跳至主要内容
临床试验/NCT01162369
NCT01162369撤回不适用

Validation of Brief Delirium Assessments in Non Critically Ill Hospitalized Patients

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
B-CAM sensitivity and specificity compared with the psychiatrist reference assessment.

研究概览

简要总结

Delirium is an acute confusional state characterized by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. This form of organ dysfunction occurs in up to 50% of hospitalized 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 hospital physicians because it is not routinely screened for. In an effort to facilitate delirium screening, we sought to validate two brief delirium assessments (<2 minutes) in the hospital setting.

详细描述

Delirium is often missed because 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. As a result, it still requires validation in the non-ICU hospitalized patients. Recently, we 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. However, it also requires validation in hospitalized patients. As result, we propose the following and the following specific aims:

Aim #1: To validate the B-CAM in non-ICU hospitalized patients. The B-CAM will be performed by a clinical trials associate (CTA) and principal investigator in 150 non-ICU hospitalized 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 non-ICU hospitalized patients. The CAM-ICU will be performed by a clinical trials associate (CTA) and principal investigator in approximately 150 non-ICU hospitalized 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.

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 100 Years(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 65 years of age or greater
  • In the non-ICU inpatient setting
  • Consulted and evaluated by psychiatry

排除标准

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

结局指标

主要结局

B-CAM sensitivity and specificity compared with the psychiatrist reference assessment.

时间窗: day of enrollment

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 (2)

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