- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01162343
Delirium in the Emergency Department: Novel Screening
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Tennessee
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Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University Medical Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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Older Emergency Department Patients
Patients who were 65 years or older from the emergency department were enrolled.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Delirium
Tidsram: Within 3 hours of the study assessments.
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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.
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Within 3 hours of the study assessments.
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Jin H Han, MD, MSc, Vanderbilt University Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 081408
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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Kliniska prövningar på Delirium
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Efficacy Care R&D LtdHadassah Medical OrganizationOkändDelirium | Delirium, orsak okänd | Delirium av blandat ursprung | Delirium Förvirringstillstånd | Läkemedelsinducerad deliriumIsrael
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Johns Hopkins UniversityNational Institute on Aging (NIA)Aktiv, inte rekryterandeDelirium | Delirium vid uppkomst | Hörselnedsättning | Hörselnedsättning, högfrekvent | Hörselnedsättning, sensorineural | Delirium, orsak okänd | Hörselnedsättning, bilateral | Hörselnedsättning | Delirium i ålderdom | Delirium av blandat ursprung | Delirium överlagrat på demens | Delirium Förvirringstillstånd | Delirium... och andra villkorFörenta staterna
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Oslo University HospitalUniversity of Melbourne; Norwegian Academy of MusicAvslutadDelirium i ålderdom | Delirium av blandat ursprung | Delirium överlagrat på demens | Delirium FörvirringstillståndNorge
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Universidad de SantanderOkändDelirium av blandat ursprung | Hypoaktivt delirium | Hyperaktivt deliriumColombia
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Imperial College Healthcare NHS TrustRekryteringHjärtkirurgi | Intensivvårdsavdelning Delirium | Postoperativt deliriumStorbritannien
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Chinese PLA General HospitalBeijing Tiantan HospitalRekrytering
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Charite University, Berlin, GermanyBARMERRekryteringDelirium i ålderdomTyskland
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Qin ZhangNational Natural Science Foundation of ChinaRekrytering
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Qin ZhangNational Natural Science Foundation of ChinaRekryteringDelirium, postoperativtKina
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University Hospital, Basel, SwitzerlandInnosuisse - Swiss Innovation AgencyRekryteringPostoperativt delirium (POD)Schweiz