Emergency Department-Based Palliative Care for Advanced Cancer Patients
torstai 25. kesäkuuta 2015 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Valmis
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
136
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
-
-
New York
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New York, New York, Yhdysvallat, 10029
- Icahn School of Medicine at Mount Sinai
-
-
Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta ja vanhemmat (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
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Muut: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline
Aikaikkuna: 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
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Inpatient costs per day/cost of stay during hospitalization
Aikaikkuna: 6 months after hospital discharge
|
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
Aikaikkuna: 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.
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6 months after hospital discharge
|
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Survival
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 6 months from hospital discharge
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6 months from hospital discharge
|
Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Yhteistyökumppanit
Tutkijat
- Päätutkija: Corita Grudzen, MD, MSHS, Icahn School of Medicine at Mount Sinai
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Torstai 25. kesäkuuta 2015
Viimeksi vahvistettu
Maanantai 1. kesäkuuta 2015
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Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- GCO 08-1234
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