DeliriumDELINEATENCT01651897
Delirium in the Emergency Department and Its Extension Into Hospitalization
An observational study of Delirium, run by Vanderbilt University at 1 site in United States.
Trial summary
Delirium occurs in 10% of older emergency department (ED) patients, yet it remains poorly understood. To date, the predominance of delirium studies have been conducted in hospitalized patients and therefore have limited generalizability to the ED. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2012to 30 Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: We will enroll 150 delirious ED patients and a random selection of 150 non-delirious ED patients who are hospitalized and reassess their delirium status daily throughout their hospitalization.
Who may be able to join
- 65 Years and older
- In an ED bed for less than 4 hours at the time of enrollment
- Any possibility of being admitted to the hospital
Who cannot join
- Refuse consent
- Have been previously enrolled
- Unarousable to verbal stimuli
- Have severe mental retardation or severe dementia characterized by being non-verbal or unable to comprehend simple instructions at baseline
- Deaf
- Patient or surrogate is non-English speaking
- Discharged from the emergency department
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
Delirium occurs in 10% of older emergency department (ED) patients, yet it remains poorly understood. To date, the predominance of delirium studies have been conducted in hospitalized patients and therefore have limited generalizability to the ED. Understanding ED delirium's natural course and its effect on outcomes is not well characterized. The investigators hypothesize that a significant proportion of patients who are delirious in the ED will remain delirious in the hospital, and persistent cases of ED delirium will be significantly associated with higher 6-month mortality and accelerated functional decline. To test this hypothesis, the investigators will perform a prospective cohort study that will enroll 150 older ED patients with delirium and a random selection of 150 older ED patients without delirium; both groups will comprise of admitted ED patients only. Once enrolled in the ED, the investigators will assess patients for 7 days during hospitalization and perform phone follow-up at 6-months.
Read the detailed description
Delirium is an acute confusional state characterized by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. The prevalence of delirium in elderly patients is approximately 10% in emergency department (ED) patients. Several hospital-based studies have shown delirium to be associated with worsening mortality,longer hospital length of stay, higher health care costs,and poorer long-term functional and cognitive function.
However, delirium in the ED remains poorly understood. Specifically, its natural course is not well characterized and represents a critical gap in knowledge. Improving our understanding is paramount for several reasons. If the majority of delirium persists beyond the ED and is associated with long-term adverse outcomes, then routine delirium surveillance in the busy ED environment can be justified. Understanding the natural course may also help physicians identify delirious patients at highest risk for adverse outcomes and would be the focus of future delirium interventions. Lastly, we don't know if all patients with delirium require an admission. Understanding the natural course may help identify delirious patients that can be safely discharged home and those who require a hospital admission.
Given this paucity of data, we are conducting this study with the following specific aims: 1) To describe the frequency in which delirium in the ED persists into hospitalization and determine how patient factors and clinical factors affect delirium persistence. 2) To determine how ED delirium duration affects 6-month outcomes. To achieve these aims, we will perform a prospective cohort study thatwill enroll 125 older ED patients with delirium and a random selection of 125 older ED patients without delirium; both groups will comprise of admitted ED patients only. Once enrolled in the ED, we will assess patients for 7 days during hospitalization and perform phone follow-up at 6-months.
- Conditions
- Delirium
- Keywords
- delirium, emergency department, natural course, outcomes, elderly
- Medical subject headings
- Delirium, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Delirious in the ED | Patients who were delirious in the ED at either the 0-hour or 3-hour delirium assessment. | |
| Non-Delirious in the ED | Patients who were non-delirious in the ED at both the 0-hour or 3-hour delirium assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month mortality and functional status.
We will perform 6-month phone follow-up to ascertain death and functional status.
Measured: 6-months
Emergency department delirium duration
Patients will be enrolled in the emergency department and will be assessed for delirium daily until hospital day #7 or hospital discharge.
