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出境医 / 临床实验 / Comparison of Delirium Evaluation Tools Effectiveness in Intensive Care Patients

Comparison of Delirium Evaluation Tools Effectiveness in Intensive Care Patients

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 Intervention/treatment
Delirium 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

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
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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 1, 2017
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : November 1, 2019
Arms and Interventions
Group/Cohort Intervention/treatment
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 Name: Pre-deliric version-1

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 Name: Pre-deliric version-2

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.
Other Name: E-pre-deliric

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 Name: Pre-deliric version-1

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 Name: Pre-deliric version-2

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.
Other Name: E-pre-deliric

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
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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

Locations
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Turkey
Trakya University
Edirne, Centrum, Turkey, 22030
Sponsors and Collaborators
Trakya University
Investigators
Layout table for investigator information
Principal Investigator: DİLEK MEMİŞ, Proffesor Trakya University
Tracking Information
First Submitted Date April 19, 2019
First Posted Date May 2, 2019
Last Update Posted Date March 11, 2020
Actual Study Start Date November 1, 2017
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 30, 2019)
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 30, 2019)
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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparison of Delirium Evaluation Tools Effectiveness in Intensive Care Patients
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
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]).
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 Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Delirium
Intervention
  • 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 Name: Pre-deliric version-1
  • 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 Name: Pre-deliric version-2
  • 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.
    Other Name: E-pre-deliric
Study Groups/Cohorts
  • Not In Delirium
    Intensive Care Delirium Screening Checklist(ICDSC)=0
    Interventions:
    • 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
  • In Delirium
    Intensive Care Delirium Screening Checklist(ICDSC)≥4
    Interventions:
    • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 30, 2019)
250
Original Estimated Enrollment Same as current
Actual Study Completion Date November 1, 2019
Actual Primary Completion Date June 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03934645
Other Study ID Numbers TÜTF-BAEK 2017/263
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Onur Kucuk, Trakya University
Study Sponsor Trakya University
Collaborators Not Provided
Investigators
Principal Investigator: DİLEK MEMİŞ, Proffesor Trakya University
PRS Account Trakya University
Verification Date March 2020

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