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

• ClinicalTrials.gov Identifier: NCT01162369
• Recruitment Status: Withdrawn
• First Posted: July 14, 2010
• Last Update Posted: May 7, 2018
• Sponsor: Vanderbilt University Medical Center
• Information provided by (Responsible Party): Jin H. Han, Vanderbilt University

Study Description

Brief 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.

Condition or disease
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 Design

• Study Type: Observational
• Actual Enrollment: 0 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Validation of Brief Delirium Assessments in Non Critically Ill Hospitalized Patients
• Study Start Date: July 2013
• Actual Primary Completion Date: July 2015
• Actual Study Completion Date: July 2016

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. B-CAM sensitivity and specificity compared with the psychiatrist reference assessment. [ Time Frame: day of enrollment ]

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 100 Years (Older Adult)
• 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

Locations

United States, Tennessee

Vanderbilt University Hospital

Nashville, Tennessee, United States, 27232

Vanderbilt Emergency Medicine

Nashville, Tennessee, United States, 37232-4700

Sponsors and Collaborators

Vanderbilt University Medical Center

Investigators

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

More Information

• Responsible Party: Jin H. Han, MD, MSc, Vanderbilt University
• ClinicalTrials.gov Identifier: NCT01162369
• Other Study ID Numbers: 100859
• First Posted: July 14, 2010
• Last Update Posted: May 7, 2018
• Last Verified: May 2018

Keywords provided by Jin H. Han, Vanderbilt University:

Delirium, diagnosis, elderly, hospitalization

Additional relevant MeSH terms:

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders