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Delirium in the Emergency Department: Novel Screening

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ClinicalTrials.gov Identifier: NCT01162343
Recruitment Status : Completed
First Posted : July 14, 2010
Results First Posted : May 3, 2018
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
Jin H. Han, Vanderbilt University Medical Center

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Delirium
Enrollment 498
Recruitment Details While 498 patients were enrolled, 92 were excluded from the final analysis because they did not receive a psychiatrist reference standard delirium assessment. As a result, 406 patients were included for the final analysis.
Pre-assignment Details  
Arm/Group Title Older Emergency Department Patients
Hide Arm/Group Description Patients who were 65 years or older from the emergency department were enrolled.
Period Title: Overall Study
Started 498
Completed 406
Not Completed 92
Reason Not Completed
Left ED prior to psychiatrist assessment             80
Refused psychiatrist assessment             12
Arm/Group Title Older Emergency Department Patients
Hide Arm/Group Description Patients who were 65 years or older from the emergency department were enrolled.
Overall Number of Baseline Participants 406
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 406 participants
73.5
(69 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants
Female
202
  49.8%
Male
204
  50.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 406 participants
Non-white
57
  14.0%
White
349
  86.0%
Dementia documented in medical record  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants
24
   5.9%
Charlson Comorbidity Index   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Points on a scale
Number Analyzed 406 participants
2
(1 to 4)
[1]
Measure Description: Total range for the Charlson Comorbidity Index is 0 to 33. Higher values represent higher comorbidity burden.
Acute Physiology Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Points on a scale
Number Analyzed 406 participants
2
(1 to 4)
[1]
Measure Description: Measured by APACHE II, a severity-of-disease classification system Higher values represent higher severity of illness (sicker). APACHE II score ranges from 0 to 71
Admitted to the hospital  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 406 participants
294
  72.4%
1.Primary Outcome
Title Delirium
Hide Description Delirium was diagnosed by a consultation-liaison psychiatrist assessment using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The psychiatrists performed a battery of bedside cognitive tests, including (but not limited to) Clock Drawing Test, Luria hand sequencing task, and tests for verbal fluency. A focused neurological examination (i.e., screening for paraphasic errors, tremors, tone, asterixis, frontal release signs etc.,) and evaluation for affective lability, hallucinations, and level of alertness were also conducted routinely. Confrontational naming, proverb interpretation or similarities, and assessments for apraxias were performed at the discretion of the reference psychiatrists, especially if the diagnosis of delirium was inconclusive.
Time Frame Within 3 hours of the study assessments.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Older Emergency Department Patients
Hide Arm/Group Description:
Patients who were 65 years or older from the emergency department were enrolled.
Overall Number of Participants Analyzed 406
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percent
Research Assistant DTS Sensitivity
98.0
(89.5 to 99.5)
Research Assistant DTS Specificity
56.2
(51.0 to 61.3)
Physician DTS Sensitivity
56.2
(51.0 to 61.3)
Physician DTS Specificity
54.8
(49.6 to 59.9)
Research Assistant bCAM Sensitivity
78.0
(64.8 to 87.2)
Research Assistant bCAM Specificity
96.9
(94.6 to 98.3)
Physician bCAM Sensitivity
84.0
(71.5 to 91.7)
Physician bCAM Specificity
95.8
(93.2 to 97.4)
Research Assistant CAM-ICU Sensitivity
68.0
(54.2 to 79.2)
Research Assistant CAM-ICU Specificity
98.6
(96.8 to 99.4)
Physician CAM-ICU Sensitivity
72.0
(58.3 to 82.5)
Physician CAM-ICU Specificity
98.6
(96.8 to 99.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Older Emergency Department Patients
Hide Arm/Group Description Patients who were 65 years or older from the emergency department were enrolled.
All-Cause Mortality
Older Emergency Department Patients
Affected / at Risk (%)
Total   0/498 (0.00%) 
Hide Serious Adverse Events
Older Emergency Department Patients
Affected / at Risk (%)
Total   0/498 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Older Emergency Department Patients
Affected / at Risk (%)
Total   0/498 (0.00%) 
This was a single center study and should be externally validated. Our findings cannot be generalized to those who are younger than 65 years old.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jin Han, MD
Organization: Vanderbilt University Medical Center
Phone: 615-936-0253
EMail: jin.h.han@vanderbilt.edu
Layout table for additonal information
Responsible Party: Jin H. Han, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT01162343    
Other Study ID Numbers: 081408
First Submitted: July 12, 2010
First Posted: July 14, 2010
Results First Submitted: February 25, 2017
Results First Posted: May 3, 2018
Last Update Posted: May 3, 2018