このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。英語版ソーステキスト用。

Delirium in the Emergency Department: Novel Screening

2018年5月1日更新者：Jin H. Han、Vanderbilt University Medical Center

Delirium is an acute confusional state characterized by altered or fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. This form of organ dysfunction occurs in up to 10% of older emergency department (ED) 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 emergency physicians because it is not routinely screened for. In an effort to facilitate delirium screening, the investigators sought to validate three brief delirium assessments in the ED setting.

調査の概要

状態

完了

条件

せん妄

詳細な説明

Delirium is often missed because emergency 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. Recently, the investigators 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. The investigators also developed the Emergency Department Delirium Triage Screen (ED-DTS) designed to be highly sensitive and moderately specific delirium assessment for the nurse's triage assessment. It is hypothesized that a negative ED-DTS would rule out delirium, while a positive ED-DTS would require a more formal delirium assessment such as the CAM-ICU and B-CAM. These new delirium assessments require validation in older ED patients. As result, the investigators propose the following and the following specific aims:

Aim #1: To validate the B-CAM in older ED patients. The B-CAM will be performed by a clinical trials associate (CTA) and principal investigator in 200 ED 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 older ED patients. The CAM-ICU will be performed by a clinical trials associate (CTA) and principal investigator in approximately 200 ED 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 #3: To validate the ED-DTS in older ED patients. The ED-DTS will be performed by a clinical trials associate (CTA) and principal investigator in 200 ED 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.

研究の種類

観察的

入学 (実際)

498

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

アメリカ
- Tennessee
  - Nashville、Tennessee、アメリカ、37232
    - Vanderbilt University Medical Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

The participants will be those who are Vanderbilt University Emergency Department patients 65 years or older. There will be no selection bias in regards to race or gender. Only those who meet the inclusion/exclusion criteria will be considered for study inclusion.

説明

Inclusion Criteria:

65 years of age or greater
In the Emergency Department for less than 12 hour at the time of enrollment

Exclusion Criteria:

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
Older Emergency Department Patients Patients who were 65 years or older from the emergency department were enrolled.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Delirium 時間枠：Within 3 hours of the study assessments.	Delirium was diagnosed by a consultation-liaison psychiatrist assessment using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The psychiatrists performed a battery of bedside cognitive tests, including (but not limited to) Clock Drawing Test, Luria hand sequencing task, and tests for verbal fluency. A focused neurological examination (i.e., screening for paraphasic errors, tremors, tone, asterixis, frontal release signs etc.,) and evaluation for affective lability, hallucinations, and level of alertness were also conducted routinely. Confrontational naming, proverb interpretation or similarities, and assessments for apraxias were performed at the discretion of the reference psychiatrists, especially if the diagnosis of delirium was inconclusive.	Within 3 hours of the study assessments.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Vanderbilt University Medical Center

捜査官

主任研究者：Jin H Han, MD, MSc、Vanderbilt University Medical Center

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2009年7月1日

一次修了 (実際)

2012年2月1日

研究の完了 (実際)

2012年2月1日

試験登録日

最初に提出

2010年7月12日

QC基準を満たした最初の提出物

2010年7月13日

最初の投稿 (見積もり)

2010年7月14日

学習記録の更新

投稿された最後の更新 (実際)

2018年5月3日

QC基準を満たした最後の更新が送信されました

2018年5月1日

最終確認日