Brief Delirium Assessments in Non-Intensive Care Unit (ICU) Patients
Recruitment status was Recruiting
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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 |
| 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 |
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.
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01162369
| 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 |
| United States, Tennessee | |
| Vanderbilt Emergency Medicine | Recruiting |
| Nashville, Tennessee, United States, 37232-4700 | |
| 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 | |
| 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 Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms |
ClinicalTrials.gov processed this record on March 03, 2015