Emergency Department-Based Palliative Care for Advanced Cancer Patients
25. juni 2015 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
136
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
-
-
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
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Early palliative care consultation
Early palliative care consultation for ED patients with advanced cancer.
|
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.
|
|
Andet: Care as usual
Care as usual, may or may not receive palliative care consultation
|
Standard care as usual which may or may not include palliative care consultation
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline
Tidsramme: at baseline, 6 weeks and 12 weeks
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Inpatient costs per day/cost of stay during hospitalization
Tidsramme: 6 months after hospital discharge
|
Costs per day during incident admission and total cost of entire incident hospital stay
|
6 months after hospital discharge
|
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Hospital length of stay
Tidsramme: 6 months after hospital discharge
|
Number of days hospitalized for incident admission: i.e., date of admission and date of discharge, difference between those two dates.
|
6 months after hospital discharge
|
|
Survival
Tidsramme: at time of enrollment
|
Survival days from day of enrollment to day of death or study termination
|
at time of enrollment
|
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Readmissions within 6 months of discharge
Tidsramme: 6 months from hospital discharge
|
6 months from hospital discharge
|
|
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Repeat visits to the ED in 6 months
Tidsramme: 6 months from hospital discharge
|
6 months from hospital discharge
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Corita Grudzen, MD, MSHS, Icahn School of Medicine at Mount Sinai
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
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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
1. maj 2011
Primær færdiggørelse (Faktiske)
1. januar 2015
Studieafslutning (Faktiske)
1. januar 2015
Datoer for studieregistrering
Først indsendt
19. maj 2011
Først indsendt, der opfyldte QC-kriterier
20. maj 2011
Først opslået (Skøn)
23. maj 2011
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
26. juni 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. juni 2015
Sidst verificeret
1. juni 2015
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCO 08-1234
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