Brief Delirium Assessments in Non-Intensive Care Unit (ICU) Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified August 2011 by Vanderbilt University.
Recruitment status was: Recruiting

Sponsor:

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT01162369

First received: July 12, 2010

Last updated: August 1, 2011

Last verified: August 2011

History of Changes

Purpose

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.

Condition
Delirium


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Validation of Brief Delirium Assessments in Non Critically Ill Hospitalized Patients

Resource links provided by NLM:

MedlinePlus related topics: Delirium

U.S. FDA Resources

Further study details as provided by Vanderbilt University:


Estimated Enrollment:	150
Study Start Date:	August 2010
Estimated Study Completion Date:	August 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts
Group 1 - Non-Delirius Patients
Group 2 - Delirious Patients

Detailed 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.

Eligibility


Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

The participants will be those who are Vanderbilt University Hospital inpatients aged 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.

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162369

Contacts


Contact: Jin H Han, MD, MSc	615-936-0087	jin.h.han@vanderbilt.com
Contact: Karen F Miller, RN, MPA	615-936-4790	karen.miller@vanderbilt.edu

Locations


United States, Tennessee
Vanderbilt University Hospital	Not yet recruiting
Nashville, Tennessee, United States, 27232
Contact: Jin H Han, MD, MSc 615-936-0087 jin.h.han@vanderbilt.edu
Contact: Karen F Miller, RN, MPA 615-936-4790 karen.miller@vanderbilt.edu
Principal Investigator: Jin H Han, MD, MSc
Vanderbilt Emergency Medicine	Recruiting
Nashville, Tennessee, United States, 37232-4700

Sponsors and Collaborators

Vanderbilt University

Investigators


Principal Investigator:	Jin H Han, MD, MSc	Vanderbilt University Medical Center

More Information


Responsible Party:	Jin H. Han, MD, MSc, Vanderbilt University Medical Center - Emergency Medicine
ClinicalTrials.gov Identifier:	NCT01162369 History of Changes
Other Study ID Numbers:	IRB# Pending
Study First Received:	July 12, 2010
Last Updated:	August 1, 2011

Keywords provided by Vanderbilt University:


Delirium, diagnosis, elderly, hospitalization

Additional relevant MeSH terms:


Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations	Nervous System Diseases Signs and Symptoms Neurocognitive Disorders Mental Disorders

ClinicalTrials.gov processed this record on September 21, 2017

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