- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01651897
Delirium in the Emergency Department and Its Extension Into Hospitalization (DELINEATE)
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
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Tennessee
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Nashville, Tennessee, Forente stater, 37232
- Vanderbilt University Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
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Delirious in the ED
Patients who were delirious in the ED at either the 0-hour or 3-hour delirium assessment.
|
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Non-Delirious in the ED
Patients who were non-delirious in the ED at both the 0-hour or 3-hour delirium assessment.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
6-month mortality and functional status.
Tidsramme: 6-months
|
We will perform 6-month phone follow-up to ascertain death and functional status.
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6-months
|
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Emergency department delirium duration
Tidsramme: Until hospital discharge or the first 7-days of hospitalization.
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Patients will be enrolled in the emergency department and will be assessed for delirium daily until hospital day #7 or hospital discharge.
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Until hospital discharge or the first 7-days of hospitalization.
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 111580
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