Emergency Department-Based Palliative Care for Advanced Cancer Patients
25 de junho de 2015 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 de estudo
Intervencional
Inscrição (Real)
136
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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New York
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New York, New York, Estados Unidos, 10029
- Icahn School of Medicine at Mount Sinai
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Outro: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Inpatient costs per day/cost of stay during hospitalization
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 6 months from hospital discharge
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6 months from hospital discharge
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Corita Grudzen, MD, MSHS, Icahn School of Medicine at Mount Sinai
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de maio de 2011
Conclusão Primária (Real)
1 de janeiro de 2015
Conclusão do estudo (Real)
1 de janeiro de 2015
Datas de inscrição no estudo
Enviado pela primeira vez
19 de maio de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de maio de 2011
Primeira postagem (Estimativa)
23 de maio de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
26 de junho de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
25 de junho de 2015
Última verificação
1 de junho de 2015
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- GCO 08-1234
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