Delirium in the Emergency Department and Its Extension Into Hospitalization

NCT01651897 | Completed

• 1 other identifier: 111580
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

Delirium occurs in 10% of older emergency department (ED) patients, yet it remains poorly understood. To date, the predominance of delirium studies have been conducted in hospitalized patients and therefore have limited generalizability to the ED. Understanding ED delirium's natural course and its effect on outcomes is not well characterized. The investigators hypothesize that a significant proportion of patients who are delirious in the ED will remain delirious in the hospital, and persistent cases of ED delirium will be significantly associated with higher 6-month mortality and accelerated functional decline. To test this hypothesis, the investigators will perform a prospective cohort study that will enroll 150 older ED patients with delirium and a random selection of 150 older ED patients without delirium; both groups will comprise of admitted ED patients only. Once enrolled in the ED, the investigators will assess patients for 7 days during hospitalization and perform phone follow-up at 6-months.

Conditions

Delirium

Keywords

delirium; emergency department; natural course; outcomes; elderly

Outcome Measures

Primary Outcomes (2)

• 6-month mortality and functional status.

  We will perform 6-month phone follow-up to ascertain death and functional status.

  6-months

• Emergency department delirium duration

  Patients will be enrolled in the emergency department and will be assessed for delirium daily until hospital day #7 or hospital discharge.

  Until hospital discharge or the first 7-days of hospitalization.

Study Arms (2)

Delirious in the ED

Patients who were delirious in the ED at either the 0-hour or 3-hour delirium assessment.

Non-Delirious in the ED

Patients who were non-delirious in the ED at both the 0-hour or 3-hour delirium assessment.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll 150 delirious ED patients and a random selection of 150 non-delirious ED patients who are hospitalized and reassess their delirium status daily throughout their hospitalization.

You may qualify if:

• Years and older
• In an ED bed for less than 4 hours at the time of enrollment
• Any possibility of being admitted to the hospital

You may not qualify if:

• Refuse consent
• Have been previously enrolled
• Unarousable to verbal stimuli
• Have severe mental retardation or severe dementia characterized by being non-verbal or unable to comprehend simple instructions at baseline
• Deaf
• Patient or surrogate is non-English speaking
• Discharged from the emergency department

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

15-30 cc of blood

MeSH Terms

Conditions

Delirium; Emergencies

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc

Study Record Dates

• First Submitted: July 25, 2012
• First Posted: July 27, 2012
• Study Start: March 1, 2012
• Primary Completion: November 30, 2014
• Study Completion: April 30, 2015
• Last Updated: February 28, 2017

Record last verified: 2017-02

Locations

US (1)