Brief Delirium Assessments in Non-Intensive Care Unit (ICU) Patients
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ClinicalTrials.gov Identifier: NCT01162369 |
Recruitment Status :
Withdrawn
(Lack of funding.)
First Posted : July 14, 2010
Last Update Posted : May 7, 2018
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Condition or disease |
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Delirium |
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 |
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 |
Group/Cohort |
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Group 1 - Non-Delirius Patients |
Group 2 - Delirious Patients |
- B-CAM sensitivity and specificity compared with the psychiatrist reference assessment. [ Time Frame: day of enrollment ]

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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 |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01162369
United States, Tennessee | |
Vanderbilt University Hospital | |
Nashville, Tennessee, United States, 27232 | |
Vanderbilt Emergency Medicine | |
Nashville, Tennessee, United States, 37232-4700 |
Principal Investigator: | Jin H Han, MD, MSc | Vanderbilt University Medical Center |
Responsible Party: | Jin H. Han, MD, MSc, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT01162369 |
Other Study ID Numbers: |
100859 |
First Posted: | July 14, 2010 Key Record Dates |
Last Update Posted: | May 7, 2018 |
Last Verified: | May 2018 |
Delirium, diagnosis, elderly, hospitalization |
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations |
Nervous System Diseases Neurocognitive Disorders Mental Disorders |