Emergency Department-Based Palliative Care for Advanced Cancer Patients
25 giugno 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
136
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
New York
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New York, New York, Stati Uniti, 10029
- Icahn School of Medicine at Mount Sinai
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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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Altro: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Inpatient costs per day/cost of stay during hospitalization
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: at time of enrollment
|
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
Lasso di tempo: 6 months from hospital discharge
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6 months from hospital discharge
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|
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Repeat visits to the ED in 6 months
Lasso di tempo: 6 months from hospital discharge
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6 months from hospital discharge
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Collaboratori
Investigatori
- Investigatore principale: Corita Grudzen, MD, MSHS, Icahn School of Medicine at Mount Sinai
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 maggio 2011
Completamento primario (Effettivo)
1 gennaio 2015
Completamento dello studio (Effettivo)
1 gennaio 2015
Date di iscrizione allo studio
Primo inviato
19 maggio 2011
Primo inviato che soddisfa i criteri di controllo qualità
20 maggio 2011
Primo Inserito (Stima)
23 maggio 2011
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
26 giugno 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
25 giugno 2015
Ultimo verificato
1 giugno 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- GCO 08-1234
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