NCT01162343

Brief Summary

Delirium is an acute confusional state characterized by altered or fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. This form of organ dysfunction occurs in up to 10% of older emergency department (ED) 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 emergency physicians because it is not routinely screened for. In an effort to facilitate delirium screening, the investigators sought to validate three brief delirium assessments in the ED setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
498

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 14, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

May 3, 2018

Completed
Last Updated

May 3, 2018

Status Verified

May 1, 2018

Enrollment Period

2.6 years

First QC Date

July 12, 2010

Results QC Date

February 25, 2017

Last Update Submit

May 1, 2018

Conditions

Keywords

Delirium, diagnosis, elderly, hospitalization

Outcome Measures

Primary Outcomes (1)

  • Delirium

    Delirium was diagnosed by a consultation-liaison psychiatrist assessment using Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria. The psychiatrists performed a battery of bedside cognitive tests, including (but not limited to) Clock Drawing Test, Luria hand sequencing task, and tests for verbal fluency. A focused neurological examination (i.e., screening for paraphasic errors, tremors, tone, asterixis, frontal release signs etc.,) and evaluation for affective lability, hallucinations, and level of alertness were also conducted routinely. Confrontational naming, proverb interpretation or similarities, and assessments for apraxias were performed at the discretion of the reference psychiatrists, especially if the diagnosis of delirium was inconclusive.

    Within 3 hours of the study assessments.

Study Arms (1)

Older Emergency Department Patients

Patients who were 65 years or older from the emergency department were enrolled.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The participants will be those who are Vanderbilt University Emergency Department patients 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 Emergency Department for less than 12 hour at the time of enrollment

You may not qualify if:

  • Severe mental retardation or dementia
  • Baseline communication barriers such as aphasia, deafness, blindness, or who are unable to speak English
  • Refusal of consent
  • Previous enrollment
  • Comatose
  • Out of the hospital before the assessments are completed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

DeliriumDisease

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPathologic Processes

Limitations and Caveats

This was a single center study and should be externally validated. Our findings cannot be generalized to those who are younger than 65 years old.

Results Point of Contact

Title
Dr. Jin Han, MD
Organization
Vanderbilt University Medical Center

Study Officials

  • Jin H Han, MD, MSc

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 14, 2010

Study Start

July 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

May 3, 2018

Results First Posted

May 3, 2018

Record last verified: 2018-05

Locations