ventilator use
timeFrame: duration of ICU stay( (postoperative 30 days)
measure: rate of unplanned self-extubation
timeFrame: duration of intubation( (postoperative 30 days)
measure: day of physical restraint
timeFrame: duration of ICU stay (postoperative 30 days)
measure: level of mobility
timeFrame: duration of ICU stay (postoperative 30 days)
measure: cumulative dose of sedatives
timeFrame: duration of ICU stay (postoperative 30 days)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Wei Ling Hsiao, Master
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan University Hospital
name: Man-Ling Wang, Doctor
role: STUDY_DIRECTOR
References: