Delirium in the Emergency Department and Its Extension Into Hospitalization (DELINEATE)
|ClinicalTrials.gov Identifier: NCT01651897|
Recruitment Status : Completed
First Posted : July 27, 2012
Last Update Posted : February 28, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||228 participants|
|Actual Study Start Date :||March 1, 2012|
|Actual Primary Completion Date :||November 30, 2014|
|Actual Study Completion Date :||April 30, 2015|
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.
- 6-month mortality and functional status. [ Time Frame: 6-months ]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. ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01651897
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|