Delirium in the Emergency Department: Novel Screening

• 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: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Jin H. Han, Vanderbilt University Medical Center

Study Description

Brief Summary:

Delirium is an acute confusional state characterized by altered or fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. This form of organ dysfunction occurs in up to 10% of older emergency department (ED) patients and is associated with worsening mortality, prolonged hospital length of stay, higher health care costs, and accelerated functional and cognitive decline. Despite the negative consequences of delirium, the majority of cases are unrecognized by emergency physicians because it is not routinely screened for. In an effort to facilitate delirium screening, the investigators sought to validate three brief delirium assessments in the ED setting.

Condition or disease
Delirium

Detailed Description:

Delirium is often missed because emergency physicians do not routinely screen for this diagnosis. Most delirium assessments can take up to 10 minutes to perform making them less likely to be incorporated into the routine physician assessment. Using brief (<2 minutes) and easy to use delirium assessments may ameliorate this quality of care issue. The Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) possesses these characteristics, but has only been validated in mechanically and non-mechanically ventilated intensive care unit patients. Recently, the investigators also developed the Brief Confusion Assessment Method (B-CAM) which is a modification of the CAM-ICU. The benefit is that it takes even less time than the CAM-ICU. The investigators also developed the Emergency Department Delirium Triage Screen (ED-DTS) designed to be highly sensitive and moderately specific delirium assessment for the nurse's triage assessment. It is hypothesized that a negative ED-DTS would rule out delirium, while a positive ED-DTS would require a more formal delirium assessment such as the CAM-ICU and B-CAM. These new delirium assessments require validation in older ED patients. As result, the investigators propose the following and the following specific aims:

Aim #1: To validate the B-CAM in older ED patients. The B-CAM will be performed by a clinical trials associate (CTA) and principal investigator in 200 ED patients that are > 65 years old. This instrument will be validated against a psychiatrist's Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition Text Revision assessment as the reference standard.

Aim #2: To validate the CAM-ICU in older ED patients. The CAM-ICU will be performed by a clinical trials associate (CTA) and principal investigator in approximately 200 ED patients that are > 65 years old. This instrument will be validated against a psychiatrist's Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition Text Revision assessment as the reference standard.

Aim #3: To validate the ED-DTS in older ED patients. The ED-DTS will be performed by a clinical trials associate (CTA) and principal investigator in 200 ED patients that are > 65 years old. This instrument will be validated against a psychiatrist's Diagnostic and Statistical Manual of Mental Disorders, 4th. Edition Text Revision assessment as the reference standard.

Study Design

• Study Type: Observational
• Actual Enrollment: 498 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Delirium in the Emergency Department: Novel Screening
• Study Start Date: July 2009
• Actual Primary Completion Date: February 2012
• Actual Study Completion Date: February 2012

Groups and Cohorts

Group/Cohort
Older Emergency Department Patients; Patients who were 65 years or older from the emergency department were enrolled.

Outcome Measures

Primary Outcome Measures :

1. Delirium [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 65 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

The participants will be those who are Vanderbilt University Emergency Department patients 65 years or older. There will be no selection bias in regards to race or gender. Only those who meet the inclusion/exclusion criteria will be considered for study inclusion.

Criteria

Inclusion Criteria:

• 65 years of age or greater
• In the Emergency Department for less than 12 hour at the time of enrollment

Exclusion Criteria:

• Severe mental retardation or dementia
• Baseline communication barriers such as aphasia, deafness, blindness, or who are unable to speak English
• Refusal of consent
• Previous enrollment
• Comatose
• Out of the hospital before the assessments are completed

Contacts and Locations

Locations

United States, Tennessee

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

• Principal Investigator: Jin H Han, MD, MSc; Vanderbilt University Medical Center

More Information

• Responsible Party: Jin H. Han, MD, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT01162343
• Other Study ID Numbers: 081408
• First Posted: July 14, 2010
• Results First Posted: May 3, 2018
• Last Update Posted: May 3, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Keywords provided by Jin H. Han, Vanderbilt University Medical Center:

Delirium, diagnosis, elderly, hospitalization

Additional relevant MeSH terms:

Delirium; Emergencies; Disease Attributes; Pathologic Processes; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders