Clinical trial NCT01358110: Emergency Department-Based Palliative Care for Advanced Cancer Patients
Official title: Emergency Department-Based Palliative Care for Advanced Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Cancer
Metastatic Cancer
Keywords: palliative care
cancer
emergency medicine
end- of- life care
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2011-05-23
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life and quality of mental health at 6 weeks and 12 weeks as compared from baseline
timeFrame: at baseline, 6 weeks and 12 weeks
Secondary outcomes:
measure: Inpatient costs per day/cost of stay during hospitalization
timeFrame: 6 months after hospital discharge
measure: Hospital length of stay
timeFrame: 6 months after hospital discharge
measure: Survival
timeFrame: at time of enrollment
measure: Readmissions within 6 months of discharge
timeFrame: 6 months from hospital discharge
measure: Repeat visits to the ED in 6 months
timeFrame: 6 months from hospital discharge
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Corita Grudzen, MD, MSHS
role: PRINCIPAL_INVESTIGATOR
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