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Delirium in the Emergency Department and Its Extension Into Hospitalization (DELINEATE)

25. februar 2017 opdateret af: Jin H. Han, Vanderbilt University

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.

Studieoversigt

Status

Afsluttet

Betingelser

Delirium

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

228

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Tennessee
  - Nashville, Tennessee, Forenede Stater, 37232
    - Vanderbilt University Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal grupper/kohorter

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
6-month mortality and functional status. Tidsramme: 6-months	We will perform 6-month phone follow-up to ascertain death and functional status.	6-months
Emergency department delirium duration Tidsramme: 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.	Until hospital discharge or the first 7-days of hospitalization.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Vanderbilt University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2012

Primær færdiggørelse (Faktiske)

30. november 2014

Studieafslutning (Faktiske)

30. april 2015

Datoer for studieregistrering

Først indsendt

25. juli 2012

Først indsendt, der opfyldte QC-kriterier

26. juli 2012

Først opslået (Skøn)

27. juli 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. februar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. februar 2017

Sidst verificeret

1. februar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

111580

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .