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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01162369
Other study ID # 100859
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date July 2013
Est. completion date July 2016

Study information

Verified date May 2018
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2016
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 65 Years to 100 Years
Eligibility Inclusion Criteria:

- 65 years of age or greater

- In the non-ICU inpatient setting

- Consulted and evaluated by psychiatry

Exclusion Criteria:

- Severe mental retardation or dementia

- Baseline communication barriers such aphasia, deafness, blindness, or who are unable to speak English

- Refusal of consent

- Previous enrollment

- Comatose

- Out of hospital before the assessments are completed

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Vanderbilt Emergency Medicine Nashville Tennessee
United States Vanderbilt University Hospital Nashville Tennessee

Sponsors (1)

Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary B-CAM sensitivity and specificity compared with the psychiatrist reference assessment. day of enrollment
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