Delirium
Conditions
Keywords
Delirium, diagnosis, elderly, hospitalization
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.
Detailed description
Delirium is often missed because emergency 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. Recently, the investigators 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. The investigators also developed the Emergency Department Delirium Triage Screen (ED-DTS) designed to be highly sensitive and moderately specific delirium assessment for the nurse's triage assessment. It is hypothesized that a negative ED-DTS would rule out delirium, while a positive ED-DTS would require a more formal delirium assessment such as the CAM-ICU and B-CAM. These new delirium assessments require validation in older ED patients. As result, the investigators propose the following and the following specific aims: Aim #1: To validate the B-CAM in older ED patients. The B-CAM will be performed by a clinical trials associate (CTA) and principal investigator in 200 ED 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 older ED patients. The CAM-ICU will be performed by a clinical trials associate (CTA) and principal investigator in approximately 200 ED 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 #3: To validate the ED-DTS in older ED patients. The ED-DTS will be performed by a clinical trials associate (CTA) and principal investigator in 200 ED 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.
Interventions
None listed
Sponsors
Vanderbilt University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 65 years of age or greater * In the Emergency Department for less than 12 hour at the time of enrollment
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delirium | Within 3 hours of the study assessments. | 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. |
Countries
United States
Participant flow
Recruitment details
While 498 patients were enrolled, 92 were excluded from the final analysis because they did not receive a psychiatrist reference standard delirium assessment. As a result, 406 patients were included for the final analysis.
Participants by arm
| Arm | Count |
|---|---|
| Older Emergency Department Patients Patients who were 65 years or older from the emergency department were enrolled. | 406 |
| Total | 406 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Left ED prior to psychiatrist assessment | 80 |
| Overall Study | Refused psychiatrist assessment | 12 |
Baseline characteristics
| Characteristic | Older Emergency Department Patients |
|---|---|
| Acute Physiology Score | 2 points on a scale |
| Admitted to the hospital | 294 Participants |
| Age, Continuous | 73.5 years |
| Charlson Comorbidity Index | 2 points on a scale |
| Dementia documented in medical record | 24 Participants |
| Race/Ethnicity, Customized Race Non-white | 57 Participants |
| Race/Ethnicity, Customized Race White | 349 Participants |
| Sex: Female, Male Female | 202 Participants |
| Sex: Female, Male Male | 204 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 498 |
| other Total, other adverse events | 0 / 498 |
| serious Total, serious adverse events | 0 / 498 |
Outcome results
Primary
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.
Time frame: Within 3 hours of the study assessments.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Older Emergency Department Patients | Delirium | Research Assistant DTS Sensitivity | 98.0 percent |
| Older Emergency Department Patients | Delirium | Research Assistant DTS Specificity | 56.2 percent |
| Older Emergency Department Patients | Delirium | Physician DTS Sensitivity | 56.2 percent |
| Older Emergency Department Patients | Delirium | Physician DTS Specificity | 54.8 percent |
| Older Emergency Department Patients | Delirium | Research Assistant bCAM Sensitivity | 78.0 percent |
| Older Emergency Department Patients | Delirium | Research Assistant bCAM Specificity | 96.9 percent |
| Older Emergency Department Patients | Delirium | Physician bCAM Sensitivity | 84.0 percent |
| Older Emergency Department Patients | Delirium | Physician bCAM Specificity | 95.8 percent |
| Older Emergency Department Patients | Delirium | Research Assistant CAM-ICU Sensitivity | 68.0 percent |
| Older Emergency Department Patients | Delirium | Research Assistant CAM-ICU Specificity | 98.6 percent |
| Older Emergency Department Patients | Delirium | Physician CAM-ICU Sensitivity | 72.0 percent |
| Older Emergency Department Patients | Delirium | Physician CAM-ICU Specificity | 98.6 percent |