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

NCT06279390 | Completed

• 1 other identifier: 202305126RINC
• Study Type: observational
• Target: 381
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Unit Delirium

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• duration of ventilator use

  duration of ICU stay( (postoperative 30 days)

• rate of unplanned self-extubation

  duration of intubation( (postoperative 30 days)

• day of physical restraint

  duration of ICU stay (postoperative 30 days)

• level of mobility

  duration of ICU stay (postoperative 30 days)

• cumulative dose of sedatives

  duration of ICU stay (postoperative 30 days)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

• Wei Ling Hsiao, Master

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

• Man-Ling Wang, Doctor

  National Taiwan University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2023
• First Posted: February 28, 2024
• Study Start: June 8, 2023
• Primary Completion: October 30, 2023
• Study Completion: October 30, 2023
• Last Updated: February 28, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)