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Comparison of Delirium Evaluation Tools Effectiveness in Intensive Care Patients

  • Clinicaltrials.gov identifier

    NCT03934645

  • Recruitment Status

    Completed

  • First Posted

    May 2, 2019

  • Last update posted

    March 11, 2020

Study Description

Brief summary:

This study compares the efficacy of scoring models used in delirium prediction in patients applying to intensive care unit. The diagnosis of delirium is based on the Intensive Care Delirium Screening Checklist (ICDSC). The aim of this study is determine the sensitivity and specificity of three prediction models (Delirium prediction model for ICU patients version 1 [Predeliric version-1], Delirium prediction model for ICU patients version 2 [Predeliric version-2] and Early prediction model for delirium in ICU patients [E-Predeliric]).

  • Condition or Disease:Delirium
  • Intervention/Treatment: Other: Delirium prediction model for ICU patients, version 1
    Other: Delirium prediction model for ICU patients, version 2
    Other: Early prediction model for delirium in ICU patients
  • Phase: N/A

Detailed Description

Most patients in the intensive care unit (ICU) are entered delirium during hospitalization. Delirium; has been reported that it is associated with significant side effects such as prolonged stay in hospital and intensive care unit, increased morbidity and mortality and high costs. For evaluating delirium in intensive care units; There are several assessment tools such as the Intensive Care Delirium Screening Checklist(ICDSC) etc. The ICDSC checklist is an eight-item screening tool that is based on DSM criteria and applied with data that can be collected through medical records. Its validity has been confirmed by several studies. Assessment tools such as ICDSC; can diagnose after patient is entered the delirium and therefore cannot provide early treatment and preventive measures. Prevention of delirium is more important than the correct treatment of delirium. For preventing delirium; early diagnosis and treatment are necessary. Pre-deliric (DELIRIUM PREDICTION MODEL FOR INTENSIVE CARE PATIENTS) and E-pre-deliric (EARLY PREDICTION MODEL FOR DELIRIUM IN ICU PATIENTS) prediction models; are developed and approved for delirium estimation in intensive care unit patients. Data of the patient in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is found by the pre-deliric model. In the e-pre-deliric model, delirium prediction score is determined by inputting the data of the patient in admission to the intensive care unit. In this study; the definition of delirium was done by ICDSC scoring. Patients with an ICDSC score of 4 and over were diagnosed with delirium. The aim of this study; To determine the sensitivity and specificity of E-pre-deliric and Pre-deliric scores by comparing the effectiveness of ICDSC, E-pre-deliric, Pre-deliric version-1 and Pre-deliric version-2 assessment tools in the prediction of delirium.

Study Design

  • Study Type: Observational
  • Actual Enrollment: 250 participants
  • Observational Model: Other
  • Time Perspective: Prospective
  • Official Title: Comparison of Efficacy of "Pre-deliric Version 1-2, E-predeliric Score and ICDSC" Tests Used in the Diagnosis of Delirium in Intensive Care Patients
  • Actual Study Start Date: November 2017
  • Actual Primary Completion Date: June 2019
  • Actual Study Completion Date: November 2019

Groups and Cohorts

Groups/Cohorts Intervention/treatment
: In Delirium
Intensive Care Delirium Screening Checklist(ICDSC)≥4
Other: Delirium prediction model for ICU patients, version 1
The pre-deliric model version 1 for intensive care patients consists of ten risk factors that are readily available within 24 hours after intensive care admission and has a high predictive value. The model allows for early prediction of delirium and initiation of preventive measures. Data of the patient in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is found.

Other: Delirium prediction model for ICU patients, version 2
The pre-deliric model version 2 for intensive care patients consists of ten risk factors that are readily available within 24 hours after intensive care admission. Data of the patient in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is found. The model allows for early prediction of delirium and initiation of preventive measures.

