- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01651897
Delirium in the Emergency Department and Its Extension Into Hospitalization (DELINEATE)
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Tennessee
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Nashville, Tennessee, Spojené státy, 37232
- Vanderbilt University Medical Center
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
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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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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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6-month mortality and functional status.
Časové okno: 6-months
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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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 111580
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