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

Validation of Brief Delirium Assessments in Non Critically Ill Hospitalized Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Delirium

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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232-4700
      • Vanderbilt Emergency Medicine
    • Nashville, Tennessee, United States, 27232
      • Vanderbilt University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 100 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group 1 - Non-Delirius Patients
Group 2 - Delirious Patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
B-CAM sensitivity and specificity compared with the psychiatrist reference assessment.	day of enrollment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: July 12, 2010
• First Submitted That Met QC Criteria: July 13, 2010
• First Posted (Estimate): July 14, 2010

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Delirium, diagnosis, elderly, hospitalization
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 100859