Delirium in the Emergency Department and Its Extension Into Hospitalization (DELINEATE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2012 by Vanderbilt University
Sponsor:
Information provided by (Responsible Party):
Jin H. Han, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT01651897
First received: July 25, 2012
Last updated: July 26, 2012
Last verified: July 2012
  Purpose

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.


Condition
Delirium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 6-month mortality and functional status. [ Time Frame: 6-months ] [ Designated as safety issue: No ]
    We will perform 6-month phone follow-up to ascertain death and functional status.

  • Emergency department delirium duration [ Time Frame: Until hospital discharge or the first 7-days of hospitalization. ] [ Designated as safety issue: No ]
    Patients will be enrolled in the emergency department and will be assessed for delirium daily until hospital day #7 or hospital discharge.


Biospecimen Retention:   Samples Without DNA

15-30 cc of blood


Estimated Enrollment: 250
Study Start Date: February 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Older ED patients with delirium who are admitted
Older ED patients without delirium who are admitted

Detailed Description:

Delirium is an acute confusional state characterized by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. The prevalence of delirium in elderly patients is approximately 10% in emergency department (ED) patients. Several hospital-based studies have shown delirium to be associated with worsening mortality,longer hospital length of stay, higher health care costs,and poorer long-term functional and cognitive function.

However, delirium in the ED remains poorly understood. Specifically, its natural course is not well characterized and represents a critical gap in knowledge. Improving our understanding is paramount for several reasons. If the majority of delirium persists beyond the ED and is associated with long-term adverse outcomes, then routine delirium surveillance in the busy ED environment can be justified. Understanding the natural course may also help physicians identify delirious patients at highest risk for adverse outcomes and would be the focus of future delirium interventions. Lastly, we don't know if all patients with delirium require an admission. Understanding the natural course may help identify delirious patients that can be safely discharged home and those who require a hospital admission.

Given this paucity of data, we are conducting this study with the following specific aims: 1) To describe the frequency in which delirium in the ED persists into hospitalization and determine how patient factors and clinical factors affect delirium persistence. 2) To determine how ED delirium duration affects 6-month outcomes. To achieve these aims, we will perform a prospective cohort study thatwill enroll 125 older ED patients with delirium and a random selection of 125 older ED patients without delirium; both groups will comprise of admitted ED patients only. Once enrolled in the ED, we will assess patients for 7 days during hospitalization and perform phone follow-up at 6-months.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 65 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01651897

Locations
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Jin H Han, MD, MSc    615-936-1434    jin.h.han@vanderbilt.edu   
Principal Investigator: Jin H Han, MD, MSc         
Sponsors and Collaborators
Vanderbilt University
  More Information

No publications provided

Responsible Party: Jin H. Han, MD, MSc, Vanderbilt University
ClinicalTrials.gov Identifier: NCT01651897     History of Changes
Other Study ID Numbers: 111580
Study First Received: July 25, 2012
Last Updated: July 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
delirium
emergency department
natural course
outcomes
elderly

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 26, 2014