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临床试验/NCT01651897
NCT01651897已完成不适用

Delirium in the Emergency Department and Its Extension Into Hospitalization

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2012年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
228
试验地点
1
主要终点
6-month mortality and functional status.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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
  • Patient or surrogate is non-English speaking
  • Discharged from the emergency department

结局指标

主要结局

6-month mortality and functional status.

时间窗: 6-months

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

Emergency department delirium duration

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin H. Han

MD, MSc

Vanderbilt University

研究点 (1)

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