Trial Outcomes & Findings for Delirium in the Emergency Department: Novel Screening (NCT NCT01162343)

NCT ID: NCT01162343

Last Updated: 2018-05-03

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 498 participants
• Primary outcome timeframe: Within 3 hours of the study assessments.
• Results posted on: 2018-05-03

Participant Flow

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.

Participant milestones

Measure	Older Emergency Department Patients Patients who were 65 years or older from the emergency department were enrolled.
Overall Study STARTED	498
Overall Study COMPLETED	406
Overall Study NOT COMPLETED	92

Reasons for withdrawal

Measure	Older Emergency Department Patients Patients who were 65 years or older from the emergency department were enrolled.
Overall Study Left ED prior to psychiatrist assessment	80
Overall Study Refused psychiatrist assessment	12

Baseline Characteristics

Delirium in the Emergency Department: Novel Screening

Baseline characteristics by cohort

Measure	Older Emergency Department Patients n=406 Participants Patients who were 65 years or older from the emergency department were enrolled.
Age, Continuous	73.5 years n=5 Participants
Sex: Female, Male Female	202 Participants n=5 Participants
Sex: Female, Male Male	204 Participants n=5 Participants
Race/Ethnicity, Customized Race · Non-white	57 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	349 Participants n=5 Participants
Dementia documented in medical record	24 Participants n=5 Participants
Charlson Comorbidity Index	2 points on a scale n=5 Participants
Acute Physiology Score	2 points on a scale n=5 Participants
Admitted to the hospital	294 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 3 hours of the study assessments.

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.

Outcome measures

Measure	Older Emergency Department Patients n=406 Participants Patients who were 65 years or older from the emergency department were enrolled.
Delirium Research Assistant DTS Sensitivity	98.0 percent Interval 89.5 to 99.5
Delirium Research Assistant DTS Specificity	56.2 percent Interval 51.0 to 61.3
Delirium Physician DTS Sensitivity	56.2 percent Interval 51.0 to 61.3
Delirium Physician DTS Specificity	54.8 percent Interval 49.6 to 59.9
Delirium Research Assistant bCAM Sensitivity	78.0 percent Interval 64.8 to 87.2
Delirium Research Assistant bCAM Specificity	96.9 percent Interval 94.6 to 98.3
Delirium Physician bCAM Sensitivity	84.0 percent Interval 71.5 to 91.7
Delirium Physician bCAM Specificity	95.8 percent Interval 93.2 to 97.4
Delirium Research Assistant CAM-ICU Sensitivity	68.0 percent Interval 54.2 to 79.2
Delirium Research Assistant CAM-ICU Specificity	98.6 percent Interval 96.8 to 99.4
Delirium Physician CAM-ICU Sensitivity	72.0 percent Interval 58.3 to 82.5
Delirium Physician CAM-ICU Specificity	98.6 percent Interval 96.8 to 99.4

Adverse Events

Older Emergency Department Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jin Han, MD

Vanderbilt University Medical Center

Phone: 615-936-0253

Email: jin.h.han@vanderbilt.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place