Measured: Until hospital discharge or the first 7-days of hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2012 (estimated)
- Study start1 Mar 2012
- Primary completion30 Nov 2014
- Study completion30 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin H. Han, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01651897
- Sponsor's protocol ID
- 111580
- Acronym
- DELINEATE
- Status last verified
- Feb 2017
- First submitted
- 25 Jul 2012
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium in the Emergency Department and Its Extension Into Hospitalization
- ClinicalTrials.gov ID
- NCT01651897
- Acronym / sponsor ID
- DELINEATE / 111580
- Conditions
- Delirium
- Keywords
- delirium, emergency department, natural course, outcomes, elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 1 Mar 2012 (actual)
- Primary completion
- 30 Nov 2014 (actual)
- Study completion
- 30 Apr 2015 (actual)
- First posted
- 27 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Delirium occurs in 10% of older emergency department (ED) patients, yet it remains poorly understood. To date, the predominance of delirium studies have been conducted in hospitalized patients and therefore have limited generalizability to the ED. Understanding ED delirium's natural course and its effect on outcomes is not well characterized. The investigators hypothesize that a significant proportion of patients who are delirious in the ED will remain delirious in the hospital, and persistent cases of ED delirium will be significantly associated with higher 6-month mortality and accelerated functional decline. To test this hypothesis, the investigators will perform a prospective cohort study that will enroll 150 older ED patients with delirium and a random selection of 150 older ED patients without delirium; both groups will comprise of admitted ED patients only. Once enrolled in the ED, the investigators will assess patients for 7 days during hospitalization and perform phone follow-up at 6-months.
Detailed description
Delirium is an acute confusional state characterized by fluctuating mental status, inattention, and either disorganized thinking or an altered level of consciousness. The prevalence of delirium in elderly patients is approximately 10% in emergency department (ED) patients. Several hospital-based studies have shown delirium to be associated with worsening mortality,longer hospital length of stay, higher health care costs,and poorer long-term functional and cognitive function.
However, delirium in the ED remains poorly understood. Specifically, its natural course is not well characterized and represents a critical gap in knowledge. Improving our understanding is paramount for several reasons. If the majority of delirium persists beyond the ED and is associated with long-term adverse outcomes, then routine delirium surveillance in the busy ED environment can be justified. Understanding the natural course may also help physicians identify delirious patients at highest risk for adverse outcomes and would be the focus of future delirium interventions. Lastly, we don't know if all patients with delirium require an admission. Understanding the natural course may help identify delirious patients that can be safely discharged home and those who require a hospital admission.
Given this paucity of data, we are conducting this study with the following specific aims: 1) To describe the frequency in which delirium in the ED persists into hospitalization and determine how patient factors and clinical factors affect delirium persistence. 2) To determine how ED delirium duration affects 6-month outcomes. To achieve these aims, we will perform a prospective cohort study thatwill enroll 125 older ED patients with delirium and a random selection of 125 older ED patients without delirium; both groups will comprise of admitted ED patients only. Once enrolled in the ED, we will assess patients for 7 days during hospitalization and perform phone follow-up at 6-months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirious in the ED | – | –Patients who were delirious in the ED at either the 0-hour or 3-hour delirium assessment. |
| Non-Delirious in the ED | – | –Patients who were non-delirious in the ED at both the 0-hour or 3-hour delirium assessment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- We will enroll 150 delirious ED patients and a random selection of 150 non-delirious ED patients who are hospitalized and reassess their delirium status daily throughout their hospitalization.
Key inclusion criteria (3 listed)
- 65 Years and older
- In an ED bed for less than 4 hours at the time of enrollment
- Any possibility of being admitted to the hospital
Key exclusion criteria (7 listed)
- Refuse consent
- Have been previously enrolled
- Unarousable to verbal stimuli
- Have severe mental retardation or severe dementia characterized by being non-verbal or unable to comprehend simple instructions at baseline
- Deaf
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
6-month mortality and functional status.
Time frame: 6-months
We will perform 6-month phone follow-up to ascertain death and functional status.
Emergency department delirium duration
Time frame: Until hospital discharge or the first 7-days of hospitalization.
Patients will be enrolled in the emergency department and will be assessed for delirium daily until hospital day #7 or hospital discharge.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month mortality and functional status. (time frame: 6-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.