Other: Early prediction model for delirium in ICU patients
The e-pre-deliric model enables the clinician to identify those patients likely to develop delirium following ICU admission using only nine predictors. In the e-pre-deliric model, delirium prediction score is determined by inputting the data of the patient in admission to the intensive care unit.
: Not In Delirium
Intensive Care Delirium Screening Checklist(ICDSC)=0
Other: Delirium prediction model for ICU patients, version 1
The pre-deliric model version 1 for intensive care patients consists of ten risk factors that are readily available within 24 hours after intensive care admission and has a high predictive value. The model allows for early prediction of delirium and initiation of preventive measures. Data of the patient in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is found.

Other: Delirium prediction model for ICU patients, version 2
The pre-deliric model version 2 for intensive care patients consists of ten risk factors that are readily available within 24 hours after intensive care admission. Data of the patient in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is found. The model allows for early prediction of delirium and initiation of preventive measures.

Other: Early prediction model for delirium in ICU patients
The e-pre-deliric model enables the clinician to identify those patients likely to develop delirium following ICU admission using only nine predictors. In the e-pre-deliric model, delirium prediction score is determined by inputting the data of the patient in admission to the intensive care unit.

Outcome Measures

  • Primary Outcome Measures: 1. Rate of Predeliric version-1 model [ Time Frame: 1 day in admission (1 time) ]
    Data of the patient (ten risk factors) in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is calculated. Each item is scored 0-100.
  • 2. Rate of Predeliric version-2 model [ Time Frame: 1 day in admission (1 time) ]
    Data of the patient (ten risk factors) in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is calculated. Each item is scored 0-100.
  • 3. Rate of E-predeliric model [ Time Frame: 1 day in admission (1 time) ]
    In the e-pre-deliric model, delirium prediction score is calculated by inputting the data of the patient (nine predictors) in admission to the intensive care unit. Each item is scored 0-100.
  • Secondary Outcome Measures: 1. ICDSC score [ Time Frame: 1 time per day during hospitalization ]
    The items include the assessment of: (1) consciousness ( deep sedation/coma, agitation, normal wakefulness, or light sedation); (2) inattention; (3) disorientation; (4) hallucination, delusion, or psychosis; (5) psychomotor agitation or retardation; (6) inappropriate speech or mood; (7) sleep-wake cycle disturbances; and (8) fluctuation of symptomatology. The maximum score is eight; scores of ≥4 indicate the presence of delirium and score zero is indicate not in delirium. Each item is scored 0-8.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: In our study, 250 patients hospitalized more than twenty-four hours in the anesthesia intensive care unit of Trakya University Medical Faculty between 01 November 2017 and 01 November 2019 were accepted.

Criteria

Inclusion Criteria:

- Patients hospitalized in the intensive care unit for more than 24 hours

- Patients 18 years and older

- Patients without mental disability

- Non-pregnant patients

Exclusion Criteria:

- Patients hospitalized in the intensive care unit for less than 24 hours

- Patients under 18 years

- Patients in coma during hospitalization in the intensive care unit

- Patients with aphasia disease, who cannot communicate

- If the compliance rate of the delirium screening was <%80 during a patient's stay in the ICU - If signs of delirium are seen within 24 hours of ICU admission

Contacts and Locations

Contacts

Locations

Turkey, Centrum
Trakya University
Edirne

Sponsors and Collaborators

Trakya University

Investigators

Principal Investigator: DİLEK MEMİŞ, Proffesor Trakya University

More Information

  • Responsible Party: Trakya University
  • ClinicalTrials.gov Identifier: NCT03934645 History of Changes
  • Other Study ID Numbers: TÜTF-BAEK 2017/263
  • First Posted: May 2, 2019 Key Record Dates
  • Last Update Posted: March 11, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Trakya University: Delirium prediction model for ICU patients version 2
    Intensive Care Delirium Screening Checklist (ICDSC)
    Delirium prediction model for ICU patients version 1
    sensitivity
    specificity
    delirium
    intensive care unit (ICU)
    Early prediction model for delirium in ICU patients
  • Additional relevant MeSH terms: Delirium