Study Stopped
Lack of funding.
Brief Delirium Assessments in Non-Intensive Care Unit (ICU) Patients
Validation of Brief Delirium Assessments in Non Critically Ill Hospitalized Patients
1 other identifier
observational
N/A
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2013
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2010
CompletedFirst Posted
Study publicly available on registry
July 14, 2010
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedMay 7, 2018
May 1, 2018
2 years
July 12, 2010
May 1, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
B-CAM sensitivity and specificity compared with the psychiatrist reference assessment.
day of enrollment
Study Arms (2)
Group 1 - Non-Delirius Patients
Group 2 - Delirious Patients
Eligibility Criteria
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.
You may qualify if:
- years of age or greater
- In the non-ICU inpatient setting
- Consulted and evaluated by psychiatry
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Vanderbilt University Hospital
Nashville, Tennessee, 27232, United States
Vanderbilt Emergency Medicine
Nashville, Tennessee, 37232-4700, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin H Han, MD, MSc
Vanderbilt University Medical Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, MSc
Study Record Dates
First Submitted
July 12, 2010
First Posted
July 14, 2010
Study Start
July 1, 2013
Primary Completion
July 1, 2015
Study Completion
July 1, 2016
Last Updated
May 7, 2018
Record last verified: 2018-05