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

This study is currently recruiting participants.
Verified August 2011 by Vanderbilt University
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
Genders Eligible for Study:   Both
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
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
  More Information

No publications provided

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
Health Authority: United States: Institutional Review Board

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013