Emergency Department-Based Palliative Care for Advanced Cancer Patients
25. června 2015 aktualizováno: Icahn School of Medicine at Mount Sinai
The purpose of this study is to: 1) identify the palliative care needs of Emergency Department patients with advanced cancer, and determine if these needs can be rapidly assessed in the ED; 2) determine whether early palliative care consultation improves survival, quality of life and other burdensome symptoms and decreases utilization as compared to usual care.
Přehled studie
Postavení
Dokončeno
Podmínky
Intervence / Léčba
Detailní popis
As the population ages, the number of individual living with cancer will continue to rise, and the number of Emergency Department (ED) visits for this population will continue to increase.
Cancer patients visit EDs because symptoms, such as pain or vomiting, can't be controlled at home, in an assisted living facility, or in their provider's office.
The ED is often the only place that can provide the necessary treatments as well as immediate access to technologically advanced testing for those with cancer.
However, palliative care (PC) services, such as relief of burdensome symptoms), attention to spiritual or social concerns, and establishing goals of care, is not standard care in the ED outside of a few medical centers.
Most patients do not have well-defined goals of care, and are often subjected to painful and marginally effective tests and procedures, not because they are consistent with their goals but because it is less time-consuming than discussing other options and has less perceived legal risk.
Until recently little emphasis has been placed on education, research, or guidelines for the delivery of PC services in this important setting.
While emergency providers could provide some of these services themselves, knowledge and skills regarding PC as well as staffing are currently inadequate to provide comprehensive services.
In addition to further decreasing days spent in the hospital and health care costs, consultation by a PC team for ED cancer patients might also reduce pain and other symptoms, aid in complex medical decision-making regarding testing and treatments, and facilitate transfer to hospice or home with visiting nurse services.
To enable PC consultation for ED cancer patients, the investigators will first determine who could benefit from emergent consultation, what services they need, and what characteristics of emergency providers and hospitals are preventing them from being offered.
To determine what affect PC consultation for patients with advanced cancer has on symptoms, discussions with patients and families about goals of care, and how long patients spend in the ED, the investigators will then randomly assign 200 ED cancer patients to targeted PC consultation versus usual or standard care.
Typ studie
Intervenční
Zápis (Aktuální)
136
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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New York
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New York, New York, Spojené státy, 10029
- Icahn School of Medicine at Mount Sinai
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
Inclusion Criteria:
- ≥ 18 years age
- Speak English or Spanish
- ED patient with an advanced solid malignancy
Exclusion Criteria:
- Have already been seen by palliative care team
- Cognitive deficits
- Children or adolescents
- No confirmed history of active cancer
- Do not speak English or Spanish
- Reside outside the US
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Early palliative care consultation
Early palliative care consultation for ED patients with advanced cancer.
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Patients will have symptoms assessed, have goals of care discussion with family and team present, and surrogate designated, as well as coordination of care and home services.
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Jiný: Care as usual
Care as usual, may or may not receive palliative care consultation
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Standard care as usual which may or may not include palliative care consultation
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline
Časové okno: at baseline, 6 weeks and 12 weeks
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Comparison of life and quality of mental health from baseline to 6 weeks and 12 weeks.
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at baseline, 6 weeks and 12 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Inpatient costs per day/cost of stay during hospitalization
Časové okno: 6 months after hospital discharge
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Costs per day during incident admission and total cost of entire incident hospital stay
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6 months after hospital discharge
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Hospital length of stay
Časové okno: 6 months after hospital discharge
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Number of days hospitalized for incident admission: i.e., date of admission and date of discharge, difference between those two dates.
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6 months after hospital discharge
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Survival
Časové okno: at time of enrollment
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Survival days from day of enrollment to day of death or study termination
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at time of enrollment
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Readmissions within 6 months of discharge
Časové okno: 6 months from hospital discharge
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6 months from hospital discharge
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Repeat visits to the ED in 6 months
Časové okno: 6 months from hospital discharge
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6 months from hospital discharge
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Corita Grudzen, MD, MSHS, Icahn School of Medicine at Mount Sinai
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
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Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. května 2011
Primární dokončení (Aktuální)
1. ledna 2015
Dokončení studie (Aktuální)
1. ledna 2015
Termíny zápisu do studia
První předloženo
19. května 2011
První předloženo, které splnilo kritéria kontroly kvality
20. května 2011
První zveřejněno (Odhad)
23. května 2011
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
26. června 2015
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
25. června 2015
Naposledy ověřeno
1. června 2015
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- GCO 08-1234
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